Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients With Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors
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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 |
- Progression-free survival [ Designated as safety issue: No ]
- 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 |
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
Show 54 Study Locations| 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 23, 2013