Study #GOG 0264
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
The goal of this clinical research study is to compare the study drug combination of paclitaxel and carboplatin to the combination of bleomycin, etoposide, and cisplatin in patients with a malignant stromal tumor of the ovary. The safety and side effects of the study drug combinations will also be studied.
Disease Group: Ovary
Treatment Agent: Bleomycin,Carboplatin,Cisplatin,Etoposide,Paclitaxel
Treatment Location: Both at MDACC & and Other Sites
Sponsor: Gynecologic Oncology Group,NCI
Primary Objective: 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 cordstromal tumors. Secondary Objectives: To estimate the toxicity of paclitaxel and carboplatin, and bleomycin, etoposide, and cisplatin in this patient population. To estimate overall survival for paclitaxel and carboplatin relative to that of BEP. To evaluate response rate in the subset of patients with measurable disease. Translational Research Objective: To collect fixed and/or frozen tumor tissue for future translational research studies. Exploratory Objectives 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.
IRB Review and Approval Date: 01/06/2011
Recruitment Status: Open
Projected Accrual: 128
1) Patients diagnosed with histologically confirmed ovarian stromal
tumor [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].
2) 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 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.
3) Patients must have a GOG performance Grade of 0, 1, or 2.
4) Patients of childbearing potential must have a negative serum pregnancy test and must agree to practice an effective means of birth control.
5) 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.
6) Patients who have met the pre-entry requirements. Patients must have adequate:Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to CTCAE grade 1. Platelets greater than or equal to 100,000/mcl. Renal function: Creatinine no greater than the institutional upper limit normal (ULN). Hepatic function: Bilirubin less than or equal to 1.5 x ULN (CTCAE grade 1), SGOT (AST) less than or equal to 3.0 x ULN (CTCAE grade 1) and alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE grade 1). Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE Grade 1. Hearing function: No signs of clinically significant hearing loss.
7) Patients must have signed an approved informed consent and authorization permitting release of personal health information.
8) 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.
9) 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.
10) 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.
11) Patients must be >/= 18 years of age.
1) Patients who have received any prior cytotoxic chemotherapy or
biologics for sex cord-stromal tumors (SCSTs).
2) Patients with apparent Stage I disease who have not undergone a staging procedure.
3) 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.
4) Woman who are pregnant or breastfeeding.
5) 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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