Conditions: Ovarian Cancer Peritoneal Cavity Cancer
Keywords: recurrent ovarian epithelial cancer peritoneal cavity cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 30
Healthy volunteers: no

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, 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.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with relapsed or refractory ovarian epithelial or peritoneal cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the response rate in patients with platinum-sensitive or -resistant relapsed or refractory ovarian epithelial or peritoneal cavity cancer treated with gemcitabine and docetaxel.

Secondary

* Determine the toxicity of this regimen in these patients.
* Determine the overall survival of patients treated with this regimen.
* Determine the time to treatment failure and progression-free survival of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to response to prior treatment with a platinum-containing regimen (platinum-resistant disease vs platinum-sensitive disease).

Patients receive gemcitabine IV over 30 minutes and docetaxel IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 3 additional courses beyond CR (≥ 6 total courses of treatment).

PROJECTED ACCRUAL: Approximately 36-62 patients (19-29 for stratum I \[platinum-resistant disease\] and 17-33 for stratum II \[platinum-sensitive disease\]) will be accrued for this study.

Arms:
arm 1: Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle

Interventions: intervention 1: Docetaxel intervention 2: Gemcitabine hydrochloride
Intervention descriptions: intervention 1: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days intervention 2: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days

Protocol document: