Combination Chemotherapy Consisting of Gemcitabine And Topotecan in Treating Patients With Refractory or Recurrent Ovarian or Fallopian Tube Cancer

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of gemcitabine and topotecan in treating patients with refractory or recurrent ovarian or fallopian tube cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gemcitabine; Topotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically documented refractory or recurrent ovarian epithelial or fallopian tube cancer

• No borderline ovarian cancer

• Extra-ovarian papillary serous tumors eligible

• Must not be eligible for any higher priority phase II or III GOG protocol

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• GOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• SGOT no greater than 3 times upper limit of normal (ULN)

• Bilirubin no greater than 1.5 mg/dL

• Elevated levels of alkaline phosphatase allowed

Renal:

• Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• No angina pectoris or clinically significant multifocal uncontrolled cardiac dysrhythmias

• No uncontrolled hypertension

Other:

• No other active malignancy

• No prior malignancy within the past 5 years except nonmelanomatous skin cancer

• No active infection

• No underlying medical problem that would prevent compliance

• No known hypersensitivity to E. coli-derived drug preparations

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Must have received at least 1 prior platinum- and paclitaxel-based regimen

• At least 4 weeks since prior chemotherapy

• No prior topotecan and/or gemcitabine

• No prior chemotherapy for a different prior malignancy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy to more than 10% of bone marrow

• At least 2 weeks since limited field radiation therapy

Surgery:

• Not specified