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

Cervical Cancer Clinical Trial

Official title:

Evaluation of Gemcitabine in Persistent or Recurrent Non-Squamous Cell Carcinoma of the Cervix

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00006224
• Other study ID #: CDR0000068144
• Secondary ID: GOG-0128F
• Status: Terminated
• Phase: Phase 2
• First received: September 11, 2000
• Last updated: April 10, 2013
• Start date: September 2000

Study information

• Verified date: June 2005
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Center - Calgary	Calgary	Alberta
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Cancer Center of Albany Medical Center	Albany	New York
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Tufts University School of Medicine	Boston	Massachusetts
United States	State University of New York Health Science Center at Brooklyn	Brooklyn	New York
United States	Fletcher Allen Health Care - Medical Center Campus	Burlington	Vermont
United States	Cooper Hospital/University Medical Center	Camden	New Jersey
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cancer Center at the University of Virginia	Charlottesville	Virginia
United States	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Barrett Cancer Center, The University Hospital	Cincinnati	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Ellis Fischel Cancer Center	Columbia	Missouri
United States	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	Simmons Cancer Center - Dallas	Dallas	Texas
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Holden Comprehensive Cancer Center at The University of Iowa	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	Community Hospital of Los Gatos	Los Gatos	California
United States	Brookview Research, Inc.	Nashville	Tennessee
United States	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma
United States	Chao Family Comprehensive Cancer Center	Orange	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Tacoma General Hospital	Tacoma	Washington
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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. — View Citation