Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as topotecan and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best way to give radiation therapy when given together with topotecan and cisplatin in treating patients with locally advanced cervical cancer. This trial is also studying the best dose of topotecan when given in this regimen.
Drug: topotecan hydrochloride
Radiation: radiation therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||September 2007|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
- 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.
- 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.
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Iowa|
|Holden Comprehensive Cancer Center at University of Iowa|
|Iowa City, Iowa, United States, 52242-1002|
|United States, New Jersey|
|Cancer Institute of New Jersey at Cooper - Voorhees|
|Voorhees, New Jersey, United States, 08043|
|United States, Ohio|
|MetroHealth Cancer Care Center at MetroHealth Medical Center|
|Cleveland, Ohio, United States, 44109|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210-1240|
|Riverside Methodist Hospital Cancer Care|
|Columbus, Ohio, United States, 43214-3998|
|United States, Oklahoma|
|Oklahoma University Cancer Institute|
|Oklahoma City, Oklahoma, United States, 73104|
|Study Chair:||Peter G. Rose, MD||The Cleveland Clinic|