Status:
TERMINATED
Docetaxel and Capecitabine in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cavity Cancer
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Fallopian Tube Cancer
Ovarian Cancer
Eligibility:
FEMALE
18-120 years
Phase:
PHASE2
Brief Summary
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. Givi...
Detailed Description
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 ca...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00354601
Start Date
January 1 2006
End Date
July 1 2008
Last Update
August 30 2017
Active Locations (1)
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1
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096