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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



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University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Cooper Hospital/University Medical CenterCamden, New Jersey  08103
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State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
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Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Simmons Cancer Center - DallasDallas, Texas  75235-9154
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University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Community Hospital of Los GatosLos Gatos, California  95032
Tufts University School of MedicineBoston, Massachusetts  02111
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Schneider Children's Hospital at North ShoreManhasset, New York  11030
Rational Therapeutics Inc.Long Beach, California  90807
University of Illinois College of Medicine at PeoriaPeoria, Illinois  61603