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About
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with relapsed or refractory ovarian epithelial or peritoneal cancer.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to response to prior treatment with a platinum-containing regimen (platinum-resistant disease vs platinum-sensitive disease).
Patients receive gemcitabine IV over 30 minutes and docetaxel IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 3 additional courses beyond CR (≥ 6 total courses of treatment).
PROJECTED ACCRUAL: Approximately 36-62 patients (19-29 for stratum I [platinum-resistant disease] and 17-33 for stratum II [platinum-sensitive disease]) will be accrued for this study.
Enrollment
Sex
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial or peritoneal cavity cancer
Relapsed or refractory disease after prior first-line therapy with a platinum-containing regimen
Platinum-sensitive or -resistant disease
Measurable or evaluable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Bilirubin normal
Meets 1 of the following criteria:
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
See Disease Characteristics
Prior paclitaxel allowed
No more than 1 prior chemotherapy regimen
No prior gemcitabine or docetaxel
Endocrine therapy
Radiotherapy
Surgery
Other
Primary purpose
Allocation
Interventional model
Masking
30 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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