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

This study is currently recruiting participants.
Verified September 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01042522
First received: January 1, 2010
Last updated: October 2, 2012
Last verified: September 2012
  Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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.

PURPOSE: This randomized phase II trial is studying paclitaxel and carboplatin to see how well they work compared with bleomycin sulfate, etoposide phosphate, and cisplatin in treating patients with advanced or recurrent sex cord-ovarian stromal tumors.


Condition Intervention Phase
Ovarian Cancer
Biological: bleomycin sulfate
Drug: carboplatin
Drug: cisplatin
Drug: etoposide phosphate
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of Paclitaxel and Carboplatin vs. Bleomycin, Etoposide, and Cisplatin for Newly Diagnosed Advanced State and Recurrent Chemonaive Sex Cord-Stromal Tumors of the Ovary

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor response rate [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Utility of inhibin A and inhibin B as prognostic and predictive biomarkers for ovarian sex cord-stromal tumors [ Designated as safety issue: No ]
  • Changes in biomarkers in response to treatment [ Designated as safety issue: No ]

Estimated Enrollment: 128
Study Start Date: February 2010
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
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.
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
Experimental: Arm II
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.
Biological: bleomycin sulfate
Given IV
Drug: cisplatin
Given IV
Drug: etoposide phosphate
Given IV

Detailed Description:

OBJECTIVES:

Primary

  • To compare the progression-free survival of patients with advanced or recurrent sex cord-stromal tumors of the ovary treated with paclitaxel and carboplatin versus bleomycin sulfate, etoposide phosphate, and cisplatin.

Secondary

  • To estimate the toxicity of these regimens in this patient population.
  • To compare the overall survival of patients treated with these regimens.
  • To evaluate response rate in a subset of patients with measurable disease.
  • To collect fixed and/or frozen tumor tissue for future translational research studies.
  • 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 in response to treatment.

OUTLINE: This is a multicenter study. Patients are stratified according to presence of measurable disease (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: 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.
  • 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.

Patients undergo blood sample collection at baseline and periodically during study for laboratory biomarker analysis.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian stromal tumor, including the following cell types:

    • Granulosa cell tumor
    • Granulosa 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
  • Meets 1 of the following criteria:

    • Newly diagnosed, stage IIA-IVB disease

      • Has undergone initial surgery (for diagnosis, staging, or cytoreduction) within the past 8 weeks
      • May or may not have measurable residual disease
    • Biopsy-proven recurrent disease of any stage

      • Chemotherapy-naive disease
  • Patients with measurable disease must have ≥ 1 "target lesion" to be used to assess response

    • 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 ≥ 90 days following completion of radiotherapy

PATIENT CHARACTERISTICS:

  • GOG performance status 0-2
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine normal
  • Bilirubin ≤ 1.5 times ULN
  • SGOT ≤ 3.0 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Pulmonary function sufficient to receive bleomycin sulfate, as indicated by the following:

    • Normal lung expansion
    • Absence of crackles on auscultation
    • Normal DLCO, defined as > 80% predicted
  • History of hypersensitivity reactions to chemotherapy administered for a prior cancer diagnosis allowed, unless the hypersensitivity reaction consisted of anaphylaxis not amenable to desensitization
  • No peripheral neuropathy > grade 1
  • No signs of clinically significant hearing loss
  • No other invasive malignancies within the past 5 years except for curatively treated nonmelanoma skin cancer
  • No other medical history or condition that, in the opinion of the investigator, would preclude study participation

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from recent surgery, radiotherapy, or chemotherapy
  • No prior cytotoxic chemotherapy or biologic therapy for sex cord-stromal tumors
  • At least 1 week since prior hormonal therapy directed at the malignant tumor
  • No other concurrent antineoplastic therapy, including cytotoxic therapy, biologic therapy, hormonal therapy, or radiotherapy

    • Concurrent hormone replacement therapy allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01042522

  Hide Study Locations
Locations
United States, California
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center Recruiting
Burbank, California, United States, 91505
Contact: Clinical Trials Office - Providence Saint Joseph Medical Cente     818-847-3220        
Olive View - UCLA Medical Center Foundation Recruiting
Sylmar, California, United States, 91342
Contact: Christine Holschneider, MD     310-206-5161        
United States, Georgia
Central Georgia Gynecologic Oncology Recruiting
Macon, Georgia, United States, 31201
Contact: Gary L. Eddy, MD     476-633-6090        
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31403-3089
Contact: Clinical Trials Office - Curtis and Elizabeth Anderson Cancer     912-350-8568        
United States, Illinois
University of Chicago Cancer Research Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research     773-834-7424        
Gynecologic Oncology Recruiting
Hinsdale, Illinois, United States, 60521
Contact: Sudarshan K. Sharma, MD     630-856-6757        
Regional Cancer Center at Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781-0001
Contact: Clinical Trials Office - Regional Cancer Center at Memorial Me     217-788-4233        
United States, Indiana
St. Vincent Oncology Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Gregory P. Sutton, MD     317-415-6740        
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa Recruiting
Iowa City, Iowa, United States, 52242-1002
Contact: Cancer Information Service     800-237-1225        
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536-0093
Contact: Clinical Trials Office - Markey Cancer Center at University of     859-257-3379        
United States, Maryland
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital Recruiting
Baltimore, Maryland, United States, 21215
Contact: Mark A. Miller     410-601-4734        
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231-2410
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce     410-955-8804     jhcccro@jhmi.edu    
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Thomas E. Buekers     313-916-1850        
Green Bay Oncology, Limited - Escanaba Recruiting
Escanaba, Michigan, United States, 49431
Contact: Jonathan E. Tammela     800-432-6049        
Dickinson County Healthcare System Recruiting
Iron Mountain, Michigan, United States, 49801
Contact: Jonathan E. Tammela     906-774-1313        
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Raymond S. Lord, MD     269-373-7458        
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49001
Contact: Raymond S. Lord, MD     269-373-7458        
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007-3731
Contact: Clinical Trials Office - West Michigan Cancer Center     269-373-7458        
United States, Mississippi
University of Mississippi Cancer Clinic Recruiting
Jackson, Mississippi, United States, 39216
Contact: James T. Thigpen, MD     601-984-5590        
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: David G. Mutch, MD     314-362-3181        
Hulston Cancer Center at Cox Medical Center South Recruiting
Springfield, Missouri, United States, 65807
Contact: Robert L. Carolla     417-269-5257        
CCOP - Cancer Research for the Ozarks Recruiting
Springfield, Missouri, United States, 65802
Contact: Robert L. Carolla     417-269-4520        
United States, Nebraska
Methodist Estabrook Cancer Center Recruiting
Omaha, Nebraska, United States, 68114
Contact: Peter C. Morris, MD     402-354-5250        
United States, Nevada
Women's Cancer Center - La Canada Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Nick M. Spirtos, MD     408-866-3843        
United States, New Mexico
Southwest Gynecologic Oncology Associates, Incorporated Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Carolyn Y. Muller, MD     505-272-0185        
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131-5636
Contact: Clinical Trials Office - University of New Mexico Cancer Cente     505-272-6972        
United States, New York
Stony Brook University Cancer Center Recruiting
Stony Brook, New York, United States, 11794-9446
Contact: Clinical Trials Office - Stony Brook University Cancer Center     800-862-2215        
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7295
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente     877-668-0683; 919-966-4432        
Blumenthal Cancer Center at Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28232-2861
Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas     704-355-2884        
Duke Cancer Institute Recruiting
Durham, North Carolina, United States, 27710
Contact: Clinical Trials Office - Duke Cancer Institute     888-275-3853        
United States, Ohio
Cleveland Clinic Cancer Center at Fairview Hospital Recruiting
Cleveland, Ohio, United States, 44111
Contact: Clinical Trials Office - Cleveland Clinic Cancer Center at Fai     216-476-9362        
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente     866-223-8100        
MetroHealth Cancer Care Center at MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Peter G. Rose, MD     216-444-1712        
Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center     800-641-2422        
Riverside Methodist Hospital Cancer Care Recruiting
Columbus, Ohio, United States, 43214-3998
Contact: Clinical Trials Office - Riverside Methodist Hospital Cancer C     614-566-4475        
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service     866-627-7616     Jamesline@osumc.edu    
Hillcrest Cancer Center at Hillcrest Hospital Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: Peter G. Rose, MD     216-444-1712        
Lake/University Ireland Cancer Center Recruiting
Mentor, Ohio, United States, 44060
Contact: Steven E. Waggoner, MD     216-844-5011        
United States, Oklahoma
Oklahoma University Cancer Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Robert S. Mannel, MD     405-271-8787        
Cancer Care Associates - Saint Francis Campus Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Robert S. Mannel, MD     405-271-8787        
United States, Pennsylvania
Rosenfeld Cancer Center at Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Clinical Trials Office - Rosenfeld Cancer Center at Abington M     215-481-2402        
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Recruiting
Allentown, Pennsylvania, United States, 18105
Contact: Richard M. Boulay, MD     610-402-3650        
United States, South Dakota
Sanford Cancer Center at Sanford USD Medical Center Recruiting
Sioux Falls, South Dakota, United States, 57117-5039
Contact: Clinical Trials Office - Sanford Cancer Center     605-328-1367        
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a     866-460-4673; 214-648-7097        
Parkland Memorial Hospital Recruiting
Dallas, Texas, United States, 75235
Contact: David S. Miller, MD     214-648-3026        
M. D. Anderson Cancer Center at University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U     713-792-3245        
United States, Wisconsin
Green Bay Oncology, Limited at St. Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Jonathan E. Tammela     920-884-3135        
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54301-3526
Contact: Jonathan E. Tammela     920-432-6049        
St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54307-3508
Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer     920-433-8889        
St. Mary's Hospital Medical Center - Green Bay Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Jonathan E. Tammela     920-498-4200        
Holy Family Memorial Medical Center Cancer Care Center Recruiting
Manitowoc, Wisconsin, United States, 54221-1450
Contact: Clinical Trials Office - Holy Family Memorial Medical Center C     920-320-2749        
Bay Area Cancer Care Center at Bay Area Medical Center Recruiting
Marinette, Wisconsin, United States, 54143
Contact: Jonathan E. Tammela     715-735-6523        
Green Bay Oncology, Limited - Oconto Falls Recruiting
Oconto Falls, Wisconsin, United States, 54154
Contact: Jonathan E. Tammela     920-846-3444        
Green Bay Oncology, Limited - Sturgeon Bay Recruiting
Sturgeon Bay, Wisconsin, United States, 54235
Contact: Jonathan E. Tammela     800-432-6049        
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Jubilee Brown, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01042522     History of Changes
Other Study ID Numbers: CDR0000662814, GOG-0264
Study First Received: January 1, 2010
Last Updated: October 2, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
ovarian stromal cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Sex Cord-Gonadal Stromal Tumors
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Gonadal Tissue
Neoplasms by Histologic Type
Bleomycin
Etoposide phosphate
Cisplatin
Etoposide
Carboplatin
Paclitaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on May 19, 2013