Ovarian Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

63

Study ID:

NCT01042522

Recruitment Status:

Active, not recruiting

Sponsor:

GOG Foundation

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There are 190 Locations for this study

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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
Jefferson Abington 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, 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, 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, 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

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

63

Study ID:

NCT01042522

Recruitment Status:

Active, not recruiting

Sponsor:


GOG Foundation

How clear is this clinincal trial information?

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