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

Uterine Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00184093
• Other study ID #: 5C-99-1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 12, 2005
• Last updated: May 20, 2014
• Start date: June 1999
• Est. completion date: May 2009

Study information

• Verified date: May 2014
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 2009
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Uterine Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Gemcitabine
Gemcitabine weekly x 6 wks with concurrent external radiation

Locations

Country	Name	City	State
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity		after 6 weeks	Yes
Secondary	Response		After 6 weeks	No