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.
- 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
Patients are followed every 3 weeks.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.
- Histologically confirmed recurrent, persistent or metastatic cervical carcinoma
(squamous or adenocarcinoma), with no potentially curative standard treatment
- Measurable disease or evaluable disease
- 18 to physiological 60
- ECOG 0-2
- Greater than 2 months
- WBC greater than 3000/mm3
- Platelet count greater than 100,000/mm3
- Bilirubin less than 1.5 times normal
- SGOT/SGPT less than 1.5 times normal
- BUN less than 1.5 times normal
- Creatinine less than 1.5 times normal
- Creatinine clearance greater than 50 mL/min
- 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:
- Not specified
- Greater than 4 weeks since prior chemotherapy
- No greater than 2 prior chemotherapy regimens
- No prior taxane or camptothecin
- No concurrent hormonal therapy except that required for nondisease related conditions
(e.g., insulin for diabetes)
- Greater than 4 weeks since prior radiation therapy
- No concurrent radiation therapy
- Greater than 4 weeks since prior surgery