Phase II Investigation of Topotecan and Taxol in Patients With Recurrent/Metastatic Cancer of the Cervix
filgrastim
+ paclitaxel
+ topotecan hydrochloride
Urogenital Diseases+10
+ Genital Diseases
+ Uterine Cervical Diseases
Treatment Study
Summary
Study start date: January 1, 1997
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, United StatesOpen Herbert Irving Comprehensive Cancer Center at Columbia University in Google Maps