Docetaxel and Capecitabine in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cavity Cancer
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.
|Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer||Drug: capecitabine Drug: docetaxel||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|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|
- Objective Tumor Response [ Time Frame: 8 weeks ]The number of partial and complete responders among all evaluable patients as defined using Response Evaluation Criteria in Solid Tumors guidelines
- Time to Progression [ Time Frame: Evaluated every 8 weeks during treatment ]Progression is defined as a 20% increase in tumor size of all the target lesions along the longest diameter
- Number of Participants With Grade 3 or Higher Toxicity [ Time Frame: Days 1, 8, 15, 21 of each course and treatment end (28 days after last dose or start of new therapy) ]summary of grade 3 (per Common Toxicity Criteria) or higher toxicities which generally is described as a severe adverse reaction or symptom.
- Quality of Life [ Time Frame: Pre-entry, day 1, treatment end ]comparison of treatment end to pre entry and day 1 of each treatment cycle.
|Study Start Date:||January 2006|
|Study Completion Date:||July 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Experimental: Weekly Docetaxel and Capecitabine
Weekly Docetaxel and Capecitabine
oral capecitabine twice daily on days 1-21Drug: docetaxel
docetaxel IV over 30 minutes on days 1, 8, and 15
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00354601
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Study Chair:||Brigitte E. Miller, MD||Wake Forest University Health Sciences|