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NCT01042522 Clinical Trial

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

Ovarian Granulosa Cell Tumor Clinical Trial

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01042522
Other study ID # GOG-0264
Secondary ID NCI-2011-02000CD
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date February 8, 2010
Est. completion date November 2, 2022

Study information
Verified date December 2021
Source GOG Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 63
Est. completion date November 2, 2022
Est. primary completion date June 12, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• Bleomycin Sulfate
Given IV
Drug:
• Carboplatin
Given IV
• Cisplatin
Given IV
• Etoposide Phosphate
Given IV
Other:
• Laboratory Biomarker Analysis
Correlative studies
Drug:
• Paclitaxel
Given IV

Locations
Country Name City State
United States Jefferson Abington Hospital Abington Pennsylvania
United States Summa Health System - Akron Campus Akron Ohio
United States Southwest Gynecologic Oncology Associates Inc Albuquerque New Mexico
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Community Hospital of Anaconda Anaconda Montana
United States Alaska Breast Care and Surgery LLC Anchorage Alaska
United States Alaska Women's Cancer Care Anchorage Alaska
United States Anchorage Oncology Centre Anchorage Alaska
United States Katmai Oncology Group Anchorage Alaska
United States Providence Alaska Medical Center Anchorage Alaska
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Northside Hospital Atlanta Georgia
United States Augusta University Medical Center Augusta Georgia
United States University of Colorado Hospital Aurora Colorado
United States Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland
United States MedStar Franklin Square Medical Center/Weinberg Cancer Institute Baltimore Maryland
United States Sinai Hospital of Baltimore Baltimore Maryland
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Strecker Cancer Center-Belpre Belpre Ohio
United States Billings Clinic Cancer Center Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Joseph Medical Center Bloomington Illinois
United States Central Care Cancer Center - Bolivar Bolivar Missouri
United States Parkland Health Center-Bonne Terre Bonne Terre Missouri
United States Bozeman Deaconess Hospital Bozeman Montana
United States Cox Cancer Center Branson Branson Missouri
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States SIH Cancer Institute Carterville Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Centralia Oncology Clinic Centralia Illinois
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States Providence Cancer Institute Clackamas Clinic Clackamas Oregon
United States Case Western Reserve University Cleveland Ohio
United States Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States MetroHealth Medical Center Cleveland Ohio
United States Big Horn Basin Cancer Center Cody Wyoming
United States Billings Clinic-Cody Cody Wyoming
United States Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho
United States Coffeyville Regional Medical Center Coffeyville Kansas
United States Columbus Oncology and Hematology Associates Inc Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States Mount Carmel East Hospital Columbus Ohio
United States Mount Carmel Health Center West Columbus Ohio
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States The Mark H Zangmeister Center Columbus Ohio
United States Memorial Sloan Kettering Commack Commack New York
United States Atrium Health Cabarrus/LCI-Concord Concord North Carolina
United States Northside Hospital-Forsyth Cumming Georgia
United States Parkland Memorial Hospital Dallas Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Geisinger Medical Center Danville Pennsylvania
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Delaware Health Center-Grady Cancer Center Delaware Ohio
United States Delaware Radiation Oncology Delaware Ohio
United States Grady Memorial Hospital Delaware Ohio
United States Henry Ford Hospital Detroit Michigan
United States Dublin Methodist Hospital Dublin Ohio
United States Duke University Medical Center Durham North Carolina
United States Crossroads Cancer Center Effingham Illinois
United States Green Bay Oncology - Escanaba Escanaba Michigan
United States Illinois CancerCare-Eureka Eureka Illinois
United States NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
United States University of Kansas Clinical Research Center Fairway Kansas
United States Central Ohio Breast and Endocrine Surgery Gahanna Ohio
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States Aurora BayCare Medical Center Green Bay Wisconsin
United States Green Bay Oncology at Saint Vincent Hospital Green Bay Wisconsin
United States Green Bay Oncology Limited at Saint Mary's Hospital Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States Mount Carmel Grove City Hospital Grove City Ohio
United States Memorial Sloan Kettering Westchester Harrison New York
United States Hartford Hospital Hartford Connecticut
United States HaysMed University of Kansas Health System Hays Kansas
United States Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania
United States Saint Peter's Community Hospital Helena Montana
United States NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois
United States Sudarshan K Sharma MD Limited-Gynecologic Oncology Hinsdale Illinois
United States M D Anderson Cancer Center Houston Texas
United States Saint Vincent Hospital and Health Care Center Indianapolis Indiana
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States Green Bay Oncology - Iron Mountain Iron Mountain Michigan
United States University of Mississippi Medical Center Jackson Mississippi
United States Capital Region Southwest Campus Jefferson City Missouri
United States Jefferson Hospital Jefferson Hills Pennsylvania
United States Freeman Health System Joplin Missouri
United States Mercy Hospital Joplin Joplin Missouri
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Kalispell Regional Medical Center Kalispell Montana
United States Truman Medical Centers Kansas City Missouri
United States University of Kansas Cancer Center Kansas City Kansas
United States University of Kansas Cancer Center - North Kansas City Missouri
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Fairfield Medical Center Lancaster Ohio
United States Lancaster Radiation Oncology Lancaster Ohio
United States Women's Cancer Center of Nevada Las Vegas Nevada
United States Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania
United States Lewistown Hospital Lewistown Pennsylvania
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States PeaceHealth Saint John Medical Center Longview Washington
United States Illinois CancerCare-Macomb Macomb Illinois
United States Central Georgia Gynecologic Oncology Macon Georgia
United States Holy Family Memorial Hospital Manitowoc Wisconsin
United States OhioHealth Mansfield Hospital Mansfield Ohio
United States Marietta Memorial Hospital Marietta Ohio
United States Bay Area Medical Center Marinette Wisconsin
United States OhioHealth Marion General Hospital Marion Ohio
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Community Medical Hospital Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Forbes Hospital Monroeville Pennsylvania
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Knox Community Hospital Mount Vernon Ohio
United States The Hospital of Central Connecticut New Britain Connecticut
United States UC Comprehensive Cancer Center at Silver Cross New Lenox Illinois
United States University Medical Center New Orleans New Orleans Louisiana
United States Memorial Sloan Kettering Cancer Center New York New York
United States Licking Memorial Hospital Newark Ohio
United States Newark Radiation Oncology Newark Ohio
United States Providence Newberg Medical Center Newberg Oregon
United States University of Kansas Cancer Center at North Kansas City Hospital North Kansas City Missouri
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls Wisconsin
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Olathe Health Cancer Center Olathe Kansas
United States Nebraska Methodist Hospital Omaha Nebraska
United States Providence Willamette Falls Medical Center Oregon City Oregon
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Radiation Oncology of Northern Illinois Ottawa Illinois
United States Illinois CancerCare-Pekin Pekin Illinois
United States OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Temple University Hospital Philadelphia Pennsylvania
United States Ascension Via Christi - Pittsburg Pittsburg Kansas
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States West Penn Hospital Pittsburgh Pennsylvania
United States Providence Portland Medical Center Portland Oregon
United States Providence Saint Vincent Medical Center Portland Oregon
United States Southern Ohio Medical Center Portsmouth Ohio
United States Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho
United States Geisinger Cancer Services-Pottsville Pottsville Pennsylvania
United States Illinois CancerCare-Princeton Princeton Illinois
United States Women and Infants Hospital Providence Rhode Island
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Salina Regional Health Center Salina Kansas
United States Kootenai Cancer Clinic Sandpoint Idaho
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Memorial Health University Medical Center Savannah Georgia
United States Community Medical Center Scranton Pennsylvania
United States Geisinger Medical Oncology-Selinsgrove Selinsgrove Pennsylvania
United States Welch Cancer Center Sheridan Wyoming
United States Avera Cancer Institute Sioux Falls South Dakota
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Memorial Sloan Kettering Sleepy Hollow Sleepy Hollow New York
United States Central Illinois Hematology Oncology Center Springfield Illinois
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Springfield Regional Medical Center Springfield Ohio
United States Geisinger Medical Group State College Pennsylvania
United States Stony Brook University Medical Center Stony Brook New York
United States Green Bay Oncology - Sturgeon Bay Sturgeon Bay Wisconsin
United States Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay Wisconsin
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri
United States Southwest Illinois Health Services LLP Swansea Illinois
United States Olive View-University of California Los Angeles Medical Center Sylmar California
United States University of Kansas Health System Saint Francis Campus Topeka Kansas
United States William Beaumont Hospital - Troy Troy Michigan
United States Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma
United States Memorial Sloan Kettering Nassau Uniondale New York
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States Sibley Memorial Hospital Washington District of Columbia
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Saint Ann's Hospital Westerville Ohio
United States University of Kansas Hospital-Westwood Cancer Center Westwood Kansas
United States Wexford Health and Wellness Pavilion Wexford Pennsylvania
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio

Sponsors (2)
Lead Sponsor Collaborator
GOG Foundation National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Change in Inhibin A and Inhibin B Levels Pre-treatment levels of inhibin A and inhibin B will be examined in relation to OS and PFS in Cox proportional hazards models. Changes from baseline in inhibin levels will be compared between treatment groups using mixed effects models accounting for the longitudinal nature of the data. The repeated measures of inhibin will also be explored versus overall survival and PFS using time-dependent covariates in Cox proportional hazards models. Baseline to up to 2 years
Primary Progression-free Survival (PFS) The relationship of randomized treatment to progression free survival. The RECIST 1.1 criteria are used for disease progression. This is the criteria: progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). From start of treatment to time of progression or death, whichever occurs first. Median follow-up time was 48 months.
Secondary Tumor Response Rate Proportion of evaluable patients with complete or partial tumor response by RECIST 1.1 criteria.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. (ORR = CR + PR).		 Median followup time was 48 months.
Secondary Overall Survival (OS) The relationship of treatment to overall survival will be assessed. The number of death events in the treatment arm is reported. From start of treatment to time of death or the date of last contact, assessed up to 10 years. Median follow-up time was 48 months.
See also
  Status Clinical Trial Phase
Completed NCT00748657 - Bevacizumab in Treating Patients With Recurrent Sex Cord-Stromal Tumors of the Ovary Phase 2
Completed NCT00006227 - Paclitaxel in Treating Patients With Ovarian Stromal Cancer Phase 2