GOG 264: 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
This is a multicenter study. Patients will be randomized in a 1:1 ratio to paclitaxel and carboplatin or bleomycin, etoposide, and cisplatin (BEP). A BEP control arm is being used because historical data for progression free survival and other endpoints are limited and not consistent across studies in this patient population. The randomization will be stratified by the presence or absence of measurable disease.
Arm I: Paclitaxel and Carboplatin ? Patients will receive the drug paclitaxel intravenously over three hours followed by the drug carboplatin over one hour (for a total infusion time of four hours) every 21 days. They will continue to receive this treatment for a total of six cycles as long as their cancer does not get worse and they do not experience unacceptable side effects.
Arm II: Bleomycin, Etoposide, and Cisplatin (BEP) - Patients will receive the drug bleomycin intravenously every 21 days. They will also receive the drug etoposide intravenously over 60 minutes followed by the drug cisplatin over 30 minutes (for a total infusion time of about an hour) on the first 5 days of every cycle. They will continue this treatment for a total of four cycles as long as their cancer does not get worse and they do not experience unacceptable side effects.
About 10 people will take part in this study at UT Southwestern and Parkland Health & Hospital System. There will be about 128 participants will be enrolled on this study in multiple medical centers throughout the United States.
3.11 Patients diagnosed with histologically confirmed ovarian stromal tumor [granulosa cell tumor, granulosa cellxtheca cell tumor, Sertoli-Leydig cell tumor (androblastoma), steroid (lipid) cell tumor, gynandroblastoma, unclassified sex cord-stromal tumor, sex cord tumor with annular tubules].
3.12 Patients must have newly diagnosed, Stage IIA x 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.
3.13 Patients must have a GOG performance Grade of 0, 1, or 2.
3.14 Patients of childbearing potential must have a negative serum pregnancy test and must agree to practice an effective means of birth control.
3.15 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 (Section 8.0). Tumors within a previously irradiated field will be designated as
* lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
3.16 Patients who have met the pre-entry requirements specified in Section 7.0. Patients must
- 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 limits of normal.
- 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.
3.17 Patients must have signed an approved informed consent and authorization permitting release of personal health information.
3.18 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.
3.19 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.
3.110 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.
3.111 Patients must be ≥ 18 years of age.