Gemcitabine and Docetaxel in Treating Patients With Relapsed or Refractory Ovarian Epithelial or Peritoneal Cancer

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.

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