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Clinical Trials (PDQ®)

Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompleted18 and overNCI, OtherCDR0000306463
GOG-0204, NCT00064077

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy such as cisplatin, paclitaxel, vinorelbine, gemcitabine, and topotecan, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen containing cisplatin is most effective in treating cervical cancer.

PURPOSE: This randomized phase III trial is studying four combination chemotherapy regimens using cisplatin to compare how well they work in treating women with stage IVB, recurrent, or persistent cancer of the cervix.

Further Study Information

OBJECTIVES:

  • Compare the survival and response of patients with stage IVB, recurrent, or persistent carcinoma of the cervix when treated with paclitaxel and cisplatin vs vinorelbine and cisplatin vs gemcitabine and cisplatin vs topotecan and cisplatin.
  • Compare the toxic effects of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms.

  • Arm I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.
  • Arm II: Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.
  • Arm III: Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.
  • Arm IV: Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.

In all arms, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before courses 2 and 5, and at 9 months after study entry.

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

PROJECTED ACCRUAL: A total of 600 patients (150 per treatment arm) will be accrued for this study within 4 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
  • Stage IVB, recurrent, or persistent disease
  • Not amenable to curative surgery and/or radiotherapy
  • At least 1 unidimensionally measurable lesion
  • At least 20 mm by palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by spiral CT scan
  • Biopsy confirmation required if lesion is less than 30 mm
  • Target lesion must be outside of a previously irradiated field
  • No craniospinal metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • GOG 0-1

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
  • Alkaline phosphatase no greater than 3 times normal
  • AST no greater than 3 times normal

Renal

  • Creatinine ≤ 1.2 mg/dL OR
  • Creatinine > 1.2 mg/dL but < 1.5 mg/dL AND creatinine clearance ≥ 50 mL/min
  • No bilateral hydronephrosis not alleviated by ureteral stents or percutaneous drainage

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No prior or concurrent malignancy within the past 5 years except nonmelanoma skin cancer
  • No prior malignancy whose treatment contraindicates the current study therapy
  • No concurrent clinically significant infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent cytokines

Chemotherapy

  • At least 6 weeks since prior chemoradiotherapy and recovered
  • No prior chemotherapy (except when concurrently administered with radiotherapy)

Endocrine therapy

  • Not specified

Radiotherapy

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

Surgery

  • Recovered from prior surgery

Trial Contact Information

Trial Lead Organizations/Sponsors

Gynecologic Oncology Group

National Cancer Institute

Bradley J. MonkStudy Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00064077
ClinicalTrials.gov processed this data on November 12, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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