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

This study has been terminated.
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00006224
First received: September 11, 2000
Last updated: April 10, 2013
Last verified: June 2005

September 11, 2000
April 10, 2013
September 2000
April 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00006224 on ClinicalTrials.gov Archive Site
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Gemcitabine in Treating Patients With Persistent or Recurrent Cancer of the Cervix
Evaluation of Gemcitabine in Persistent or Recurrent Non-Squamous Cell Carcinoma of the Cervix

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.

OBJECTIVES:

  • 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.

Interventional
Phase 2
Primary Purpose: Treatment
Cervical Cancer
Drug: gemcitabine hydrochloride
Not Provided
Schilder RJ, Blessing J, Cohn DE. Evaluation of gemcitabine in previously treated patients with non-squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2005 Jan;96(1):103-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
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April 2005   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

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

Renal:

  • Creatinine no greater than 1.5 mg/dL

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent filgrastim (G-CSF)

Chemotherapy:

  • 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

Radiotherapy:

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

Surgery:

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

Other:

  • No prior cancer treatment that would preclude study
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00006224
CDR0000068144, GOG-0128F
Not Provided
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Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Russell J. Schilder, MD Fox Chase Cancer Center
Gynecologic Oncology Group
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP