Docetaxel and Capecitabine 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
About this trial
This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring 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
Eligibility Criteria
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
Sites / Locations
- Wake Forest University Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Weekly Docetaxel and Capecitabine
Weekly Docetaxel and Capecitabine