Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer

Status:	Archived
Conditions:	Cervical Cancer, Cancer, Women's Studies
Therapuetic Areas:	Oncology, Reproductive
Healthy:	No
Age Range:	Any
Updated:	7/1/2011

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

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.

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.

We found this trial at

sites

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Columbus, Ohio 43210

from

Columbus, OH