Ovarian Cancer Clinical Trial
Official title:
A Phase II Study of Weekly Docetaxel and Capecitabine for Persistent or Recurrent Platinum Resistant Epithelial Carcinoma of the Ovary, Fallopian Tube or Peritoneum
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.
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.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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