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

Gynecologic Oncology Group (GOG)

Status and phase: Terminated; Phase 1

Conditions: Primary Peritoneal Cavity Cancer; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Drug: topotecan hydrochloride; Biological: filgrastim; Drug: gemcitabine hydrochloride

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00003382

GOG-9702

CDR0000066377

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

• Determine the maximum tolerated doses of the combination of gemcitabine and topotecan administered with and without filgrastim (G-CSF) in patients with refractory ovarian or fallopian tube cancer.
• Describe and quantitate the clinical toxicities of these regimens in this patient population.

OUTLINE: This is a dose escalation study.

Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and topotecan IV over 30 minutes on days 2-4. Some patients receive filgrastim (G-CSF) subcutaneously on days 9-14. Treatment repeats every 28 days for up to 5-10 courses.

Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose below that at which 2 of 6 patients experience dose limiting toxicity (DLT). Dose escalation of gemcitabine then continues in cohorts of 3-6 patients until the MTD is determined. The MTD is defined as the dose below that at which 2 of 6 patients experience DLT.

Patients are followed every 2-3 months for 2 years, every 6 months for 3 years, then annually thereafter.

PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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