Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

Primary

1. Determine the safety and tolerability of pelvic radiotherapy, cisplatin, and topotecan in patients with locally advanced cervical cancer.
2. Determine the maximum tolerated dose (MTD) of topotecan when administered in this regimen in this patient population.

Secondary

1. Determine the site of recurrence (local vs distant) in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed primary invasive carcinoma of the uterine cervix
  • Stages IB2, II, IIIB, and IVA disease
  • Any cell type

• No known metastasis to scalene nodes or organs outside the radiation field

• No known intraperitoneal metastases

• No evidence of extrapelvic disease based on negative CT or PET scan

• Must enroll within 8 weeks of diagnosis

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for any prior malignancy
• No prior cytotoxic chemotherapy for this malignancy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy for any prior malignancy
• No prior pelvic or abdominal radiotherapy for this malignancy

Surgery

• See Patient Characteristics- Renal

Other

• No prior therapy for this malignancy

Patient Characteristics:

Age

• Not specified

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• SGOT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN

Renal

• Creatinine normal

  OR

• Creatinine clearance > 50 mL/min
• Prior ureteral obstruction allowed provided stent or nephrostomy tube has been placed
• No renal abnormalities, such as pelvic kidney, horseshoe kidney, or prior renal transplantation that would require modification of radiation fields

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other malignancy within the past 5 years except nonmelanoma skin cancer
• No septicemia or severe infection
• No other medical or psychiatric condition that would preclude study compliance

Expected Enrollment

A total of 30 patients will be accrued for this study.

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.

Rose PG, Sill MW, McMeekin DS, et al.: A phase I study of concurrent weekly topotecan and cisplatin chemotherapy with whole pelvic radiation therapy in locally advanced cervical cancer: A gynecologic oncology group study. Gynecol Oncol : , 2011.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Peter Rose, MD, Protocol chair		Ph: 216-444-1712; 800-862-7798 Email: rosep@ccf.org

Registry Information
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
Trial Start Date		2007-09-10
Trial Completion Date		2011-03-31
Registered in ClinicalTrials.gov		NCT00054444
Date Submitted to PDQ		2002-12-23
Information Last Verified		2010-11-23
NCI Grant/Contract Number		CA27469

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