Ovarian Cancer Clinical Trial
Gemcitabine and Docetaxel in Treating Patients With Relapsed or Refractory Ovarian Epithelial or Peritoneal Cancer
Summary
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
Determine the response rate in patients with platinum-sensitive or -resistant relapsed or refractory ovarian epithelial or peritoneal cavity cancer treated with gemcitabine and docetaxel.
Secondary
Determine the toxicity of this regimen in these patients.
Determine the overall survival of patients treated with this regimen.
Determine the time to treatment failure and progression-free survival of patients treated with this regimen.
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.
Eligibility 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
Platinum resistance is defined as relapsed or progressive disease within 6 months after completion of a platinum-containing regimen
Measurable or evaluable disease
Evaluable disease is defined as CA 125 > 70 U/mL that has doubled from a baseline determination confirmed by ≥ 2 separate blood samples taken > 4 weeks apart OR other evidence demonstrating progressive disease after initial treatment regimen
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
ECOG 0-2
Life expectancy
Not specified
Hematopoietic
WBC ≥ 3,000/mm^3
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 8.0 g/dL
Hepatic
Bilirubin normal
Meets 1 of the following criteria:
AST or ALT normal AND alkaline phosphatase (AP) ≤ 5 times upper limit of normal (ULN)
AST or ALT ≤ 1.5 times ULN AND AP ≤ 2.5 times ULN
AST or ALT ≤ 5 times ULN AND AP normal
Renal
Creatinine clearance > 30 mL/min
Creatinine < 2.5 mg/dL
Cardiovascular
No congestive heart failure
No second or third degree heart block
No myocardial infarction within the past 3 months
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No peripheral neuropathy > grade 1
No other malignancy within the past 2 years except adequately treated skin cancer or carcinoma in situ of the cervix
No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
See Disease Characteristics
Prior paclitaxel allowed
No more than 1 prior chemotherapy regimen
First-line platinum-based chemotherapy followed by consolidation therapy in the setting of a clinical and serologic complete response is considered 1 regimen
No prior gemcitabine or docetaxel
Endocrine therapy
Not specified
Radiotherapy
At least 4 weeks since prior radiotherapy and recovered
Surgery
Not specified
Other
More than 28 days since prior and no other concurrent investigational drugs for this cancer
No other concurrent treatment or alternative therapy for this cancer
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There are 4 Locations for this study
Dearborn Michigan, 48123, United States
Detroit Michigan, 48201, United States
Columbus Ohio, 43210, United States
Annandale Virginia, 22003, United States
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