NCT00354601

Docetaxel and Capecitabine in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cavity Cancer

A Phase II Study of Weekly Docetaxel and Capecitabine for Persistent or Recurrent Platinum Resistant Epithelial Carcinoma of the Ovary, Fallopian Tube or Peritoneum

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving docetaxel together with carboplatin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel together with capecitabine works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer.

Detailed description

OBJECTIVES: Primary * Determine the response rate in patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer treated with docetaxel and capecitabine. Secondary * Determine the time to progression in patients treated with this regimen. * Determine the toxicity of this regimen in these patients. * Determine the quality of life during treatment of these patients. OUTLINE: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for ≥ 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, on day 1 of each course, and then at completion of study treatment. After completion of study treatment, patients are followed every 2-3 months.

Conditions

• Fallopian Tube Cancer
• Ovarian Cancer
• Peritoneal Cavity Cancer

Interventions

Type	Name	Description
DRUG	capecitabine	oral capecitabine twice daily on days 1-21
DRUG	docetaxel	docetaxel IV over 30 minutes on days 1, 8, and 15

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-05-01
• Completion: 2008-07-01
• First posted: 2006-07-20
• Last updated: 2017-08-30
• Results posted: 2009-05-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study