A Phase II Study of Weekly Docetaxel and Capecitabine for Persistent or Recurrent Platinum Resistant Epithelial Carcinoma of the Ovary, Fallopian Tube or Peritoneum
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.
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Tumor Response
The number of partial and complete responders among all evaluable patients as defined using Response Evaluation Criteria in Solid Tumors guidelines
8 weeks
No
Brigitte E. Miller, MD
Study Chair
Comprehensive Cancer Center of Wake Forest University
United States: Food and Drug Administration
CCCWFU-83203
NCT00354601
January 2006
July 2008
Name | Location |
---|---|
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |