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Gemcitabine and Cisplatin in Treating Patients With Refractory or Recurrent Cancer of the Cervix

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ClinicalTrials.gov Identifier: NCT00006482
Recruitment Status : Terminated
First Posted : October 8, 2003
Last Update Posted : April 11, 2013
National Cancer Institute (NCI)
Information provided by:
Gynecologic Oncology Group

Brief Summary:

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.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and cisplatin in treating patients who have refractory or recurrent cancer of the cervix.

Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: cisplatin Drug: gemcitabine hydrochloride Phase 2

Detailed Description:


  • Determine the antitumor activity of gemcitabine and cisplatin in patients with refractory or recurrent squamous cell carcinoma of the cervix.
  • Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive cisplatin IV and gemcitabine IV over 1 hour on days 1 and 8. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 28-69 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Evaluation Of Gemcitabine And Cisplatin In Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix
Study Start Date : October 2000
Primary Completion Date : April 2006

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed refractory or recurrent squamous cell carcinoma of the cervix that has failed local therapy and is considered incurable
  • Must have had 1 prior chemotherapy regimen for cervical cancer

    • No more than 1 prior chemotherapy regimen (single or combination drug therapy), unless used as a radiosensitizer
    • No prior chemotherapy for recurrent or persistent disease including retreatment with initial chemotherapy
  • Bidimensionally measurable disease
  • Ineligible for higher priority GOG protocol



  • Not specified

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified


  • Platelet count at least lower limit of normal
  • Absolute neutrophil count at least 1,500/mm^3


  • Bilirubin no greater than 1.5 times normal
  • SGOT and alkaline phosphatase no greater than 3 times normal


  • Creatinine no greater than 2.0 mg/dL


  • Not pregnant
  • Fertile patients must use effective contraception
  • No significant infection
  • No other malignancies within past 5 years except nonmelanoma skin cancer


Biologic therapy:

  • At least 3 weeks since prior biologic therapy for cervical cancer


  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy for cervical cancer and recovered
  • No prior gemcitabine

Endocrine therapy:

  • At least 3 weeks since prior endocrine therapy for cervical cancer


  • At least 3 weeks since prior radiotherapy for cervical cancer and recovered
  • No prior radiotherapy to more than 25% of marrow-bearing areas


  • At least 3 weeks since prior surgery for cervical cancer and recovered


  • No concurrent amifostine or other protective reagents
  • No prior anticancer therapy that contraindicates study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006482

  Show 34 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Cheryl A. Brewer, MD University of Illinois College of Medicine at Peoria

ClinicalTrials.gov Identifier: NCT00006482     History of Changes
Other Study ID Numbers: CDR0000068313
First Posted: October 8, 2003    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: May 2004

Keywords provided by Gynecologic Oncology Group:
recurrent cervical cancer
stage IVB cervical cancer
stage IVA cervical cancer
cervical squamous cell carcinoma

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs