Expired Study
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New York, New York 10032


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00003065


Primary Contact:

Study Chair
Amy D. Tiersten, MD
Herbert Irving Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10032
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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