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.
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.
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
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There are 190 Locations for this study
Anchorage Alaska, 99508, United States
Anchorage Alaska, 99508, United States
Anchorage Alaska, 99508, United States
Anchorage Alaska, 99508, United States
Anchorage Alaska, 99508, United States
Burbank California, 91505, United States
Sylmar California, 91342, United States
Aurora Colorado, 80045, United States
Hartford Connecticut, 06102, United States
New Britain Connecticut, 06050, United States
Washington District of Columbia, 20016, United States
Atlanta Georgia, 30342, United States
Augusta Georgia, 30912, United States
Cumming Georgia, 30041, United States
Macon Georgia, 31201, United States
Savannah Georgia, 31404, United States
Savannah Georgia, 31405, United States
Coeur d'Alene Idaho, 83814, United States
Post Falls Idaho, 83854, United States
Sandpoint Idaho, 83864, United States
Bloomington Illinois, 61701, United States
Bloomington Illinois, 61704, United States
Canton Illinois, 61520, United States
Carbondale Illinois, 62902, United States
Carterville Illinois, 62918, United States
Carthage Illinois, 62321, United States
Centralia Illinois, 62801, United States
Chicago Illinois, 60637, United States
Decatur Illinois, 62526, United States
Decatur Illinois, 62526, United States
Effingham Illinois, 62401, United States
Eureka Illinois, 61530, United States
Evanston Illinois, 60201, United States
Galesburg Illinois, 61401, United States
Galesburg Illinois, 61401, United States
Glenview Illinois, 60026, United States
Highland Park Illinois, 60035, United States
Hinsdale Illinois, 60521, United States
Kewanee Illinois, 61443, United States
Macomb Illinois, 61455, United States
Mount Vernon Illinois, 62864, United States
New Lenox Illinois, 60451, United States
O'Fallon Illinois, 62269, United States
Ottawa Illinois, 61350, United States
Ottawa Illinois, 61350, United States
Pekin Illinois, 61554, United States
Pekin Illinois, 61554, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61636, United States
Peoria Illinois, 61637, United States
Peru Illinois, 61354, United States
Peru Illinois, 61354, United States
Princeton Illinois, 61356, United States
Springfield Illinois, 62702, United States
Springfield Illinois, 62702, United States
Springfield Illinois, 62702, United States
Springfield Illinois, 62781, United States
Swansea Illinois, 62226, United States
Indianapolis Indiana, 46260, United States
Iowa City Iowa, 52242, United States
Coffeyville Kansas, 67337, United States
Fairway Kansas, 66205, United States
Hays Kansas, 67601, United States
Kansas City Kansas, 66160, United States
Olathe Kansas, 66061, United States
Pittsburg Kansas, 66762, United States
Salina Kansas, 67401, United States
Topeka Kansas, 66606, United States
Westwood Kansas, 66205, United States
Lexington Kentucky, 40536, United States
New Orleans Louisiana, 70112, United States
Baltimore Maryland, 21215, United States
Baltimore Maryland, 21237, United States
Baltimore Maryland, 21287, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48202, United States
Escanaba Michigan, 49829, United States
Iron Mountain Michigan, 49801, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49048, United States
Royal Oak Michigan, 48073, United States
Troy Michigan, 48085, United States
Jackson Mississippi, 39216, United States
Bolivar Missouri, 65613, United States
Bonne Terre Missouri, 63628, United States
Branson Missouri, 65616, United States
Cape Girardeau Missouri, 63703, United States
Cape Girardeau Missouri, 63703, United States
Jefferson City Missouri, 65109, United States
Joplin Missouri, 64804, United States
Joplin Missouri, 64804, United States
Kansas City Missouri, 64108, United States
Kansas City Missouri, 64154, United States
North Kansas City Missouri, 64116, United States
Rolla Missouri, 65401, United States
Rolla Missouri, 65401, United States
Saint Louis Missouri, 63109, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63131, United States
Saint Louis Missouri, 63141, United States
Sainte Genevieve Missouri, 63670, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
Sullivan Missouri, 63080, United States
Sunset Hills Missouri, 63127, United States
Anaconda Montana, 59711, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Bozeman Montana, 59715, United States
Butte Montana, 59701, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Helena Montana, 59601, United States
Kalispell Montana, 59901, United States
Missoula Montana, 59802, United States
Missoula Montana, 59804, United States
Omaha Nebraska, 68114, United States
Las Vegas Nevada, 89169, United States
Basking Ridge New Jersey, 07920, United States
Albuquerque New Mexico, 87102, United States
Albuquerque New Mexico, 87106, United States
Commack New York, 11725, United States
Harrison New York, 10604, United States
New York New York, 10065, United States
Sleepy Hollow New York, 10591, United States
Stony Brook New York, 11794, United States
Uniondale New York, 11553, United States
Chapel Hill North Carolina, 27599, United States
Charlotte North Carolina, 28203, United States
Concord North Carolina, 28025, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27157, United States
Akron Ohio, 44304, United States
Belpre Ohio, 45714, United States
Chillicothe Ohio, 45601, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44109, United States
Cleveland Ohio, 44111, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43213, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43219, United States
Columbus Ohio, 43222, United States
Columbus Ohio, 43228, United States
Delaware Ohio, 43015, United States
Delaware Ohio, 43015, United States
Delaware Ohio, 43015, United States
Dublin Ohio, 43016, United States
Gahanna Ohio, 43230, United States
Grove City Ohio, 43123, United States
Lancaster Ohio, 43130, United States
Lancaster Ohio, 43130, United States
Mansfield Ohio, 44903, United States
Marietta Ohio, 45750, United States
Marion Ohio, 43302, United States
Mayfield Heights Ohio, 44124, United States
Mentor Ohio, 44060, United States
Mount Vernon Ohio, 43050, United States
Newark Ohio, 43055, United States
Newark Ohio, 43055, United States
Portsmouth Ohio, 45662, United States
Springfield Ohio, 45505, United States
Westerville Ohio, 43081, United States
Zanesville Ohio, 43701, United States
Oklahoma City Oklahoma, 73104, United States
Tulsa Oklahoma, 74146, United States
Clackamas Oregon, 97015, United States
Clackamas Oregon, 97015, United States
Newberg Oregon, 97132, United States
Oregon City Oregon, 97045, United States
Portland Oregon, 97213, United States
Portland Oregon, 97225, United States
Abington Pennsylvania, 19001, United States
Allentown Pennsylvania, 18103, United States
Danville Pennsylvania, 17822, United States
Hazleton Pennsylvania, 18201, United States
Jefferson Hills Pennsylvania, 15025, United States
Lewisburg Pennsylvania, 17837, United States
Lewistown Pennsylvania, 17044, United States
Monroeville Pennsylvania, 15146, United States
Philadelphia Pennsylvania, 19111, United States
Philadelphia Pennsylvania, 19140, United States
Pittsburgh Pennsylvania, 15212, United States
Pittsburgh Pennsylvania, 15224, United States
Pottsville Pennsylvania, 17901, United States
Scranton Pennsylvania, 18510, United States
Selinsgrove Pennsylvania, 17870, United States
State College Pennsylvania, 16801, United States
Wexford Pennsylvania, 15090, United States
Wilkes-Barre Pennsylvania, 18711, United States
Providence Rhode Island, 02905, United States
Sioux Falls South Dakota, 57104, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57117, United States
Dallas Texas, 75235, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Longview Washington, 98632, United States
Vancouver Washington, 98664, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54311, United States
Manitowoc Wisconsin, 54221, United States
Marinette Wisconsin, 54143, United States
Milwaukee Wisconsin, 53215, United States
Oconto Falls Wisconsin, 54154, United States
Sturgeon Bay Wisconsin, 54235, United States
Sturgeon Bay Wisconsin, 54235, United States
West Allis Wisconsin, 53227, United States
Cody Wyoming, 82414, United States
Cody Wyoming, 82414, United States
Sheridan Wyoming, 82801, United States
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