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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
oral capecitabine twice daily on days 1-21
docetaxel IV over 30 minutes on days 1, 8, and 15
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Objective Tumor Response
The number of partial and complete responders among all evaluable patients as defined using Response Evaluation Criteria in Solid Tumors guidelines
Time frame: 8 weeks
Time to Progression
Progression is defined as a 20% increase in tumor size of all the target lesions along the longest diameter
Time frame: Evaluated every 8 weeks during treatment
Number of Participants With Grade 3 or Higher Toxicity
summary of grade 3 (per Common Toxicity Criteria) or higher toxicities which generally is described as a severe adverse reaction or symptom.
Time frame: Days 1, 8, 15, 21 of each course and treatment end (28 days after last dose or start of new therapy)
Quality of Life
comparison of treatment end to pre entry and day 1 of each treatment cycle.
Time frame: Pre-entry, day 1, treatment end
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