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

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Herbert Irving Comprehensive Cancer Center
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel; Topotecan

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