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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Uterine Cervical Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Toxicity

Outcome Time Frame:

after 6 weeks

Safety Issue:

Yes

Principal Investigator

Lynda Roman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

5C-99-1

NCT ID:

NCT00184093

Start Date:

June 1999

Completion Date:

May 2008

Related Keywords:

  • Uterine Cervical Cancer
  • Cervical Carcinoma
  • Carcinoma
  • Uterine Cervical Neoplasms

Name

Location

USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800