Study of Gemcitabine and Concurrent Radiation Followed by Adjuvant Hysterectomy in Bulky Stage Ib and IIa Cervical Carcinoma

NCT ID: NCT00184093

Last Updated: 2017-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-06-30
• Study Completion Date: 2009-05-31

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.

Conditions

Uterine Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemcitabine weekly x 6 wks with concurrent external radiation

Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

Gemcitabine weekly x 6 wks with concurrent external radiation

Interventions

Gemcitabine

Gemcitabine weekly x 6 wks with concurrent external radiation

Intervention Type: DRUG

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 > 100,000.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lynda Roman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

5C-99-1

Identifier Type: -

Identifier Source: org_study_id