• Toxicity [ Designated as safety issue: Yes ]
  
• Response rate [ Designated as safety issue: No ]
  
• Quality of life [ Designated as safety issue: No ]
  

• Progression-free survival [ Designated as safety issue: No ]
  
• Overall survival [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• Determine the nature and degree of toxicity of gemcitabine and topotecan in patients with recurrent or persistent platinum-refractory ovarian, fallopian tube, or primary peritoneal cavity cancer.
• Determine the response rate in patients treated with this regimen.
• Determine the quality of life of patients treated with this regimen.

Secondary

• Determine the duration of progression-free survival and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes and topotecan 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 2 additional courses beyond documentation of CR.

Quality of life is assessed at baseline, on day 1 of courses 2, 4, and 6, and then at 1 year.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 36-45 patients will be accrued for this study within 3 years.

DISEASE CHARACTERISTICS:

• Diagnosis of ovarian, fallopian tube, or primary peritoneal cavity cancer

• Recurrent or persistent platinum-refractory disease, as defined by 1 of the following:

  • Progressive disease while on a platinum compound
  • Persistent clinically measurable disease with best response as stable disease at the completion of ≥ 6 courses of therapy
  • Recurrent disease within 6 months after completion of therapy

• Measurable or evaluable disease

  • Evaluable disease, defined as CA 125 ≥ 100 U/mL (confirmed by 2 blood tests)
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI, OR ≥ 10 mm by spiral CT scan

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• GOG 0-3

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• SGOT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN
• Creatinine clearance > 50 mL/min

Other

• No clinically significant infection
• No other severe medical condition that would preclude study treatment
• No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or breast

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• Prior gemcitabine or topotecan allowed provided disease is not refractory to either drug
• At least 3 weeks since prior chemotherapy and recovered

Endocrine therapy

• Not specified

Radiotherapy

• At least 3 weeks since prior radiotherapy and recovered

Surgery

• Recovered from recent prior surgery