Clinical Trial: Comparison of Three Chemotherapy Regimens in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer

This study is no longer recruiting patients.

Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for cervical cancer.

PURPOSE: Randomizedphase III trial to compare the effectiveness of three different chemotherapy regimens in treating patients with stage IVB, recurrent, or persistent cervical cancer.

Condition Treatment or Intervention Phase
recurrent cervical cancer
stage IVB cervical cancer
cervical squamous cell carcinoma
cervical adenocarcinoma
cervical adenosquamous cell carcinoma
 Drug: cisplatin
 Drug: topotecan
 Procedure: chemotherapy
Phase III

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Cervical Cancer;   Soft Tissue Sarcoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Cisplatin Only Versus Cisplatin Plus Topotecan Versus Methotrexate, Vinblastine, Doxorubicin, and Cisplatin in Patients With Stage IVB, Recurrent, or Persistent Carcinoma of the Cervix

Further Study Details: 

OBJECTIVES:

  • Compare the response rate and survival of patients with stage IVB, recurrent, or persistent carcinoma of the cervix treated with cisplatin only vs cisplatin plus topotecan vs methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC). (Arm III (MVAC) closed to accrual effective 07/23/2001.)
  • Compare the toxic effects of these regimens in this patient population.
  • Compare health-related quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to GOG performance status. Patients are randomized to one of three treatment arms. (Arm III closed to accrual effective 07/23/2001.)

  • Arm I: Patients receive cisplatin IV once every 21 days.
  • Arm II:Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin IV (beginning after topotecan infusion) on day 1. Courses repeat every 21 days.
  • Arm III:Patients receive methotrexate IV on days 1, 15, and 22, vinblastine IV on days 2, 15, and 22, and doxorubicin IV and cisplatin IV on day 2. Courses repeat every 28 days. (Arm III closed to accrual effective 07/23/2001.) Treatment in all arms continues for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. (Arm III closed to accrual effective 07/23/2001.)

Quality of life is assessed before randomization, before course 2, before course 5 (arms I and II), before course 4 (arm III), and at 9 months. (Arm III closed to accrual effective 07/23/2001.)

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 400 patients (133 per treatment arm) will be accrued for this study within 2 years. (Arm III closed to accrual effective 07/23/2001.)

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IVB, recurrent, or persistent carcinoma of the cervix that is not amenable to curative treatment with surgery and/or radiotherapy
  • Eligible subtypes:
  • Squamous cell carcinoma
  • Adenosquamous carcinoma
  • Adenocarcinoma
  • Measurable disease by physical examination, radiography, CT scan, or MRI
  • Measurable disease by CT scan/MRI without biopsy confirmation allowed if lesions are at least 3 cm and well defined
  • No craniospinal metastases

PATIENT CHARACTERISTICS: Age:

  • 18 and over

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • Bilirubin no greater than 1.5 times normal
  • SGOT no greater than 3 times normal
  • Alkaline phosphatase no greater than 3 times normal

Renal:

  • Creatinine no greater than 1.5 mg/dL
  • No bilateral hydronephrosis that cannot be alleviated by ureteral stents or percutaneous drainage

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No clinically significant infection
  • No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • Body surface area no greater than 2.0 m^2

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • Not specified

Chemotherapy:

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • See Chemotherapy
  • At least 3 weeks since prior radiotherapy only and recovered

Surgery:

  • Recovered from prior surgery

Other:

  • No prior anticancer treatment that would preclude study therapy

Location Information


Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States

Iowa
      Iowa Lutheran Hospital, Des Moines,  Iowa,  50316-2301,  United States

      John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines,  Iowa,  50309,  United States

      Mercy Cancer Center at Mercy Medical Center-Des Moines, Des Moines,  Iowa,  50314,  United States

Nebraska
      Midlands Cancer Center at Midlands Community Hospital, Papillion,  Nebraska,  68128-4157,  United States

New Mexico
      MBCCOP - University of New Mexico HSC, Albuquerque,  New Mexico,  87131,  United States

Pennsylvania
      Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033-0850,  United States

Wisconsin
      CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay,  Wisconsin,  54307-3453,  United States

Australia, New South Wales
      Westmead Hospital, Westmead,  New South Wales,  2145,  Australia

Peru
      Instituto de Enfermedades Neoplasicas, Lima,  34,  Peru

Puerto Rico
      San Juan City Hospital, San Juan,  00936-7344,  Puerto Rico

Study chairs or principal investigators

Harry J. Long, MD,  Study Chair,  Mayo Clinic Cancer Center   
Higinia R. Cardenes, MD, PhD,  Study Chair,  Indiana University Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067138; GOG-0179; ECOG-G0179
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003945
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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