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

Phase 2
18 Years
Not Enrolling
Cervical Cancer

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Trial Information

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


- Determine the antitumor activity of gemcitabine in patients with persistent or
recurrent nonsquamous cell carcinoma of the cervix who failed higher priority treatment

- 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

Inclusion Criteria


- 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



- 18 and over

Performance status:

- GOG 0-2

Life expectancy:

- Not specified


- Platelet count at least 100,000/mm^3

- Granulocyte 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 1.5 mg/dL


- No significant infection

- Not pregnant

- Fertile patients must use effective contraception

- No other invasive malignancy within the past 5 years except nonmelanomatous skin


Biologic therapy:

- No concurrent filgrastim (G-CSF)


- 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


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


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


- No prior cancer treatment that would preclude study

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Russell J. Schilder, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Federal Government

Study ID:




Start Date:

September 2000

Completion Date:

Related Keywords:

  • Cervical Cancer
  • recurrent cervical cancer
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • Uterine Cervical Neoplasms



Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
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
University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Washington University School of Medicine Saint Louis, Missouri  63110
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
Medical University of South Carolina Charleston, South Carolina  29425-0721
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
Tacoma General Hospital Tacoma, Washington  98405
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
Community Hospital of Los Gatos Los Gatos, California  95032
Holden Comprehensive Cancer Center at The University of Iowa Iowa City, Iowa  52242-1009
Tufts University School of Medicine Boston, Massachusetts  02111
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Brookview Research, Inc. Nashville, Tennessee  37203
Cancer Center at the University of Virginia Charlottesville, Virginia  22908
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
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Ellis Fischel Cancer Center Columbia, Missouri  65203