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.

Condition	Treatment or Intervention	Phase
recurrent cervical cancer stage IVB cervical cancer stage IVA cervical cancer cervical squamous cell carcinoma cervical adenocarcinoma	Drug: filgrastim  Drug: paclitaxel  Drug: topotecan  Procedure: biological response modifier therapy  Procedure: chemotherapy  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

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

New York
      Herbert Irving Comprehensive Cancer Center at Columbia University, New York,  New York,  10032,  United States

Study chairs or principal investigators

Amy D. Tiersten, MD,  Study Chair,  Columbia Presbyterian Medical Center   

Study ID Numbers:  CDR0000065736; CPMC-IRB-7919; NCI-V97-1324
Record last reviewed:  December 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003065
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08