Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients With Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors

A Randomized Phase II Trial of Paclitaxel and Carboplatin vs. Bleomycin, Etoposide, and Cisplatin for Newly Diagnosed Advanced Stage and Recurrent Chemonaive Sex Cord-Stromal Tumors of the Ovary

Sponsors

Lead Sponsor: GOG Foundation

Collaborator: National Cancer Institute (NCI)

Source GOG Foundation
Brief Summary

This randomized phase II trial studies paclitaxel and carboplatin to see how well they work compared with bleomycin sulfate, etoposide phosphate, and cisplatin in treating patients with sex cord-ovarian stromal tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or has returned (recurrent). Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating sex cord-ovarian stromal tumors.

Detailed Description

PRIMARY OBJECTIVES: I. To assess the activity of paclitaxel and carboplatin with respect to progression free survival (using bleomycin, etoposide, and cisplatin [BEP] as a reference) for newly diagnosed advanced or recurrent chemonaive ovarian sex cord-stromal tumors. SECONDARY OBJECTIVES: I. To estimate the toxicity of paclitaxel and carboplatin, and bleomycin, etoposide, and cisplatin in this patient population. II. To estimate overall survival for paclitaxel and carboplatin relative to that of BEP. III. To evaluate response rate in the subset of patients with measurable disease. TERTIARY OBJECTIVES: I. To collect fixed and/or frozen tumor tissue for future translational research studies. II. To explore the utility of inhibin A and inhibin B as prognostic and predictive biomarkers for ovarian sex cord-stromal tumors and to examine changes in these markers with treatment. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive bleomycin sulfate IV on day 1 and etoposide phosphate* IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. NOTE: *Patients who have received prior radiotherapy receive etoposide phosphate on days 1-4. After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Overall Status Active, not recruiting
Start Date 2010-06-29
Completion Date 2022-06-21
Primary Completion Date 2020-06-26
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Progression-free survival (PFS) From start of treatment to time of progression or death, whichever occurs first, assessed up to 10 years
Secondary Outcome
Measure Time Frame
Tumor response rate Up to 10 years
Overall survival (OS) From start of treatment to time of death or the date of last contact, assessed up to 10 years
Enrollment 63
Condition
Intervention

Intervention Type: Biological

Intervention Name: Bleomycin Sulfate

Description: Given IV

Arm Group Label: Arm II (bleomycin sulfate, etoposide phosphate, cisplatin)

Intervention Type: Drug

Intervention Name: Carboplatin

Description: Given IV

Arm Group Label: Arm I (paclitaxel, carboplatin)

Intervention Type: Drug

Intervention Name: Cisplatin

Description: Given IV

Arm Group Label: Arm II (bleomycin sulfate, etoposide phosphate, cisplatin)

Intervention Type: Drug

Intervention Name: Etoposide Phosphate

Description: Given IV

Arm Group Label: Arm II (bleomycin sulfate, etoposide phosphate, cisplatin)

Other Name: Etopophos

Intervention Type: Other

Intervention Name: Laboratory Biomarker Analysis

Description: Correlative studies

Intervention Type: Drug

Intervention Name: Paclitaxel

Description: Given IV

Arm Group Label: Arm I (paclitaxel, carboplatin)

Eligibility

Criteria:

Inclusion Criteria: - Patients with histologically confirmed ovarian stromal tumor [granulosa cell tumor, ganulosa cell-theca cell tumor, Sertoli-Leydig cell tumor (androblastoma), steroid (lipid) cell tumor, gynandroblastoma, unclassified sex cord-stromal tumor, sex cord tumor with annular tubules] - Patients must have newly diagnosed, stage IIA - IV disease and must be entered within eight weeks from surgery; they may have either measurable residual disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria, or they may have no measurable residual disease; OR, they must have biopsy-proven recurrent disease of any stage and have never received cytotoxic chemotherapy - Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2 - Patients of childbearing potential must have a negative serum pregnancy test and must agree to practice an effective means of birth control - Patients in the measureable disease cohort must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy - Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 - Platelet greater than or equal to 100,000/mcl - Creatinine no greater than the institutional upper limits of normal - Bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (CTCAE grade 1) - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) less than or equal to 3.0 x ULN (CTCAE grade 1) - Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE grade 1) - Neuropathy (sensory and motor) less than or equal to CTCAE grade 1 - No signs of clinically significant hearing loss - Patients must have signed an approved informed consent and authorization permitting release of personal health information - Patients must have pulmonary function sufficient to receive bleomycin, with normal lung expansion, absence of crackles on auscultation, and normal carbon monoxide diffusion (DLCO), defined as greater than 80% predicted - Patients with a history of hypersensitivity reactions to prior chemotherapy administered for previous cancer diagnoses are eligible to participate in the study, unless the hypersensitivity reaction consisted of anaphylaxis not amenable to desensitization - Recovery from effects of recent surgery, radiotherapy, or chemotherapy - Patients must be entered within 8 weeks after surgery performed for either 1) initial diagnosis, staging, and/or cytoreduction, or 2) (if done) management of recurrent disease in a chemonaive patient - Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted Exclusion Criteria: - Patients who have received any prior cytotoxic chemotherapy or biologics for sex cord-stromal tumors (SCSTs) - Patients with apparent stage I disease who have not undergone a staging procedure - Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years - Woman who are pregnant or breastfeeding - Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; the investigator can consult the study chair or study co-chairs for uncertainty in this regard

Gender:

Female

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Jubilee Brown Principal Investigator NRG Oncology
Location
Facility:
Alaska Breast Care and Surgery LLC | Anchorage, Alaska, 99508, United States
Alaska Women's Cancer Care | Anchorage, Alaska, 99508, United States
Anchorage Oncology Centre | Anchorage, Alaska, 99508, United States
Katmai Oncology Group | Anchorage, Alaska, 99508, United States
Providence Alaska Medical Center | Anchorage, Alaska, 99508, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank, California, 91505, United States
Olive View-University of California Los Angeles Medical Center | Sylmar, California, 91342, United States
University of Colorado Hospital | Aurora, Colorado, 80045, United States
Hartford Hospital | Hartford, Connecticut, 06102, United States
The Hospital of Central Connecticut | New Britain, Connecticut, 06050, United States
Sibley Memorial Hospital | Washington, District of Columbia, 20016, United States
Northside Hospital | Atlanta, Georgia, 30342, United States
Augusta University Medical Center | Augusta, Georgia, 30912, United States
Northside Hospital-Forsyth | Cumming, Georgia, 30041, United States
Central Georgia Gynecologic Oncology | Macon, Georgia, 31201, United States
Memorial Health University Medical Center | Savannah, Georgia, 31404, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah, Georgia, 31405, United States
Kootenai Health - Coeur d'Alene | Coeur d'Alene, Idaho, 83814, United States
Kootenai Clinic Cancer Services - Post Falls | Post Falls, Idaho, 83854, United States
Kootenai Cancer Clinic | Sandpoint, Idaho, 83864, United States
Saint Joseph Medical Center | Bloomington, Illinois, 61701, United States
Illinois CancerCare-Bloomington | Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton | Canton, Illinois, 61520, United States
Memorial Hospital of Carbondale | Carbondale, Illinois, 62902, United States
SIH Cancer Institute | Carterville, Illinois, 62918, United States
Illinois CancerCare-Carthage | Carthage, Illinois, 62321, United States
Centralia Oncology Clinic | Centralia, Illinois, 62801, United States
University of Chicago Comprehensive Cancer Center | Chicago, Illinois, 60637, United States
Cancer Care Specialists of Illinois - Decatur | Decatur, Illinois, 62526, United States
Decatur Memorial Hospital | Decatur, Illinois, 62526, United States
Crossroads Cancer Center | Effingham, Illinois, 62401, United States
Illinois CancerCare-Eureka | Eureka, Illinois, 61530, United States
NorthShore University HealthSystem-Evanston Hospital | Evanston, Illinois, 60201, United States
Illinois CancerCare-Galesburg | Galesburg, Illinois, 61401, United States
Western Illinois Cancer Treatment Center | Galesburg, Illinois, 61401, United States
NorthShore University HealthSystem-Glenbrook Hospital | Glenview, Illinois, 60026, United States
NorthShore University HealthSystem-Highland Park Hospital | Highland Park, Illinois, 60035, United States
Sudarshan K Sharma MD Limited-Gynecologic Oncology | Hinsdale, Illinois, 60521, United States
Illinois CancerCare-Kewanee Clinic | Kewanee, Illinois, 61443, United States
Illinois CancerCare-Macomb | Macomb, Illinois, 61455, United States
Good Samaritan Regional Health Center | Mount Vernon, Illinois, 62864, United States
UC Comprehensive Cancer Center at Silver Cross | New Lenox, Illinois, 60451, United States
Cancer Care Center of O'Fallon | O'Fallon, Illinois, 62269, United States
Illinois CancerCare-Ottawa Clinic | Ottawa, Illinois, 61350, United States
Radiation Oncology of Northern Illinois | Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin | Pekin, Illinois, 61554, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center | Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria | Peoria, Illinois, 61615, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center | Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois | Peoria, Illinois, 61636, United States
OSF Saint Francis Medical Center | Peoria, Illinois, 61637, United States
Illinois CancerCare-Peru | Peru, Illinois, 61354, United States
Valley Radiation Oncology | Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton | Princeton, Illinois, 61356, United States
Central Illinois Hematology Oncology Center | Springfield, Illinois, 62702, United States
Southern Illinois University School of Medicine | Springfield, Illinois, 62702, United States
Springfield Clinic | Springfield, Illinois, 62702, United States
Memorial Medical Center | Springfield, Illinois, 62781, United States
Southwest Illinois Health Services LLP | Swansea, Illinois, 62226, United States
Saint Vincent Hospital and Health Care Center | Indianapolis, Indiana, 46260, United States
University of Iowa/Holden Comprehensive Cancer Center | Iowa City, Iowa, 52242, United States
Coffeyville Regional Medical Center | Coffeyville, Kansas, 67337, United States
University of Kansas Clinical Research Center | Fairway, Kansas, 66205, United States
HaysMed University of Kansas Health System | Hays, Kansas, 67601, United States
University of Kansas Cancer Center | Kansas City, Kansas, 66160, United States
Olathe Health Cancer Center | Olathe, Kansas, 66061, United States
Ascension Via Christi - Pittsburg | Pittsburg, Kansas, 66762, United States
Salina Regional Health Center | Salina, Kansas, 67401, United States
University of Kansas Health System Saint Francis Campus | Topeka, Kansas, 66606, United States
University of Kansas Hospital-Westwood Cancer Center | Westwood, Kansas, 66205, United States
University of Kentucky/Markey Cancer Center | Lexington, Kentucky, 40536, United States
University Medical Center New Orleans | New Orleans, Louisiana, 70112, United States
Sinai Hospital of Baltimore | Baltimore, Maryland, 21215, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute | Baltimore, Maryland, 21237, United States
Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore, Maryland, 21287, United States
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan, 48109, United States
Henry Ford Hospital | Detroit, Michigan, 48202, United States
Green Bay Oncology - Escanaba | Escanaba, Michigan, 49829, United States
Green Bay Oncology - Iron Mountain | Iron Mountain, Michigan, 49801, United States
Bronson Methodist Hospital | Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center | Kalamazoo, Michigan, 49007, United States
Borgess Medical Center | Kalamazoo, Michigan, 49048, United States
William Beaumont Hospital-Royal Oak | Royal Oak, Michigan, 48073, United States
William Beaumont Hospital - Troy | Troy, Michigan, 48085, United States
University of Mississippi Medical Center | Jackson, Mississippi, 39216, United States
Central Care Cancer Center - Bolivar | Bolivar, Missouri, 65613, United States
Parkland Health Center-Bonne Terre | Bonne Terre, Missouri, 63628, United States
Cox Cancer Center Branson | Branson, Missouri, 65616, United States
Saint Francis Medical Center | Cape Girardeau, Missouri, 63703, United States
Southeast Cancer Center | Cape Girardeau, Missouri, 63703, United States
Capital Region Southwest Campus | Jefferson City, Missouri, 65109, United States
Freeman Health System | Joplin, Missouri, 64804, United States
Mercy Hospital Joplin | Joplin, Missouri, 64804, United States
Truman Medical Centers | Kansas City, Missouri, 64108, United States
University of Kansas Cancer Center - North | Kansas City, Missouri, 64154, United States
University of Kansas Cancer Center at North Kansas City Hospital | North Kansas City, Missouri, 64116, United States
Delbert Day Cancer Institute at PCRMC | Rolla, Missouri, 65401, United States
Mercy Clinic-Rolla-Cancer and Hematology | Rolla, Missouri, 65401, United States
Saint Louis Cancer and Breast Institute-South City | Saint Louis, Missouri, 63109, United States
Washington University School of Medicine | Saint Louis, Missouri, 63110, United States
Missouri Baptist Medical Center | Saint Louis, Missouri, 63131, United States
Mercy Hospital Saint Louis | Saint Louis, Missouri, 63141, United States
Sainte Genevieve County Memorial Hospital | Sainte Genevieve, Missouri, 63670, United States
Mercy Hospital Springfield | Springfield, Missouri, 65804, United States
CoxHealth South Hospital | Springfield, Missouri, 65807, United States
Missouri Baptist Sullivan Hospital | Sullivan, Missouri, 63080, United States
Missouri Baptist Outpatient Center-Sunset Hills | Sunset Hills, Missouri, 63127, United States
Community Hospital of Anaconda | Anaconda, Montana, 59711, United States
Billings Clinic Cancer Center | Billings, Montana, 59101, United States
Saint Vincent Healthcare | Billings, Montana, 59101, United States
Bozeman Deaconess Hospital | Bozeman, Montana, 59715, United States
Saint James Community Hospital and Cancer Treatment Center | Butte, Montana, 59701, United States
Benefis Healthcare- Sletten Cancer Institute | Great Falls, Montana, 59405, United States
Great Falls Clinic | Great Falls, Montana, 59405, United States
Saint Peter's Community Hospital | Helena, Montana, 59601, United States
Kalispell Regional Medical Center | Kalispell, Montana, 59901, United States
Saint Patrick Hospital - Community Hospital | Missoula, Montana, 59802, United States
Community Medical Hospital | Missoula, Montana, 59804, United States
Nebraska Methodist Hospital | Omaha, Nebraska, 68114, United States
Women's Cancer Center of Nevada | Las Vegas, Nevada, 89169, United States
Memorial Sloan Kettering Basking Ridge | Basking Ridge, New Jersey, 07920, United States
University of New Mexico Cancer Center | Albuquerque, New Mexico, 87102, United States
Southwest Gynecologic Oncology Associates Inc | Albuquerque, New Mexico, 87106, United States
Memorial Sloan Kettering Commack | Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester | Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center | New York, New York, 10065, United States
Memorial Sloan Kettering Sleepy Hollow | Sleepy Hollow, New York, 10591, United States
Stony Brook University Medical Center | Stony Brook, New York, 11794, United States
Memorial Sloan Kettering Nassau | Uniondale, New York, 11553, United States
UNC Lineberger Comprehensive Cancer Center | Chapel Hill, North Carolina, 27599, United States
Carolinas Medical Center/Levine Cancer Institute | Charlotte, North Carolina, 28203, United States
Atrium Health Cabarrus/LCI-Concord | Concord, North Carolina, 28025, United States
Duke University Medical Center | Durham, North Carolina, 27710, United States
Wake Forest University Health Sciences | Winston-Salem, North Carolina, 27157, United States
Summa Health System - Akron Campus | Akron, Ohio, 44304, United States
Strecker Cancer Center-Belpre | Belpre, Ohio, 45714, United States
Adena Regional Medical Center | Chillicothe, Ohio, 45601, United States
Case Western Reserve University | Cleveland, Ohio, 44106, United States
MetroHealth Medical Center | Cleveland, Ohio, 44109, United States
Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation | Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center | Columbus, Ohio, 43210, United States
Mount Carmel East Hospital | Columbus, Ohio, 43213, United States
Columbus Oncology and Hematology Associates Inc | Columbus, Ohio, 43214, United States
Riverside Methodist Hospital | Columbus, Ohio, 43214, United States
Grant Medical Center | Columbus, Ohio, 43215, United States
The Mark H Zangmeister Center | Columbus, Ohio, 43219, United States
Mount Carmel Health Center West | Columbus, Ohio, 43222, United States
Doctors Hospital | Columbus, Ohio, 43228, United States
Delaware Health Center-Grady Cancer Center | Delaware, Ohio, 43015, United States
Delaware Radiation Oncology | Delaware, Ohio, 43015, United States
Grady Memorial Hospital | Delaware, Ohio, 43015, United States
Dublin Methodist Hospital | Dublin, Ohio, 43016, United States
Central Ohio Breast and Endocrine Surgery | Gahanna, Ohio, 43230, United States
Mount Carmel Grove City Hospital | Grove City, Ohio, 43123, United States
Fairfield Medical Center | Lancaster, Ohio, 43130, United States
Lancaster Radiation Oncology | Lancaster, Ohio, 43130, United States
OhioHealth Mansfield Hospital | Mansfield, Ohio, 44903, United States
Marietta Memorial Hospital | Marietta, Ohio, 45750, United States
OhioHealth Marion General Hospital | Marion, Ohio, 43302, United States
Hillcrest Hospital Cancer Center | Mayfield Heights, Ohio, 44124, United States
UH Seidman Cancer Center at Lake Health Mentor Campus | Mentor, Ohio, 44060, United States
Knox Community Hospital | Mount Vernon, Ohio, 43050, United States
Licking Memorial Hospital | Newark, Ohio, 43055, United States
Newark Radiation Oncology | Newark, Ohio, 43055, United States
Southern Ohio Medical Center | Portsmouth, Ohio, 45662, United States
Springfield Regional Medical Center | Springfield, Ohio, 45505, United States
Saint Ann's Hospital | Westerville, Ohio, 43081, United States
Genesis Healthcare System Cancer Care Center | Zanesville, Ohio, 43701, United States
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa | Tulsa, Oklahoma, 74146, United States
Clackamas Radiation Oncology Center | Clackamas, Oregon, 97015, United States
Providence Cancer Institute Clackamas Clinic | Clackamas, Oregon, 97015, United States
Providence Newberg Medical Center | Newberg, Oregon, 97132, United States
Providence Willamette Falls Medical Center | Oregon City, Oregon, 97045, United States
Providence Portland Medical Center | Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center | Portland, Oregon, 97225, United States
Abington Memorial Hospital | Abington, Pennsylvania, 19001, United States
Lehigh Valley Hospital-Cedar Crest | Allentown, Pennsylvania, 18103, United States
Geisinger Medical Center | Danville, Pennsylvania, 17822, United States
Geisinger Medical Center-Cancer Center Hazleton | Hazleton, Pennsylvania, 18201, United States
Jefferson Hospital | Jefferson Hills, Pennsylvania, 15025, United States
Geisinger Medical Oncology-Lewisburg | Lewisburg, Pennsylvania, 17837, United States
Lewistown Hospital | Lewistown, Pennsylvania, 17044, United States
Forbes Hospital | Monroeville, Pennsylvania, 15146, United States
Fox Chase Cancer Center | Philadelphia, Pennsylvania, 19111, United States
Temple University Hospital | Philadelphia, Pennsylvania, 19140, United States
Allegheny General Hospital | Pittsburgh, Pennsylvania, 15212, United States
West Penn Hospital | Pittsburgh, Pennsylvania, 15224, United States
Geisinger Cancer Services-Pottsville | Pottsville, Pennsylvania, 17901, United States
Community Medical Center | Scranton, Pennsylvania, 18510, United States
Geisinger Medical Oncology-Selinsgrove | Selinsgrove, Pennsylvania, 17870, United States
Geisinger Medical Group | State College, Pennsylvania, 16801, United States
Wexford Health and Wellness Pavilion | Wexford, Pennsylvania, 15090, United States
Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre, Pennsylvania, 18711, United States
Women and Infants Hospital | Providence, Rhode Island, 02905, United States
Sanford Cancer Center Oncology Clinic | Sioux Falls, South Dakota, 57104, United States
Avera Cancer Institute | Sioux Falls, South Dakota, 57105, United States
Sanford USD Medical Center - Sioux Falls | Sioux Falls, South Dakota, 57117-5134, United States
Parkland Memorial Hospital | Dallas, Texas, 75235, United States
UT Southwestern/Simmons Cancer Center-Dallas | Dallas, Texas, 75390, United States
M D Anderson Cancer Center | Houston, Texas, 77030, United States
PeaceHealth Saint John Medical Center | Longview, Washington, 98632, United States
PeaceHealth Southwest Medical Center | Vancouver, Washington, 98664, United States
Green Bay Oncology at Saint Vincent Hospital | Green Bay, Wisconsin, 54301-3526, United States
Saint Vincent Hospital Cancer Center Green Bay | Green Bay, Wisconsin, 54301, United States
Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay, Wisconsin, 54303, United States
Saint Vincent Hospital Cancer Center at Saint Mary's | Green Bay, Wisconsin, 54303, United States
Aurora BayCare Medical Center | Green Bay, Wisconsin, 54311, United States
Holy Family Memorial Hospital | Manitowoc, Wisconsin, 54221, United States
Bay Area Medical Center | Marinette, Wisconsin, 54143, United States
Aurora Saint Luke's Medical Center | Milwaukee, Wisconsin, 53215, United States
Saint Vincent Hospital Cancer Center at Oconto Falls | Oconto Falls, Wisconsin, 54154, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay | Sturgeon Bay, Wisconsin, 54235-1495, United States
Green Bay Oncology - Sturgeon Bay | Sturgeon Bay, Wisconsin, 54235, United States
Aurora West Allis Medical Center | West Allis, Wisconsin, 53227, United States
Big Horn Basin Cancer Center | Cody, Wyoming, 82414, United States
Billings Clinic-Cody | Cody, Wyoming, 82414, United States
Welch Cancer Center | Sheridan, Wyoming, 82801, United States
Location Countries

United States

Verification Date

2021-06-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Arm I (paclitaxel, carboplatin)

Type: Experimental

Description: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Label: Arm II (bleomycin sulfate, etoposide phosphate, cisplatin)

Type: Experimental

Description: Patients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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