Phase I/II Study of Gemcitabine and Concurrent Radiation Followed by Adjuvant Hysterectomy in Bulky Stage Ib and IIa Cervical Carcinoma: Analysis of Prognostic Factors and Determinants of Response: A Pilot Study

University of Southern California1 site in 1 country35 target enrollmentJune 1999

ConditionsUterine Cervical Cancer

InterventionsGemcitabine

DrugsGemcitabine

Overview

Phase: Phase 1
Intervention: Gemcitabine
Conditions: Uterine Cervical Cancer
Sponsor: University of Southern California
Enrollment: 35
Locations: 1
Primary Endpoint: Toxicity (Number of Participants With Serious Adverse Events)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is first to establish what is the ideal dose of gemcitabine, a chemotherapy agent, when given in combination with radiation. In addition, the investigators want to determine the side effects and the effectiveness of this combination. The investigators will also study several markers to try to identify markers or tests that will predict which patients will benefit more from this treatment.

Registry

clinicaltrials.gov

Start Date

June 1999

End Date

May 2009

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

University of Southern California

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with histologically confirmed bulky stage Ib or stage IIa cervical cancer. Bulky stage Ib disease is defined as tumor mass greater than 4 cms in diameter.
•Cervical lesion which is measurable by physical examination.
•No prior therapy for invasive cervical cancer.
•GOG performance status 0-2
•Signed informed consent
•Patients must have adequate:
•Bone marrow function: absolute granulocyte count \> or = to 1500, platelet count \> 100,
•Renal function: creatinine \< or = to 1.8 mg/dl
•Hepatic function: bilirubin \< or = to 1.5 x normal, SGOT and alkaline phosphatase \< or = to 3 x normal

Exclusion Criteria

•Patients with a history of prior malignancy, except adequately treated basal cell or squamous cell carcinoma of the skin, or other cancer for which the patient has been disease free for at least five years.
•Pregnant or lactating women. Women of reproductive age may not participate unless they have agreed to use an effective method of birth control.
•Patients with uncontrolled infection.
•Patients who are HIV positive
•Patients with psychiatric or social conditions that would interfere with consent or follow-up.
•Patients with any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.