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

This study has been terminated.
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00006482
First received: November 6, 2000
Last updated: April 10, 2013
Last verified: May 2004
  Purpose

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 Intervention Phase
Cervical Cancer
Drug: cisplatin
Drug: gemcitabine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Evaluation Of Gemcitabine And Cisplatin In Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Study Start Date: October 2000
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Platelet count at least lower limit of normal
  • Absolute neutrophil 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 2.0 mg/dL

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • 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

Radiotherapy:

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

Surgery:

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

Other:

  • No concurrent amifostine or other protective reagents
  • No prior anticancer therapy that contraindicates study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006482

  Show 34 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Cheryl A. Brewer, MD University of Illinois College of Medicine at Peoria
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00006482     History of Changes
Other Study ID Numbers: CDR0000068313, GOG-0127Q
Study First Received: November 6, 2000
Last Updated: April 10, 2013
Health Authority: United States: Federal Government

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:
Carcinoma, Squamous Cell
Uterine Cervical Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 28, 2014