Sorafenib and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer

August 7, 2017 updated by: Alliance for Clinical Trials in Oncology

Phase II Study of Sorafenib/Avastin® as Salvage Therapy in Patients With Metastatic Colorectal Cancer

This phase II trial is studying how well giving sorafenib together with bevacizumab works in treating patients with metastatic colorectal cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib and bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with bevacizumab may kill more tumor cells

Study Overview

Detailed Description

PRIMARY OBJECTIVES:

I. Evaluate proportion of patients who are progression-free at 3 months (in historic comparison with results for single-agent bevacizumab in ECOG 3200).

SECONDARY OBJECTIVES:

I. Response rate (RR) II. Overall survival (OS) III. Safety IV. Feasibility

OUTLINE: This is a multicenter study.

Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies.

After completion of study treatment, patients are followed periodically for up to 2 years.

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona
    • Colorado
      • Aurora, Colorado, United States, 80012
        • The Medical Center of Aurora
      • Boulder, Colorado, United States, 80301
        • Boulder Community Hospital
      • Colorado Springs, Colorado, United States, 80907
        • Penrose-Saint Francis Healthcare
      • Denver, Colorado, United States, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, United States, 80218
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, United States, 80220
        • Rose Medical Center
      • Denver, Colorado, United States, 80218
        • Exempla Saint Joseph Hospital
      • Denver, Colorado, United States, 80224-2522
        • Colorado Cancer Research Program CCOP
      • Denver, Colorado, United States, 80204
        • Saint Anthony Central Hospital
      • Englewood, Colorado, United States, 80110
        • Swedish Medical Center
      • Grand Junction, Colorado, United States, 81502
        • Saint Mary's Hospital and Regional Medical Center
      • Greeley, Colorado, United States, 80631
        • North Colorado Medical Center
      • Lone Tree, Colorado, United States, 80124
        • Sky Ridge Medical Center
      • Longmont, Colorado, United States, 80501
        • Longmont United Hospital
      • Loveland, Colorado, United States, 80539
        • McKee Medical Center
      • Pueblo, Colorado, United States, 81004
        • Saint Mary Corwin Medical Center
      • Thornton, Colorado, United States, 80229
        • North Suburban Medical Center
      • Wheat Ridge, Colorado, United States, 80033
        • Exempla Lutheran Medical Center
    • Florida
      • Jacksonville, Florida, United States, 32224-9980
        • Mayo Clinic in Florida
    • Illinois
      • Bloomington, Illinois, United States, 61701
        • Saint Joseph Medical Center
      • Canton, Illinois, United States, 61520
        • Graham Hospital Association
      • Carthage, Illinois, United States, 62321
        • Memorial Hospital
      • Eureka, Illinois, United States, 61530
        • Eureka Hospital
      • Galesburg, Illinois, United States, 61401
        • Galesburg Cottage Hospital
      • Galesburg, Illinois, United States, 61401
        • Galesburg Clinic
      • Havana, Illinois, United States, 62644
        • Mason District Hospital
      • Macomb, Illinois, United States, 61455
        • Mcdonough District Hospital
      • Moline, Illinois, United States, 61265
        • Garneau, Stewart C MD (UIA Investigator)
      • Moline, Illinois, United States, 61265
        • Porubcin, Michael MD (UIA Investigator)
      • Moline, Illinois, United States, 61265
        • Sharis, Christine M MD (UIA Investigator)
      • Moline, Illinois, United States, 61265
        • Stoffel, Thomas J MD (UIA Investigator)
      • Monmouth, Illinois, United States, 61462
        • Holy Family Medical Center
      • Normal, Illinois, United States, 61761
        • Community Cancer Center Foundation
      • Normal, Illinois, United States, 61761
        • Bromenn Regional Medical Center
      • Ottawa, Illinois, United States, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Ottawa, Illinois, United States, 61350
        • Ottawa Regional Hospital and Healthcare Center
      • Pekin, Illinois, United States, 61554
        • Pekin Cancer Treatment Center
      • Pekin, Illinois, United States, 61554
        • Pekin Hospital
      • Peoria, Illinois, United States, 61637
        • OSF Saint Francis Medical Center
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare-Peoria
      • Peoria, Illinois, United States, 61614
        • Proctor Hospital
      • Peoria, Illinois, United States, 61603
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, United States, 61615
        • Illinois Oncology Research Association CCOP
      • Peru, Illinois, United States, 61354
        • Illinois Valley Hospital
      • Princeton, Illinois, United States, 61356
        • Perry Memorial Hospital
      • Spring Valley, Illinois, United States, 61362
        • Saint Margaret's Hospital
    • Indiana
      • Beech Grove, Indiana, United States, 46107
        • Saint Francis Hospital and Health Centers
      • Elkhart, Indiana, United States, 46515
        • Elkhart General Hospital
      • Kokomo, Indiana, United States, 46904
        • Community Howard Regional Health
      • La Porte, Indiana, United States, 46350
        • Indiana University Health La Porte Hospital
      • Mishawaka, Indiana, United States, 46545-1470
        • Saint Joseph Regional Medical Center-Mishawaka
      • Richmond, Indiana, United States, 47374
        • Reid Hospital and Health Care Services
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, United States, 46617
        • South Bend Clinic
      • South Bend, Indiana, United States, 46601
        • Northern Indiana Cancer Research Consortium
    • Iowa
      • Bettendorf, Iowa, United States, 52722
        • Constantinou, Costas L MD (UIA Investigator)
      • Cedar Rapids, Iowa, United States, 52403
        • Mercy Hospital
      • Cedar Rapids, Iowa, United States, 52403
        • Oncology Associates at Mercy Medical Center
      • Cedar Rapids, Iowa, United States, 52403
        • Cedar Rapids Oncology Association
      • Clive, Iowa, United States, 50325
        • Medical Oncology and Hematology Associates-West Des Moines
      • Des Moines, Iowa, United States, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, United States, 50309
        • Medical Oncology and Hematology Associates-Des Moines
      • Des Moines, Iowa, United States, 50316
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, United States, 50307
        • Mercy Capitol
      • Des Moines, Iowa, United States, 50309
        • Iowa Oncology Research Association CCOP
      • Des Moines, Iowa, United States, 50314
        • Medical Oncology and Hematology Associates
      • Mason City, Iowa, United States, 50401
        • Mercy Medical Center - North Iowa
      • Sioux City, Iowa, United States, 51104
        • Saint Luke's Regional Medical Center
      • Sioux City, Iowa, United States, 51101
        • Siouxland Hematology Oncology Associates
      • Sioux City, Iowa, United States, 51104
        • Mercy Medical Center-Sioux City
    • Kansas
      • Anthony, Kansas, United States, 67003
        • Hospital District Sixth of Harper County
      • Chanute, Kansas, United States, 66720
        • Cancer Center of Kansas - Chanute
      • Dodge City, Kansas, United States, 67801
        • Cancer Center of Kansas - Dodge City
      • El Dorado, Kansas, United States, 67042
        • Cancer Center of Kansas - El Dorado
      • Fort Scott, Kansas, United States, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, United States, 67301
        • Cancer Center of Kansas-Independence
      • Kingman, Kansas, United States, 67068
        • Cancer Center of Kansas-Kingman
      • Lawrence, Kansas, United States, 66044
        • Lawrence Memorial Hospital
      • Newton, Kansas, United States, 67114
        • Cancer Center of Kansas - Newton
      • Parsons, Kansas, United States, 67357
        • Cancer Center of Kansas - Parsons
      • Pratt, Kansas, United States, 67124
        • Cancer Center of Kansas - Pratt
      • Salina, Kansas, United States, 67401
        • Cancer Center of Kansas - Salina
      • Wellington, Kansas, United States, 67152
        • Cancer Center of Kansas - Wellington
      • Wichita, Kansas, United States, 67208
        • Cancer Center of Kansas-Wichita Medical Arts Tower
      • Wichita, Kansas, United States, 67208
        • Associates In Womens Health
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas - Main Office
      • Wichita, Kansas, United States, 67214
        • Via Christi Regional Medical Center
      • Wichita, Kansas, United States, 67214
        • Wichita CCOP
      • Winfield, Kansas, United States, 67156
        • Cancer Center of Kansas - Winfield
    • Michigan
      • Adrian, Michigan, United States, 49221
        • Bixby Medical Center
      • Adrian, Michigan, United States, 49221
        • Hickman Cancer Center
      • Ann Arbor, Michigan, United States, 48106-0995
        • Saint Joseph Mercy Hospital
      • Ann Arbor, Michigan, United States, 48106
        • Michigan Cancer Research Consortium Community Clinical Oncology Program
      • Dearborn, Michigan, United States, 48124
        • Oakwood Hospital
      • Detroit, Michigan, United States, 48236
        • Saint John Hospital and Medical Center
      • Escanaba, Michigan, United States, 49431
        • Green Bay Oncology - Escanaba
      • Flint, Michigan, United States, 48502
        • Hurley Medical Center
      • Flint, Michigan, United States, 48532
        • Genesys Regional Medical Center-West Flint Campus
      • Iron Mountain, Michigan, United States, 49801
        • Green Bay Oncology - Iron Mountain
      • Jackson, Michigan, United States, 49201
        • Allegiance Health
      • Lansing, Michigan, United States, 48912
        • Sparrow Hospital
      • Livonia, Michigan, United States, 48154
        • Saint Mary Mercy Hospital
      • Monroe, Michigan, United States, 48162
        • Mercy Memorial Hospital
      • Monroe, Michigan, United States, 48162
        • Community Cancer Center of Monroe
      • Pontiac, Michigan, United States, 48341-2985
        • Saint Joseph Mercy Oakland
      • Port Huron, Michigan, United States, 48060
        • Saint Joseph Mercy Port Huron
      • Saginaw, Michigan, United States, 48601
        • Saint Mary's of Michigan
      • Saint Joseph, Michigan, United States, 49085
        • Lakeland Hospital
      • Warren, Michigan, United States, 48093
        • Saint John Macomb-Oakland Hospital
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
        • Sanford Clinic North-Bemidgi
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Duluth, Minnesota, United States, 55805
        • Essentia Health Saint Mary's Medical Center
      • Duluth, Minnesota, United States, 55805
        • Miller-Dwan Hospital
      • Duluth, Minnesota, United States, 55805
        • Essentia Health Duluth Clinic CCOP
      • Edina, Minnesota, United States, 55435
        • Fairview-Southdale Hospital
      • Fridley, Minnesota, United States, 55432
        • Unity Hospital
      • Hutchinson, Minnesota, United States, 55350
        • Hutchinson Area Health Care
      • Mankato, Minnesota, United States, 56002
        • Immanuel-Saint Joseph Hospital-Mayo Health System
      • Maplewood, Minnesota, United States, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, United States, 55407
        • Virginia Piper Cancer Institute
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Medical Health Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Louis Park, Minnesota, United States, 55416
        • Metro-Minnesota CCOP
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Shakopee, Minnesota, United States, 55379
        • Saint Francis Regional Medical Center
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology and Hematology PA-Woodbury
    • Missouri
      • Saint Louis, Missouri, United States, 63131
        • Missouri Baptist Medical Center
      • Saint Louis, Missouri, United States, 63141
        • Center for Cancer Care and Research
      • Springfield, Missouri, United States, 65804
        • Saint John's Hospital
    • Montana
      • Billings, Montana, United States, 59101
        • Saint Vincent Healthcare
      • Billings, Montana, United States, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, United States, 59101
        • Montana Cancer Consortium CCOP
      • Billings, Montana, United States, 59102
        • Hematology-Oncology Centers of the Northern Rockies PC
      • Billings, Montana, United States, 59107-7000
        • Billings Clinic
      • Bozeman, Montana, United States, 59715
        • Bozeman Deaconess Cancer Center
      • Butte, Montana, United States, 59701
        • Saint James Community Hospital and Cancer Treatment Center
      • Great Falls, Montana, United States, 59405
        • Great Falls Clinic
      • Great Falls, Montana, United States, 59405
        • Berdeaux, Donald MD (UIA Investigator)
      • Havre, Montana, United States, 59501
        • Northern Montana Hospital
      • Helena, Montana, United States, 59601
        • Saint Peter's Community Hospital
      • Kalispell, Montana, United States, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, United States, 59901
        • Glacier Oncology PLLC
      • Kalispell, Montana, United States, 59901
        • Kalispell Medical Oncology
      • Missoula, Montana, United States, 59802
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, United States, 59804
        • Guardian Oncology and Center for Wellness
      • Missoula, Montana, United States, 59801
        • Community Medical Hospital
      • Missoula, Montana, United States, 59802
        • Montana Cancer Specialists
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Sanford Bismarck Medical Center
      • Bismarck, North Dakota, United States, 58501
        • Bismarck Cancer Center
      • Bismarck, North Dakota, United States, 58501
        • Mid Dakota Clinic
      • Bismarck, North Dakota, United States, 58501
        • Saint Alexius Medical Center
      • Fargo, North Dakota, United States, 58122
        • Sanford Clinic North-Fargo
      • Fargo, North Dakota, United States, 58122
        • Sanford Medical Center-Fargo
      • Grand Forks, North Dakota, United States, 58201
        • Altru Cancer Center
    • Ohio
      • Bowling Green, Ohio, United States, 43402
        • Toledo Clinic Cancer Centers-Bowling Green
      • Clyde, Ohio, United States, 43410
        • North Coast Cancer Care-Clyde
      • Dayton, Ohio, United States, 45406
        • Good Samaritan Hospital - Dayton
      • Dayton, Ohio, United States, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, United States, 45415
        • Samaritan North Health Center
      • Dayton, Ohio, United States, 45405
        • Grandview Hospital
      • Dayton, Ohio, United States, 45420
        • Dayton CCOP
      • Elyria, Ohio, United States, 44035
        • Hematology Oncology Center Incorporated
      • Findlay, Ohio, United States, 45840
        • Blanchard Valley Hospital
      • Franklin, Ohio, United States, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Greenville, Ohio, United States, 45331
        • Wayne Hospital
      • Kettering, Ohio, United States, 45429
        • Kettering Medical Center
      • Lima, Ohio, United States, 45804
        • Lima Memorial Hospital
      • Maumee, Ohio, United States, 43537
        • Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
      • Maumee, Ohio, United States, 43537
        • Saint Luke's Hospital
      • Maumee, Ohio, United States, 43537-1839
        • Toledo Clinic Cancer Centers-Maumee
      • Oregon, Ohio, United States, 43616
        • Saint Charles Hospital
      • Oregon, Ohio, United States, 43616
        • Toledo Clinic Cancer Centers-Oregon
      • Sandusky, Ohio, United States, 44870
        • North Coast Cancer Care
      • Sylvania, Ohio, United States, 43560
        • Flower Hospital
      • Tiffin, Ohio, United States, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, United States, 43608
        • Saint Vincent Mercy Medical Center
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic Cancer Centers-Toledo
      • Toledo, Ohio, United States, 43614
        • University of Toledo
      • Toledo, Ohio, United States, 43617
        • Toledo Community Hospital Oncology Program CCOP
      • Toledo, Ohio, United States, 43606
        • The Toledo Hospital/Toledo Children's Hospital
      • Toledo, Ohio, United States, 43623
        • Mercy Cancer Center at Saint Anne Mercy Hospital
      • Troy, Ohio, United States, 45373
        • Upper Valley Medical Center
      • Wauseon, Ohio, United States, 43567
        • Fulton County Health Center
      • Wilmington, Ohio, United States, 45177
        • Clinton Memorial Hospital
      • Xenia, Ohio, United States, 45385
        • Greene Memorial Hospital
    • Oregon
      • Portland, Oregon, United States, 97216
        • Adventist Medical Center
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-2001
        • Geisinger Medical Center
      • Hazleton, Pennsylvania, United States, 18201
        • Geisinger Medical Center-Cancer Center Hazelton
      • State College, Pennsylvania, United States, 16801
        • Geisinger Medical Group
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Geisinger Wyoming Valley
    • Virginia
      • Fredericksburg, Virginia, United States, 22401
        • Fredericksburg Oncology Inc
    • Wisconsin
      • Eau Claire, Wisconsin, United States, 54702
        • Midelfort Clinic-Clairemont Campus
      • Eau Claire, Wisconsin, United States, 54703
        • Mayo Clinic Health System Eau Claire Hospital - Luther Campus
      • Green Bay, Wisconsin, United States, 54301
        • Saint Vincent Hospital
      • Green Bay, Wisconsin, United States, 54303
        • Green Bay Oncology Limited at Saint Mary's Hospital
      • Green Bay, Wisconsin, United States, 54303
        • Saint Mary's Hospital
      • Green Bay, Wisconsin, United States, 54301-3526
        • Green Bay Oncology at Saint Vincent Hospital
      • Manitowoc, Wisconsin, United States, 54221
        • Holy Family Memorial Hospital
      • Marinette, Wisconsin, United States, 54143
        • Bay Area Medical Center
      • Oconto Falls, Wisconsin, United States, 54154
        • Green Bay Oncology - Oconto Falls
      • Sturgeon Bay, Wisconsin, United States, 54235
        • Green Bay Oncology - Sturgeon Bay
    • Wyoming
      • Sheridan, Wyoming, United States, 82801
        • Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of stage IV colorectal cancer (histologic proof is not required)
  • Measurable disease

    • Spiral CT scan required for both pre- and post-treatment tumor assessments of lesions measuring 1-2 cm
  • Progressive disease during or within 6 months of most recent prior chemotherapy regimen (bevacizumab, fluoropyrimidine, oxaliplatin, or irinotecan-based treatment) OR considered ineligible for standard therapy
  • Documentation of submission of tumor material for Kirsten Rat Sarcoma (KRAS) testing available
  • Prior anti-epidermal growth factor receptor (EGFR) antibody therapy (e.g., cetuximab or panitumumab) required for patients with wild-type KRAS tumor
  • No known brain metastasis

    • Patients with neurological symptoms must undergo a CT scan or MRI of the brain to exclude brain metastasis
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Life expectancy ≥ 6 months
  • Hemoglobin ≥ 9.0 g/dL
  • Absolute neutrophil count (ANC) ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • White blood cell count (WBC) ≥ 3,400/mm³
  • International normalized ratio (INR) < 1.5 (≤ 3.0 if on anti-coagulation therapy [e.g., warfarin or heparin])
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) ≤ 2.5 times ULN (≤ 5 times ULN if there is liver involvement)
  • Alkaline phosphatase ≤ 3 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Urine protein:creatinine ratio < 1 OR urine dipstick < 2+ OR urine protein < 1,000 mg by 24-hour urine collection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment (≥ 2 weeks after completion of treatment with sorafenib tosylate alone)
  • Willing to provide mandatory blood samples for translational research studies
  • Able to swallow whole pills
  • No inadequately controlled hypertension (i.e., systolic BP > 150 mm Hg or diastolic BP > 100 mm Hg on anti-hypertensive medications)
  • No prior hypertensive crisis or hypertensive encephalopathy
  • No myocardial infarction or unstable angina within the past 6 months
  • No congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
  • No thrombolic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months
  • No hemorrhage or bleeding event > grade 3 within the past 4 weeks
  • No evidence or history of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
  • No greater than normal risk of bleeding
  • No active or recent hemoptysis (≥ ½ teaspoon of bright red blood per episode) within the past 30 days
  • No concurrent uncontrolled illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia requiring anti-arrhythmic drugs
    • Psychiatric illness or social situations that would limit compliance with study requirements
  • No known HIV infection or chronic hepatitis B or C infection
  • No serious, non-healing wound, active ulcer, or untreated bone fracture

    • Patients with fractures secondary to metastatic disease are eligible after appropriate radiotherapy
  • No significant traumatic injury within the past 4 weeks
  • No known or suspected allergy or hypersensitivity to any component of bevacizumab, sorafenib tosylate, or their excipients or to any other agent given in the course of this study
  • No malabsorption problem
  • None of the following within the past 6 months:

    • Significant vascular disease (e.g., aortic aneurysm or aortic dissection)
    • Peripheral arterial thrombosis
    • Symptomatic peripheral vascular disease
    • Abdominal fistula
    • Gastrointestinal perforation
    • Intra-abdominal abscess
  • No other active malignancy within the past 3 years except non melanoma skin cancer or carcinoma in situ of the cervix

    • Prior malignancy allowed provided patient is not receiving other specific treatment for that malignancy (other than hormonal therapy)
  • No other concurrent investigational agent for this cancer
  • Prior radiotherapy allowed
  • No prior sorafenib tosylate
  • No prior discontinuation of bevacizumab due to adverse events
  • More than 4 weeks since prior and no concurrent participation in any other experimental drug study
  • More than 4 weeks since prior St. John's wort or rifampin
  • More than 4 weeks since prior and no concurrent major surgical procedure or open biopsy
  • More than 7 days since prior core biopsy or minor surgical procedure, including placement of a vascular access device
  • No concurrent anticoagulant, except low-dose warfarin or heparin for deep venous thrombosis prophylaxis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (sorafenib tosylate and bevacizumab)
Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies
Given IV
Other Names:
  • Avastin
  • anti-VEGF humanized monoclonal antibody
  • anti-VEGF monoclonal antibody
  • rhuMAb VEGF
Given orally
Other Names:
  • BAY 43-9006
  • BAY 43-9006 Tosylate Salt
  • BAY 54-9085
  • Nexavar
  • SFN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival Rate
Time Frame: At 3 months

The primary endpoint of this trial is progression free survival at 3 months. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be considered evaluable. Patients lost to follow-up before 3 months (e.g., progression, refusing further treatment, etc.) will be considered treatment failures. All eligible patients will be followed until death or a minimum of 3 years. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients.

Progression is defined as at least a 20% increase in the sum of longest liameter of target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.

At 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate
Time Frame: Up to 2 years
Simple frequency analysis will be conducted to see if response rate is related to prior treatment and the selected tumor biomarkers. Descriptive statistics will be used to investigate how prior treatment affects various other measures as well.
Up to 2 years
Overall Survival
Time Frame: Time from registration to death, assessed up to 2 years
The distribution of overall survival will be estimated using Kaplan-Meier methodology.
Time from registration to death, assessed up to 2 years
Feasibility of Study Treatment
Time Frame: Up to 2 years
Will be evaluated based on the number of patients who are able to> tolerate the regimen, how long they tolerate it and whether they elect to stop treatment.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Axel Grothey, MD, North Central Cancer Treatment Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

January 21, 2009

First Submitted That Met QC Criteria

January 21, 2009

First Posted (Estimate)

January 22, 2009

Study Record Updates

Last Update Posted (Actual)

September 6, 2017

Last Update Submitted That Met QC Criteria

August 7, 2017

Last Verified

August 1, 2017

More Information

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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