A Phase II Study of Weekly Docetaxel and Capecitabine for Persistent or Recurrent Platinum Resistant Epithelial Carcinoma of the Ovary, Fallopian Tube or Peritoneum
A Phase II Study of Weekly Docetaxel and Capecitabine for Persistent or Recurrent Platinum Resistant Epithelial Carcinoma of the Ovary, Fallopian Tube or Peritoneum
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.
OBJECTIVES:
Primary
Secondary
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.
Inclusion Criteria:
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
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:
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:
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:
PRIOR CONCURRENT THERAPY: