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
- 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
- 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
- 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
- Patients with any other severe concurrent disease, which, in the judgment of the
investigator, would make the patient inappropriate for entry into this study.