A Phase I Study Of Pelvic Radiation Therapy With Concomitant Cisplatin And Weekly Topotecan (IND# 58,13) Chemotherapy In Patients With Cervical Carcinoma And Paraortic Nodal Metastasis As The Only Evidence Of Extrapelvic Disease
OBJECTIVES:
Primary
- Determine the safety and tolerability of pelvic radiotherapy, cisplatin, and topotecan
in patients with locally advanced cervical cancer.
- Determine the maximum tolerated dose (MTD) of topotecan when administered in this
regimen in this patient population.
Secondary
- Determine the site of recurrence (local vs distant) in patients treated with this
regimen.
OUTLINE: This is a multicenter, dose-escalation study of topotecan.
Patients undergo radiotherapy 5 days a week for 6 weeks. Patients receive cisplatin IV and
topotecan IV over 30 minutes once weekly for a total of 6 weeks in the absence of disease
progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which 1 of 6 patients
experiences dose-limiting toxicity. Once the MTD is determined, an additional cohort of 20
patients receives treatment as above at the MTD.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Peter G. Rose, MD
Study Chair
The Cleveland Clinic
United States: Federal Government
CDR0000270680
NCT00054444
September 2007
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44109 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus, Ohio 43210-1240 |