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Gemcitabine in Treating Patients With Persistent or Recurrent Cancer of the Cervix
This study has been completed.
First Received: September 11, 2000   Last Updated: October 12, 2008   History of Changes
Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006224
  Purpose

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 Intervention Phase
Cervical Cancer
Drug: gemcitabine hydrochloride
Phase II

MedlinePlus related topics: Cancer Cervical Cancer
Drug Information available for: Gemcitabine Gemcitabine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Evaluation of Gemcitabine in Persistant or Recurrent Non-Squamous Cell Carcinoma of the Cervix

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2000
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006224

  Show 39 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Russell J. Schilder, MD Fox Chase Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000068144, GOG-0128F
Study First Received: September 11, 2000
Last Updated: October 12, 2008
ClinicalTrials.gov Identifier: NCT00006224     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent cervical cancer
cervical adenocarcinoma
cervical adenosquamous cell carcinoma

Study placed in the following topic categories:
Antimetabolites
Immunologic Factors
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Immunosuppressive Agents
Antiviral Agents
Recurrence
Carcinoma
Uterine Cervical Neoplasms
Genital Diseases, Female
Uterine Cervical Diseases
Radiation-Sensitizing Agents
Uterine Neoplasms
Adenocarcinoma
Gemcitabine
Carcinoma, Adenosquamous

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

ClinicalTrials.gov processed this record on May 06, 2009