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

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University of Southern California

Status and phase

Completed
Phase 2
Phase 1

Conditions

Uterine Cervical Cancer

Treatments

Drug: Gemcitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT00184093
5C-99-1

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

35 participants in 1 patient group

Gemcitabine weekly x 6 wks with concurrent external radiation
Experimental group
Description:
Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation
Treatment:
Drug: Gemcitabine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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