Docetaxel and Capecitabine in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cavity Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Study of Weekly Docetaxel and Capecitabine for Persistent or Recurrent Platinum Resistant Epithelial Carcinoma of the Ovary, Fallopian Tube or Peritoneum

Conditions
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Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Intervention / Treatment
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* Drug: capecitabine
* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DISEASE CHARACTERISTICS: Diagnosis of 1 of the following: Ovarian epithelial adenocarcinoma Fallopian tube cancer Peritoneal cavity cancer Recurrent or persistent disease after no more than 2 prior treatment regimens (1 regimen for primary disease and/or 1 regimen for recurrent disease) Platinum-resistant disease, defined as 1 of the following: Treatment-free interval < 6 months after platinum-based therapy Disease progression during platinum-based therapy Measurable disease by physical exam, chest x-ray, CT scan, or MRI No brain metastases PATIENT CHARACTERISTICS: Gynecologic Oncology Group performance status 0-2 Life expectancy > 6 months Absolute neutrophil count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 8 g/dL Creatinine clearance ≥ 50 mL/min Bilirubin normal AST or ALT and alkaline phosphatase (AP) meeting 1 of the following criteria: AST or ALT ≤ 5 times upper limit of normal (ULN) AND AP normal AST or ALT ≤ 1.5 times ULN AND AP ≤ 2.5 times ULN AST or ALT normal AND AP ≤ 5 times ULN No peripheral neuropathy > grade 2 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after completion of study treatment No other concurrent malignancy except for curatively treated nonmelanoma skin cancer No prior invasive malignancy < 5 years after curative therapy No serious uncontrolled medical or psychiatric illness that would preclude study participation or limit survival to < 6 months No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 or to fluoropyrimidine therapy or fluorouracil No inability to tolerate oral medication due to bowel obstruction, lack of physical integrity of the upper gastrointestinal tract, inability to swallow, or malabsorption syndrome No serious concurrent infections No clinically significant cardiac disease not well controlled with medication, including any of the following: Congestive heart failure Symptomatic coronary artery disease Symptomatic cardiac arrhythmias Myocardial infarction within the past 12 months PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior docetaxel or capecitabine or other fluoropyrimidine therapy Recovered from prior therapy At least 2 weeks since prior major surgery At least 4 weeks since prior chemotherapy, hormone therapy, or radiotherapy No other concurrent chemotherapeutic agents, biological therapy, radiotherapy, or other investigational agents

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weekly Docetaxel and Capecitabine<br>Weekly Docetaxel and Capecitabine | Drug: capecitabine<br>* oral capecitabine twice daily on days 1-21<br>Drug: docetaxel<br>* docetaxel IV over 30 minutes on days 1, 8, and 15<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Progression | Progression is defined as a 20% increase in tumor size of all the target lesions along the longest diameter | 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. | 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. | Pre-entry, day 1, treatment end | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fallopian tube cancer, peritoneal cavity cancer, recurrent ovarian epithelial cancer, ovarian clear cell cystadenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian mucinous cystadenocarcinoma, ovarian serous cystadenocarcinoma, ovarian undifferentiated adenocarcinoma