Topotecan and Paclitaxel in Treating Patients With Recurrent or Metastatic Cancer of the Cervix

Herbert Irving Comprehensive Cancer Center25 enrolled

Overview

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 II trial to study the effectiveness of topotecan and paclitaxel in treating patients who have recurrent or metastatic cancer of the cervix.

OBJECTIVES: * Determine the response, time to progression, disease free survival, and overall survival of patients with recurrent and/or metastatic cancer of the cervix treated with a combination of topotecan and paclitaxel. * Determine the feasibility and toxicity of this regimen in these patients. OUTLINE: Patients receive paclitaxel IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5. Filgrastim (G-CSF) is administered on days 6-14. Treatment repeats every 21 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 weeks. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Cervical Cancer

Interventions

filgrastimBIOLOGICAL

paclitaxelDRUG

topotecan hydrochlorideDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed recurrent, persistent or metastatic cervical carcinoma (squamous or adenocarcinoma), with no potentially curative standard treatment * Measurable disease or evaluable disease PATIENT CHARACTERISTICS: Age: * 18 to physiological 60 Performance status: * ECOG 0-2 Life expectancy: * Greater than 2 months Hematopoietic: * WBC greater than 3000/mm3 * Platelet count greater than 100,000/mm3 Hepatic: * Bilirubin less than 1.5 times normal * SGOT/SGPT less than 1.5 times normal Renal: * BUN less than 1.5 times normal * Creatinine less than 1.5 times normal * Creatinine clearance greater than 50 mL/min Other: * Ineligible for other high priority national or institutional study * Not pregnant or nursing * HIV negative * No prior malignancy except nonmelanoma skin cancer * No serious medical or psychiatric illness preventing treatment or informed consent PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Greater than 4 weeks since prior chemotherapy * No greater than 2 prior chemotherapy regimens * No prior taxane or camptothecin Endocrine therapy: * No concurrent hormonal therapy except that required for nondisease related conditions (e.g., insulin for diabetes) Radiotherapy: * Greater than 4 weeks since prior radiation therapy * No concurrent radiation therapy Surgery: * Greater than 4 weeks since prior surgery

Locations (1)

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, United States

Data from ClinicalTrials.gov

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