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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Investigation of Topotecan and Taxol in Patients With Recurrent/Metastatic Cancer of the Cervix

Conditions
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Cervical Cancer

Intervention / Treatment
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* Biological: filgrastim
* Drug: paclitaxel
* Drug: topotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: filgrastim|nan|
|Drug: paclitaxel|nan|
|Drug: topotecan hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent cervical cancer, stage IVB cervical cancer, stage IVA cervical cancer, cervical squamous cell carcinoma, cervical adenocarcinoma