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

NCT00006482 | Terminated Phase 2

• 2 other identifiers: CDR0000068313GOG-0127Q
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 34

Brief 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.

Conditions

Cervical Cancer

Keywords

recurrent cervical cancer; stage IVB cervical cancer; stage IVA cervical cancer; cervical squamous cell carcinoma

Interventions

cisplatin DRUG

gemcitabine hydrochloride DRUG

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (34)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

Rational Therapeutics Inc.

Long Beach, California, 90807, United States

Location

Community Hospital of Los Gatos

Los Gatos, California, 95032, United States

Location

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5000, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

University of Illinois College of Medicine at Peoria

Peoria, Illinois, 61603, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, 40536-0084, United States

Location

Tufts University School of Medicine

Boston, Massachusetts, 02111, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Cooper Hospital/University Medical Center

Camden, New Jersey, 08103, United States

Location

Cancer Center of Albany Medical Center

Albany, New York, 12208, United States

Location

State University of New York Health Science Center at Brooklyn

Brooklyn, New York, 11203, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Schneider Children's Hospital at North Shore

Manhasset, New York, 11030, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Barrett Cancer Center, The University Hospital

Cincinnati, Ohio, 45267-0502, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

University of Oklahoma College of Medicine

Oklahoma City, Oklahoma, 73190, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

Cancer Center at the University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Tacoma General Hospital

Tacoma, Washington, 98405, United States

Location

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Related 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. doi: 10.1016/j.ygyno.2005.09.009. Epub 2005 Nov 4.

  PMID: 16271750 RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Cheryl A. Brewer, MD

  University of Illinois College of Medicine at Peoria

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 6, 2000
• First Posted: October 8, 2003
• Study Start: October 1, 2000
• Primary Completion: April 1, 2006
• Last Updated: April 11, 2013

Record last verified: 2004-05

Locations

CA (1); US (33)