Gemcitabine and Docetaxel in Treating Patients With Relapsed or Refractory Ovarian Epithelial or Peritoneal Cancer

Phase 2

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Docetaxel & Gemcitabine hydrochloride	Gemcitabine hydrochloride	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
Docetaxel & Gemcitabine hydrochloride	Docetaxel	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

Primary Outcome Measures

Name	Time	Method
Response Rate to the Combination of Gemcitabine and Docetaxel in Patients With Platinum Sensitive and Resistant Epithelial Ovarian or Peritoneal Cancer.	Disease status by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or Gynecological Cancer Intergroup (GCIG) CA-125 criteria was assessed every two cycles from enrollment up to progression, death, or five years (whichever occurred first).

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival	Every two cycles until disease progression or death, assessed up to 5 years	Progression-free survival estimated using Kaplan-Meier's product-limit method.

Locations (4): Barbara Ann Karmanos Cancer Institute
🇺🇸
Detroit, Michigan, United States
Northern Virginia Pelvic Surgery Assoc
🇺🇸
Annandale, Virginia, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
🇺🇸
Columbus, Ohio, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸
Dearborn, Michigan, United States