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Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2009
First Received: February 5, 2003   Last Updated: November 20, 2009   History of Changes
Sponsor: Gynecologic Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00054444
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
Drug: cisplatin
Drug: topotecan hydrochloride
Radiation: radiation therapy
Phase I

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 60
Study Start Date: September 2007
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

PATIENT CHARACTERISTICS:

Age

  • Not specified

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054444

Locations
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami Recruiting
Miami, Florida, United States, 33136
Contact: University of Miami Sylvester Comprehensive Cancer Center Clin     866-574-5124     Sylvester@emergingmed.com    
United States, Illinois
University of Chicago Cancer Research Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research     773-834-7424        
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa Recruiting
Iowa City, Iowa, United States, 52242-1002
Contact: Cancer Information Service     800-237-1225        
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo     856-325-6757        
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service     866-627-7616     osu@emergingmed.com    
MetroHealth Cancer Care Center at MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Peter G. Rose, MD     216-444-1712        
Riverside Methodist Hospital Cancer Care Recruiting
Columbus, Ohio, United States, 43214-3998
Contact: Clinical Trials Office - Riverside Methodist Hospital Cancer C     614-566-4475        
United States, Oklahoma
Cancer Care Associates - Saint Francis Campus Recruiting
Tulsa, Oklahoma, United States, 74136-1929
Contact: Robert S. Mannel, MD     405-271-8787        
Oklahoma University Cancer Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Robert S. Mannel, MD     405-271-8787        
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Peter G. Rose, MD The Cleveland Clinic
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000270680, GOG-9913
Study First Received: February 5, 2003
Last Updated: November 20, 2009
ClinicalTrials.gov Identifier: NCT00054444     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
cervical adenocarcinoma
cervical squamous cell carcinoma
stage IB cervical cancer
stage IIA cervical cancer
stage IIB cervical cancer
stage III cervical cancer
stage IVA cervical cancer

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Enzyme Inhibitors
Topotecan
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2009