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

Phase 2
Not Enrolling
Cervical Cancer

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Trial Information

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


- 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.

Inclusion Criteria


- 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



- Not specified

Performance status:

- GOG 0-2

Life expectancy:

- Not specified


- Platelet count at least lower limit of normal

- Absolute neutrophil count at least 1,500/mm^3


- Bilirubin no greater than 1.5 times normal

- SGOT and alkaline phosphatase no greater than 3 times normal


- Creatinine no greater than 2.0 mg/dL


- Not pregnant

- Fertile patients must use effective contraception

- No significant infection

- No other malignancies within past 5 years except nonmelanoma skin cancer


Biologic therapy:

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


- 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


- At least 3 weeks since prior radiotherapy for cervical cancer and recovered

- No prior radiotherapy to more than 25% of marrow-bearing areas


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


- No concurrent amifostine or other protective reagents

- No prior anticancer therapy that contraindicates study

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Cheryl A. Brewer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Illinois College of Medicine at Peoria


United States: Federal Government

Study ID:




Start Date:

October 2000

Completion Date:

Related Keywords:

  • Cervical Cancer
  • recurrent cervical cancer
  • stage IVB cervical cancer
  • stage IVA cervical cancer
  • cervical squamous cell carcinoma
  • Carcinoma, Squamous Cell
  • Uterine Cervical Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Chao Family Comprehensive Cancer Center Orange, California  92868
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Rush-Presbyterian-St. Luke's Medical Center Chicago, Illinois  60612
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Cooper Hospital/University Medical Center Camden, New Jersey  08103
Cancer Center of Albany Medical Center Albany, New York  12208
State University of New York Health Science Center at Brooklyn Brooklyn, New York  11203
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Ireland Cancer Center Cleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
University of Oklahoma College of Medicine Oklahoma City, Oklahoma  73190
Abington Memorial Hospital Abington, Pennsylvania  19001
Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
Tacoma General Hospital Tacoma, Washington  98405
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
Community Hospital of Los Gatos Los Gatos, California  95032
Tufts University School of Medicine Boston, Massachusetts  02111
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Cancer Center at the University of Virginia Charlottesville, Virginia  22908
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Schneider Children's Hospital at North Shore Manhasset, New York  11030
Rational Therapeutics Inc. Long Beach, California  90807
University of Illinois College of Medicine at Peoria Peoria, Illinois  61603