Docetaxel and Capecitabine in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cavity Cancer
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|ClinicalTrials.gov Identifier: NCT00354601|
Recruitment Status : Terminated (funding withdrawn)
First Posted : July 20, 2006
Results First Posted : May 18, 2009
Last Update Posted : August 30, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer||Drug: capecitabine Drug: docetaxel||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||July 2008|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|