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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00054444
First received: February 5, 2003
Last updated: August 19, 2013
Last verified: August 2013
  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 1

Study Type: Interventional
Study Design: Primary Purpose: 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 Gynecologic Oncology Group:

Estimated Enrollment: 60
Study Start Date: September 2007
Primary Completion Date: January 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, Ohio
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210-1240
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Peter G. Rose, MD The Cleveland Clinic
  More Information

Additional Information:
Publications:
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00054444     History of Changes
Other Study ID Numbers: GOG-9913, CDR0000270680, NCI-2009-00617
Study First Received: February 5, 2003
Last Updated: August 19, 2013
Health Authority: United States: Federal Government
United States: National Cancer Institute

Keywords provided by Gynecologic Oncology Group:
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:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Cisplatin
Topotecan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014