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

Herbert Irving Comprehensive Cancer Center

Status and phase: Completed; Phase 2

Conditions: Cervical Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00003065

NCI-V97-1324

CDR0000065736

CPMC-IRB-7919

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

Full description

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.

Enrollment: 25 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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