- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03694002
Carboplatin and Paclitaxel With or Without Ramucirumab in Treating Patients With Locally Advanced, Recurrent, or Metastatic Thymic Cancer That Cannot Be Removed by Surgery
A Randomized Phase II Trial of Carboplatin-Paclitaxel With or Without Ramucirumab in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic Thymic Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To compare progression-free survival between patients with incurable unresectable locally advanced, or recurrent, or metastatic thymic carcinoma randomized to carboplatin-paclitaxel with or without ramucirumab.
SECONDARY OBJECTIVES:
I. To evaluate the frequency and severity of toxicity of carboplatin-paclitaxel with or without ramucirumab in this patient population.
II. To compare the response rate (complete response, partial response, confirmed and unconfirmed) between treatment arms.
III. To compare disease control rate (complete response, partial response, confirmed or unconfirmed, stable disease) between treatment arms.
IV. To compare overall survival between treatment arms.
ADDITIONAL OBJECTIVE:
I. To bank specimens for future research.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive ramucirumab intravenously (IV) over 60 minutes, carboplatin IV, and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not progressed may continue to receive ramucirumab for up to 1 year.
ARM B: Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year, and then every 6 months for 1 year.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alaska
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Anchorage, Alaska, United States, 98508
- Anchorage Associates in Radiation Medicine
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Anchorage, Alaska, United States, 99508
- Alaska Breast Care and Surgery LLC
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Anchorage, Alaska, United States, 99508
- Alaska Oncology and Hematology LLC
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Anchorage, Alaska, United States, 99508
- Alaska Women's Cancer Care
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Anchorage, Alaska, United States, 99508
- Anchorage Oncology Centre
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Anchorage, Alaska, United States, 99508
- Katmai Oncology Group
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Anchorage, Alaska, United States, 99508
- Providence Alaska Medical Center
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Anchorage, Alaska, United States, 99504
- Anchorage Radiation Therapy Center
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Arizona
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Kingman, Arizona, United States, 86401
- Kingman Regional Medical Center
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Arkansas
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Hot Springs, Arkansas, United States, 71913
- CHI Saint Vincent Cancer Center Hot Springs
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California
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Arroyo Grande, California, United States, 93420
- PCR Oncology
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Arroyo Grande, California, United States, 93420
- Mission Hope Medical Oncology - Arroyo Grande
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Burbank, California, United States, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Duarte, California, United States, 91010
- City of Hope Comprehensive Cancer Center
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Lancaster, California, United States, 93534
- City of Hope Antelope Valley
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Marysville, California, United States, 95901
- Fremont - Rideout Cancer Center
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Mission Hills, California, United States, 91345
- City of Hope Mission Hills
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Sacramento, California, United States, 95817
- University of California Davis Comprehensive Cancer Center
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Santa Maria, California, United States, 93444
- Mission Hope Medical Oncology - Santa Maria
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South Pasadena, California, United States, 91030
- City of Hope South Pasadena
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West Covina, California, United States, 91790
- City of Hope West Covina
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Colorado
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Colorado Springs, Colorado, United States, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, United States, 80907
- Rocky Mountain Cancer Centers-Penrose
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Denver, Colorado, United States, 80210
- Porter Adventist Hospital
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Durango, Colorado, United States, 81301
- Mercy Medical Center
-
Durango, Colorado, United States, 81301
- Southwest Oncology PC
-
Golden, Colorado, United States, 80401
- Mountain Blue Cancer Care Center
-
Lakewood, Colorado, United States, 80228
- Saint Anthony Hospital
-
Lakewood, Colorado, United States, 80228
- Rocky Mountain Cancer Centers-Lakewood
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Littleton, Colorado, United States, 80122
- Littleton Adventist Hospital
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Longmont, Colorado, United States, 80501
- Longmont United Hospital
-
Longmont, Colorado, United States, 80501
- Rocky Mountain Cancer Centers-Longmont
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Parker, Colorado, United States, 80138
- Parker Adventist Hospital
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Parker, Colorado, United States, 80138
- Rocky Mountain Cancer Centers-Parker
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Pueblo, Colorado, United States, 81004
- Saint Mary Corwin Medical Center
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Pueblo, Colorado, United States, 81008
- Rocky Mountain Cancer Centers - Pueblo
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Thornton, Colorado, United States, 80260
- Rocky Mountain Cancer Centers-Thornton
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Florida
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Tampa, Florida, United States, 33612
- Moffitt Cancer Center
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Tampa, Florida, United States, 33607
- Moffitt Cancer Center-International Plaza
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Tampa, Florida, United States, 33612
- Moffitt Cancer Center - McKinley Campus
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Idaho
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Boise, Idaho, United States, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Boise, Idaho, United States, 83712
- Saint Luke's Mountain States Tumor Institute
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Caldwell, Idaho, United States, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
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Coeur d'Alene, Idaho, United States, 83814
- Kootenai Medical Center
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Emmett, Idaho, United States, 83617
- Walter Knox Memorial Hospital
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Fruitland, Idaho, United States, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, United States, 83642
- Idaho Urologic Institute-Meridian
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Meridian, Idaho, United States, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, United States, 83686
- Saint Alphonsus Medical Center-Nampa
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Nampa, Idaho, United States, 83686
- Saint Luke's Cancer Institute - Nampa
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Post Falls, Idaho, United States, 83854
- Kootenai Cancer Center
-
Sandpoint, Idaho, United States, 83864
- Kootenai Cancer Clinic
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Twin Falls, Idaho, United States, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Lake Forest, Illinois, United States, 60045
- Northwestern Medicine Lake Forest Hospital
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Iowa
-
Clive, Iowa, United States, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, United States, 50325
- Medical Oncology and Hematology Associates-West Des Moines
-
Council Bluffs, Iowa, United States, 51503
- Alegent Health Mercy Hospital
-
Creston, Iowa, United States, 50801
- Greater Regional Medical Center
-
Des Moines, Iowa, United States, 50314
- Mercy Medical Center - Des Moines
-
Des Moines, Iowa, United States, 50314
- Medical Oncology and Hematology Associates-Laurel
-
West Des Moines, Iowa, United States, 50266
- Mercy Medical Center-West Lakes
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Kentucky
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Bardstown, Kentucky, United States, 40004
- Flaget Memorial Hospital
-
Corbin, Kentucky, United States, 40701
- Commonwealth Cancer Center-Corbin
-
Lexington, Kentucky, United States, 40504
- Saint Joseph Radiation Oncology Resource Center
-
Lexington, Kentucky, United States, 40509
- Saint Joseph Hospital East
-
London, Kentucky, United States, 40741
- Saint Joseph London
-
Louisville, Kentucky, United States, 40202
- Jewish Hospital
-
Louisville, Kentucky, United States, 40215
- Saints Mary and Elizabeth Hospital
-
Louisville, Kentucky, United States, 40245
- Jewish Hospital Medical Center Northeast
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Shepherdsville, Kentucky, United States, 40165
- Jewish Hospital Medical Center South
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Maryland
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Baltimore, Maryland, United States, 21204
- Greater Baltimore Medical Center
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Michigan
-
Brownstown, Michigan, United States, 48183
- Henry Ford Cancer Institute-Downriver
-
Clinton Township, Michigan, United States, 48038
- Henry Ford Macomb Hospital-Clinton Township
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Dearborn, Michigan, United States, 48126
- Henry Ford Medical Center-Fairlane
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Jackson, Michigan, United States, 49201
- Allegiance Health
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Novi, Michigan, United States, 48377
- Henry Ford Medical Center-Columbus
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Shelby, Michigan, United States, 48315
- Henry Ford Macomb Health Center - Shelby Township
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West Bloomfield, Michigan, United States, 48322
- Henry Ford West Bloomfield Hospital
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Minnesota
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Burnsville, Minnesota, United States, 55337
- Fairview Ridges Hospital
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Burnsville, Minnesota, United States, 55337
- Minnesota Oncology - Burnsville
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Cambridge, Minnesota, United States, 55008
- Cambridge Medical Center
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Coon Rapids, Minnesota, United States, 55433
- Mercy Hospital
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Edina, Minnesota, United States, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, United States, 55432
- Unity Hospital
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Maple Grove, Minnesota, United States, 55369
- Fairview Clinics and Surgery Center Maple Grove
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Maplewood, Minnesota, United States, 55109
- Saint John's Hospital - Healtheast
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Maplewood, Minnesota, United States, 55109
- Minnesota Oncology Hematology PA-Maplewood
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Minneapolis, Minnesota, United States, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, United States, 55407
- Abbott-Northwestern Hospital
-
Minneapolis, Minnesota, United States, 55454
- Health Partners Inc
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Monticello, Minnesota, United States, 55362
- Monticello Cancer Center
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New Ulm, Minnesota, United States, 56073
- New Ulm Medical Center
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Princeton, Minnesota, United States, 55371
- Fairview Northland Medical Center
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Robbinsdale, Minnesota, United States, 55422
- North Memorial Medical Health Center
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Saint Louis Park, Minnesota, United States, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, United States, 55101
- Regions Hospital
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Saint Paul, Minnesota, United States, 55102
- United Hospital
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Shakopee, Minnesota, United States, 55379
- Saint Francis Regional Medical Center
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Stillwater, Minnesota, United States, 55082
- Lakeview Hospital
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Waconia, Minnesota, United States, 55387
- Ridgeview Medical Center
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Willmar, Minnesota, United States, 56201
- Rice Memorial Hospital
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Woodbury, Minnesota, United States, 55125
- Minnesota Oncology Hematology PA-Woodbury
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Wyoming, Minnesota, United States, 55092
- Fairview Lakes Medical Center
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Mississippi
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Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
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Montana
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Anaconda, Montana, United States, 59711
- Community Hospital of Anaconda
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Billings, Montana, United States, 59101
- Billings Clinic Cancer Center
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Bozeman, Montana, United States, 59715
- Bozeman Deaconess Hospital
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Great Falls, Montana, United States, 59405
- Great Falls Clinic
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Great Falls, Montana, United States, 59405
- Benefis Healthcare- Sletten Cancer Institute
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Helena, Montana, United States, 59601
- Saint Peter's Community Hospital
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Kalispell, Montana, United States, 59901
- Kalispell Regional Medical Center
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Missoula, Montana, United States, 59804
- Community Medical Hospital
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Missoula, Montana, United States, 59802
- Saint Patrick Hospital - Community Hospital
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Nebraska
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Grand Island, Nebraska, United States, 68803
- CHI Health Saint Francis
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Kearney, Nebraska, United States, 68847
- CHI Health Good Samaritan
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Kearney, Nebraska, United States, 68845
- Heartland Hematology and Oncology
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Lincoln, Nebraska, United States, 68510
- Saint Elizabeth Regional Medical Center
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Omaha, Nebraska, United States, 68124
- Alegent Health Bergan Mercy Medical Center
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Omaha, Nebraska, United States, 68122
- Alegent Health Immanuel Medical Center
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Omaha, Nebraska, United States, 68130
- Alegent Health Lakeside Hospital
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Omaha, Nebraska, United States, 68131
- Creighton University Medical Center
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Omaha, Nebraska, United States, 68122
- Hematology and Oncology Consultants PC
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Papillion, Nebraska, United States, 68046
- Midlands Community Hospital
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Nevada
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Carson City, Nevada, United States, 89703
- Carson Tahoe Regional Medical Center
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Henderson, Nevada, United States, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
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Henderson, Nevada, United States, 89052
- OptumCare Cancer Care at Seven Hills
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Henderson, Nevada, United States, 89052
- Cancer and Blood Specialists-Henderson
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Henderson, Nevada, United States, 89052
- Las Vegas Cancer Center-Henderson
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Henderson, Nevada, United States, 89074
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
-
Henderson, Nevada, United States, 89074
- 21st Century Oncology-Henderson
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Henderson, Nevada, United States, 89052
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
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Henderson, Nevada, United States, 89074
- Las Vegas Urology - Green Valley
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Henderson, Nevada, United States, 89074
- Las Vegas Urology - Pebble
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Henderson, Nevada, United States, 89074
- Urology Specialists of Nevada - Green Valley
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Las Vegas, Nevada, United States, 89144
- Summerlin Hospital Medical Center
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Las Vegas, Nevada, United States, 89109
- Sunrise Hospital and Medical Center
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Las Vegas, Nevada, United States, 89106
- Radiation Oncology Centers of Nevada Central
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Las Vegas, Nevada, United States, 89119
- Radiation Oncology Centers of Nevada Southeast
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Las Vegas, Nevada, United States, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
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Las Vegas, Nevada, United States, 89128
- OptumCare Cancer Care at MountainView
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Las Vegas, Nevada, United States, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Las Vegas, Nevada, United States, 89144
- Comprehensive Cancer Centers of Nevada - Town Center
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Las Vegas, Nevada, United States, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
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Las Vegas, Nevada, United States, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, United States, 89148
- OptumCare Cancer Care at Fort Apache
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Las Vegas, Nevada, United States, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
-
Las Vegas, Nevada, United States, 89102
- University Medical Center of Southern Nevada
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Las Vegas, Nevada, United States, 89106
- Cancer and Blood Specialists-Shadow
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Las Vegas, Nevada, United States, 89109
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
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Las Vegas, Nevada, United States, 89113
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
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Las Vegas, Nevada, United States, 89128
- Cancer and Blood Specialists-Tenaya
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Las Vegas, Nevada, United States, 89128
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
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Las Vegas, Nevada, United States, 89148-2405
- Las Vegas Cancer Center-Medical Center
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Las Vegas, Nevada, United States, 89149
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
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Las Vegas, Nevada, United States, 89109
- 21st Century Oncology
-
Las Vegas, Nevada, United States, 89128
- 21st Century Oncology-Vegas Tenaya
-
Las Vegas, Nevada, United States, 89148
- 21st Century Oncology-Fort Apache
-
Las Vegas, Nevada, United States, 89128
- Ann M Wierman MD LTD
-
Las Vegas, Nevada, United States, 89074
- Las Vegas Urology - Pecos
-
Las Vegas, Nevada, United States, 89102
- Desert West Surgery
-
Las Vegas, Nevada, United States, 89102
- OptumCare Cancer Care at Oakey
-
Las Vegas, Nevada, United States, 89103
- Hope Cancer Care of Nevada
-
Las Vegas, Nevada, United States, 89106
- Urology Specialists of Nevada - Central
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Las Vegas, Nevada, United States, 89113
- Las Vegas Prostate Cancer Center
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Las Vegas, Nevada, United States, 89113
- Las Vegas Urology - Sunset
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Las Vegas, Nevada, United States, 89128
- Las Vegas Urology - Cathedral Rock
-
Las Vegas, Nevada, United States, 89128
- Las Vegas Urology - Smoke Ranch
-
Las Vegas, Nevada, United States, 89128
- Urology Specialists of Nevada - Northwest
-
Las Vegas, Nevada, United States, 89148
- Urology Specialists of Nevada - Southwest
-
Las Vegas, Nevada, United States, 89169
- University Cancer Center
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Pahrump, Nevada, United States, 89048
- Hope Cancer Care of Nevada-Pahrump
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Reno, Nevada, United States, 89502
- Renown Regional Medical Center
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Reno, Nevada, United States, 89503
- Saint Mary's Regional Medical Center
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Reno, Nevada, United States, 89509
- Radiation Oncology Associates
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New York
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New York, New York, United States, 10065
- NYP/Weill Cornell Medical Center
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Syracuse, New York, United States, 13210
- State University of New York Upstate Medical University
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Ohio
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Cincinnati, Ohio, United States, 45220
- Good Samaritan Hospital - Cincinnati
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Cincinnati, Ohio, United States, 45242
- Bethesda North Hospital
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Cincinnati, Ohio, United States, 45247
- TriHealth Cancer Institute-Westside
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Cincinnati, Ohio, United States, 45255
- TriHealth Cancer Institute-Anderson
-
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Oregon
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Baker City, Oregon, United States, 97814
- Saint Alphonsus Medical Center-Baker City
-
Bend, Oregon, United States, 97701
- Saint Charles Health System
-
Clackamas, Oregon, United States, 97015
- Clackamas Radiation Oncology Center
-
Clackamas, Oregon, United States, 97015
- Providence Cancer Institute Clackamas Clinic
-
Coos Bay, Oregon, United States, 97420
- Bay Area Hospital
-
Newberg, Oregon, United States, 97132
- Providence Newberg Medical Center
-
Ontario, Oregon, United States, 97914
- Saint Alphonsus Medical Center-Ontario
-
Portland, Oregon, United States, 97213
- Providence Portland Medical Center
-
Portland, Oregon, United States, 97225
- Providence Saint Vincent Medical Center
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Redmond, Oregon, United States, 97756
- Saint Charles Health System-Redmond
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Pennsylvania
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Harrisburg, Pennsylvania, United States, 17109
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
-
Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
-
Pittsburgh, Pennsylvania, United States, 15232
- University of Pittsburgh Cancer Institute (UPCI)
-
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South Carolina
-
Easley, South Carolina, United States, 29640
- Prisma Health Cancer Institute - Easley
-
Greenville, South Carolina, United States, 29605
- Prisma Health Cancer Institute - Faris
-
Greenville, South Carolina, United States, 29615
- Prisma Health Cancer Institute - Eastside
-
Greenville, South Carolina, United States, 29605
- Prisma Health Cancer Institute - Butternut
-
Greer, South Carolina, United States, 29650
- Prisma Health Cancer Institute - Greer
-
Seneca, South Carolina, United States, 29672
- Prisma Health Cancer Institute - Seneca
-
Spartanburg, South Carolina, United States, 29307
- Prisma Health Cancer Institute - Spartanburg
-
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Tennessee
-
Chattanooga, Tennessee, United States, 37404
- Memorial Hospital
-
Hixson, Tennessee, United States, 37343
- Pulmonary Medicine Center of Chattanooga-Hixson
-
Ooltewah, Tennessee, United States, 37363
- Memorial GYN Plus
-
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Texas
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Bryan, Texas, United States, 77802
- Saint Joseph Regional Cancer Center
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
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Utah
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Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute/University of Utah
-
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Washington
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Aberdeen, Washington, United States, 98520
- Providence Regional Cancer System-Aberdeen
-
Bellevue, Washington, United States, 98004
- Overlake Medical Center
-
Bellingham, Washington, United States, 98225
- PeaceHealth Saint Joseph Medical Center
-
Bremerton, Washington, United States, 98310
- Harrison HealthPartners Hematology and Oncology-Bremerton
-
Bremerton, Washington, United States, 98310
- Harrison Medical Center
-
Burien, Washington, United States, 98166
- Highline Medical Center-Main Campus
-
Centralia, Washington, United States, 98531
- Providence Regional Cancer System-Centralia
-
Edmonds, Washington, United States, 98026
- Swedish Cancer Institute-Edmonds
-
Enumclaw, Washington, United States, 98022
- Saint Elizabeth Hospital
-
Everett, Washington, United States, 98201
- Providence Regional Cancer Partnership
-
Federal Way, Washington, United States, 98003
- Saint Francis Hospital
-
Issaquah, Washington, United States, 98029
- Swedish Cancer Institute-Issaquah
-
Kennewick, Washington, United States, 99336
- Kadlec Clinic Hematology and Oncology
-
Lacey, Washington, United States, 98503
- Providence Regional Cancer System-Lacey
-
Lakewood, Washington, United States, 98499
- Saint Clare Hospital
-
Longview, Washington, United States, 98632
- PeaceHealth Saint John Medical Center
-
Poulsbo, Washington, United States, 98370
- Harrison HealthPartners Hematology and Oncology-Poulsbo
-
Renton, Washington, United States, 98055
- Valley Medical Center
-
Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center
-
Seattle, Washington, United States, 98109
- Seattle Cancer Care Alliance
-
Seattle, Washington, United States, 98195
- University of Washington Medical Center
-
Seattle, Washington, United States, 98107
- Swedish Medical Center-Ballard Campus
-
Seattle, Washington, United States, 98112
- Kaiser Permanente Washington
-
Seattle, Washington, United States, 98104
- Pacific Gynecology Specialists
-
Seattle, Washington, United States, 98122-4307
- Swedish Medical Center-First Hill
-
Seattle, Washington, United States, 98122-5711
- Swedish Medical Center-Cherry Hill
-
Sedro-Woolley, Washington, United States, 98284
- PeaceHealth United General Medical Center
-
Shelton, Washington, United States, 98584
- Providence Regional Cancer System-Shelton
-
Tacoma, Washington, United States, 98405
- Northwest Medical Specialties PLLC
-
Tacoma, Washington, United States, 98405
- Franciscan Research Center-Northwest Medical Plaza
-
Vancouver, Washington, United States, 98664
- PeaceHealth Southwest Medical Center
-
Walla Walla, Washington, United States, 99362
- Providence Saint Mary Regional Cancer Center
-
Yelm, Washington, United States, 98597
- Providence Regional Cancer System-Yelm
-
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Wisconsin
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Chippewa Falls, Wisconsin, United States, 54729
- Marshfield Clinic-Chippewa Center
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Eau Claire, Wisconsin, United States, 54701
- Marshfield Medical Center-EC Cancer Center
-
Ladysmith, Wisconsin, United States, 54848
- Marshfield Clinic - Ladysmith Center
-
Marshfield, Wisconsin, United States, 54449
- Marshfield Medical Center-Marshfield
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Minocqua, Wisconsin, United States, 54548
- Marshfield Clinic-Minocqua Center
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New Richmond, Wisconsin, United States, 54017
- Cancer Center of Western Wisconsin
-
Rice Lake, Wisconsin, United States, 54868
- Marshfield Medical Center-Rice Lake
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Stevens Point, Wisconsin, United States, 54482
- Marshfield Clinic Stevens Point Center
-
Wausau, Wisconsin, United States, 54401
- Marshfield Clinic-Wausau Center
-
Weston, Wisconsin, United States, 54476
- Marshfield Clinic - Weston Center
-
Wisconsin Rapids, Wisconsin, United States, 54494
- Marshfield Clinic - Wisconsin Rapids Center
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Wyoming
-
Cody, Wyoming, United States, 82414
- Billings Clinic-Cody
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Sheridan, Wyoming, United States, 82801
- Welch Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed thymic carcinoma; thymic carcinoma may be defined as "thymic epithelial malignancy, consistent with thymic carcinoma", or "World Health Organization (WHO) type C thymic epithelial tumor", or "thymic epithelial malignancy" with radiographic imaging consistent with thymic carcinoma
- Patients must have unresectable thymic carcinoma, that is either locally advanced, recurrent, or metastatic
- Patients must not be candidates for localized surgery
- Patients must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI) within 28 calendar days prior to randomization; the CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality; non-measurable disease must be assessed within 42 calendar days prior to randomization; all known sites of disease must be assessed and documented on the baseline tumor assessment form (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
- Patients must have a Zubrod performance status of 0 to 2
- Patients must not have undergone major surgery within 28 calendar days prior to randomization, or minor surgery/subcutaneous venous access device placement within 7 calendar days prior to randomization; the patient must not have elective or planned major surgery to be performed during the course of the clinical trial
- Patients must not have had prior systemic anti-cancer therapy for locally advanced or metastatic unresectable thymic carcinoma
- If patients have recurrent unresectable thymic carcinoma, patients may have had prior neoadjuvant or adjuvant chemotherapy if treatment concluded >= 6 months prior to randomization
- Patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 calendar days prior to registration; patient must not have brain metastases unless: (1) metastases have been treated and have remained controlled for at least two weeks following treatment, AND (2) patient has no residual neurological dysfunction off corticosteroids for at least 1 day
- Patients must not be candidates for radiation therapy with curative intent; prior palliative radiation therapy is allowed as long as a period of 7 days has passed since the last dose was received and the patient has recovered from any associated toxicity at the time of randomization
- Absolute neutrophil count (ANC) >= 1500/mcL documented within 28 calendar days prior to randomization
- Hemoglobin >= 9 g/dL (5.58 mmol/L) documented within 28 calendar days prior to randomization
- Platelets >= 100,000/mcL documented within 28 calendar days prior to randomization
- International normalized ratio (INR) =< 1.5 documented within 28 calendar days prior to randomization
- Partial thromboplastin time (PTT) =< 5 seconds above the institutional upper limit of normal (IULN) (unless receiving anticoagulation therapy) documented within 28 calendar days prior to randomization
- Patients receiving warfarin must be switched to low molecular weight heparin and have achieved stable coagulation profile 14 days prior to randomization
- Patients must not have experienced any grade 3 or above gastrointestinal (GI) bleeding within 84 calendar days prior to randomization
- Patients must not have a history of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant") during the 84 calendar days prior to randomization
- Total bilirubin =< 1.5 x the institutional upper limit normal (IULN) documented within 28 calendar days prior to randomization
- Aspartate aminotransferase (aspartate transaminase [AST]) and alanine aminotransferase (alanine transaminase [ALT]) =< 3.0 x IULN; for patients with liver metastases, total bilirubin and AST or ALT must be =< 5.0 x IULN documented within 28 calendar days prior to randomization
Patients must not have any of following:
- Cirrhosis at a level of Child-Pugh B (or worse)
- Cirrhosis (any degree) and a history of hepatic encephalopathy; or
- Clinically meaningful ascites resulting from cirrhosis; clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
- Serum creatinine =< 1.5 x IULN, or creatinine clearance (measured via 24-hour urine collection) >= 40 mL/minute (that is, if serum creatinine is > 1.5 x ULN, a 24-hour urine collection to calculate creatinine clearance must be performed) documented within 28 calendar days prior to randomization
- Patient urinary protein must be =< 1+ on dipstick or routine urinalysis (UA); if urine dipstick or routine analysis is >= 2+, a 24-hour urine collection for protein must demonstrate < 1000 mg of protein in 24 hours); these tests must be documented within 28 calendar days prior to randomization
- Patients must not have experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to randomization
- Patients must not have a history of uncontrolled or poorly-controlled hypertension (defined as > 160 mmHg systolic or > 100 mmHg diastolic for > 4 weeks) despite standard medical management
- Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method (hormonal or barrier method of birth control; abstinence) prior to randomization, during the study participation and for 4 months after the last dose of protocol treatment; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
- Patients must not have experienced hemoptysis (defined as bright red blood or >= 1/2 teaspoon) within 2 months prior to randomization or with radiographic evidence of intratumor cavitation or has radiologically documented evidence of major blood vessel invasion or encasement by cancer
- Patients must not have a prior history of gastrointestinal perforation/fistula (within 6 months of randomization) or risk factors for perforation
- Patients must not have a serious or nonhealing wound, ulcer, or bone fracture within 28 calendar days prior to randomization
- Patients must not be receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents within 7 days prior to randomization; once-daily aspirin use (maximum dose 325 mg/day) is permitted
- Patients must be offered the opportunity to participate in banking of specimens for future research
- Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A (ramucirumab, carboplatin, paclitaxel)
Patients receive ramucirumab IV over 60 minutes, carboplatin IV, and paclitaxel IV on day 1.
Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Patients who have not progressed may continue to receive ramucirumab for up to 1 year.
|
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
|
Active Comparator: Arm B (carboplatin, paclitaxel)
Patients receive carboplatin IV and paclitaxel IV on day 1.
Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
|
Given IV
Other Names:
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival
Time Frame: From date of registration to date of first documentation of progression or symptomatic, assessed up to 2 years
|
From date of registration to date of first documentation of progression or symptomatic, assessed up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events
Time Frame: Up to 2 years
|
Binary proportions will be compared between the arms using either a Fisher's exact or Chi-squared test at the 1-sided 0.10 level.
|
Up to 2 years
|
Response rate (complete response, partial response, confirmed and unconfirmed)
Time Frame: Up to 2 years
|
Binary proportions will be compared between the arms using either a Fisher's exact or Chi-squared test at the 1-sided 0.10 level.
|
Up to 2 years
|
Disease control rate (complete response, partial response, confirmed or unconfirmed, stable disease)
Time Frame: Up to 2 years
|
Binary proportions will be compared between the arms using either a Fisher's exact or Chi-squared test at the 1-sided 0.10 level.
|
Up to 2 years
|
Overall survival
Time Frame: Up to 2 years
|
Binary proportions will be compared between the arms using either a Fisher's exact or Chi-squared test at the 1-sided 0.10 level.
|
Up to 2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anne S Tsao, SWOG Cancer Research Network
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Lymphatic Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Thoracic Neoplasms
- Neoplasms, Complex and Mixed
- Thymus Neoplasms
- Carcinoma
- Recurrence
- Thymoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
- Antibodies
- Immunoglobulins
- Ramucirumab
- Albumin-Bound Paclitaxel
- Antibodies, Monoclonal
- Antineoplastic Agents, Immunological
- Lexatumumab
Other Study ID Numbers
- S1701 (Other Identifier: CTEP)
- U10CA180888 (U.S. NIH Grant/Contract)
- NCI-2017-02254 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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