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

Cervical Cancer Clinical Trial

Official title:

A Phase II Evaluation Of Gemcitabine And Cisplatin In Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00006482
• Other study ID #: CDR0000068313
• Secondary ID: GOG-0127Q
• Status: Terminated
• Phase: Phase 2
• First received: November 6, 2000
• Last updated: April 10, 2013
• Start date: October 2000

Study information

• Verified date: May 2004
• 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• cisplatin

• 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	Roswell Park Cancer Institute	Buffalo	New York
United States	Cooper Hospital/University Medical Center	Camden	New Jersey
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North 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	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	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	Simmons Cancer Center - Dallas	Dallas	Texas
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	University of Mississippi Medical Center	Jackson	Mississippi
United States	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky
United States	Rational Therapeutics Inc.	Long Beach	California
United States	Community Hospital of Los Gatos	Los Gatos	California
United States	Schneider Children's Hospital at North Shore	Manhasset	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma
United States	Chao Family Comprehensive Cancer Center	Orange	California
United States	University of Illinois College of Medicine at Peoria	Peoria	Illinois
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
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)

Brewer CA, Blessing JA, Nagourney RA, McMeekin DS, Lele S, Zweizig SL. Cisplatin plus gemcitabine in previously treated squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2006 Feb;100(2):385-8. Epub 2 — View Citation