NCT00227721

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

Phase II Trial of Weekly Gemcitabine and Docetaxel Combination Therapy for Relapsed Ovarian or Peritoneal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Robert Morris · Academic / Other
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer
• Peritoneal Cavity Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days
DRUG	Gemcitabine hydrochloride	800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days

Timeline

• Start date: 2004-02-01
• Primary completion: 2011-06-01
• Completion: 2017-02-01
• First posted: 2005-09-28
• Last updated: 2020-12-02
• Results posted: 2015-02-09

Locations

4 sites across 1 country: United States