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

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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
7
sites
800 NE 10th Street
Oklahoma City, Oklahoma 73104
(855) 750-2273
Oklahoma University Cancer Institute The Peggy and Charles Stephenson Cancer Center is located on the...
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Oklahoma City, OK
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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200 Hawkins Drive
Iowa City, Iowa 52242
800-237-1225
Holden Comprehensive Cancer Center at University of Iowa Holden Comprehensive Cancer Center is dedicated to...
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Iowa City, IA
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Cleveland, Ohio 44109
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Cleveland, OH
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Columbus, OH
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Columbus, OH
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Franklin Twp, New Jersey 08043
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Franklin Twp, NJ
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