Clinical trial NCT00184093: Study of Gemcitabine and Concurrent Radiation Followed by Adjuvant Hysterectomy in Bulky Stage Ib and IIa Cervical Carcinoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Uterine Cervical Cancer
Keywords: Cervical Carcinoma
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Toxicity (Number of Participants With Serious Adverse Events)
timeFrame: Every 3 weeks from start of study until 30 days after the last dose of treatment
Secondary outcomes:
measure: Best Overall Response of Either a Complete Response (CR) or Partial Response (PR)
timeFrame: Baseline to response (up to 24 months)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Lynda Roman, MD
role: PRINCIPAL_INVESTIGATOR
References: