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Gemcitabine in Treating Patients With Persistent or Recurrent Cancer of the Cervix

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006224
Recruitment Status : Terminated
First Posted : November 11, 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.

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

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

Detailed Description:


  • Determine the antitumor activity of gemcitabine in patients with persistent or recurrent nonsquamous cell carcinoma of the cervix who failed higher priority treatment protocols.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Courses repeat every 4 weeks 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: Approximately 15-37 patients will be accrued for this study within 1 year.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Evaluation of Gemcitabine in Persistent or Recurrent Non-Squamous Cell Carcinoma of the Cervix
Study Start Date : September 2000
Primary Completion Date : April 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Diagnosis of persistent or recurrent nonsquamous cell carcinoma of the cervix that has failed local therapeutic measures and is considered incurable

    • Eligible subtypes:

      • Adenocarcinoma
      • Adenosquamous carcinoma
      • Undifferentiated carcinoma
    • Must have documented disease progression
    • Histologic confirmation of original primary tumor required
  • Bidimensionally measurable disease
  • Ineligible for higher priority GOG protocol



  • 18 and over

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified


  • Platelet count at least 100,000/mm^3
  • Granulocyte 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 1.5 mg/dL


  • No significant infection
  • Not pregnant
  • Fertile patients must use effective contraception
  • No other invasive malignancy within the past 5 years except nonmelanomatous skin cancer


Biologic therapy:

  • No concurrent filgrastim (G-CSF)


  • No prior gemcitabine
  • At least 3 weeks since other prior chemotherapy for cervical cancer and recovered
  • No more than 1 prior chemotherapy regimen (single or combination cytotoxic therapy)

Endocrine therapy:

  • Not specified


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


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


  • No prior cancer treatment that would preclude 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 identifier (NCT number): NCT00006224

  Show 39 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Russell J. Schilder, MD Fox Chase Cancer Center

Publications of Results: Identifier: NCT00006224     History of Changes
Other Study ID Numbers: CDR0000068144
First Posted: November 11, 2003    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: June 2005

Keywords provided by Gynecologic Oncology Group:
recurrent cervical cancer
cervical adenocarcinoma
cervical adenosquamous 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
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs