Neoplasms

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Neoplasm Metastasis

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Uterine Cervical Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

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Topotecan

Cisplatin

Topoisomerase I Inhibitors

Enzyme Inhibitors

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.

Topotecan Hydrochloride Liposomes

3-Dimensional Conformal Radiation Therapy

Peter Rose

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. 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.

PRIMARY OBJECTIVES:

I. Determine the safety and tolerability of pelvic radiotherapy, cisplatin, and topotecan in patients with locally advanced cervical cancer.

II. Determine the maximum tolerated dose (MTD) of topotecan when administered in this regimen in this patient population.

SECONDARY OBJECTIVES:

I. 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.

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

A PHASE I STUDY OF PELVIC RADIATION THERAPY WITH CONCOMITANT WEEKLY CISPLATIN AND TOPOTECAN CHEMOTHERAPY IN PATIENTS WITH CERVICAL CARCINOMA WITHOUT EXTRA-PELVIC METASTASIS

National Cancer Institute (NCI)

Gynecologic Oncology Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer	NCT00054444	Cervical Adenoc... Cervical Squamo... Stage IB Cervic... Stage IIA Cervi... Stage IIB Cervi... Stage III Cervi... Stage IVA Cervi...	Topotecan Hydro... 3-Dimensional C... Cisplatin	-	GOG Foundation
Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer	NCT00054444	Cervical Adenoc... Cervical Squamo... Stage IB Cervic... Stage IIA Cervi... Stage IIB Cervi... Stage III Cervi... Stage IVA Cervi...	Topotecan Hydro... 3-Dimensional C... Cisplatin	-	GOG Foundation
Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer	NCT00054444	Cervical Adenoc... Cervical Squamo... Stage IB Cervic... Stage IIA Cervi... Stage IIB Cervi... Stage III Cervi... Stage IVA Cervi...	Topotecan Hydro... 3-Dimensional C... Cisplatin	-	GOG Foundation

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