Phase 2
N=35
Study of Gemcitabine and Concurrent Radiation Followed by Adjuvant Hysterectomy in Bulky Stage Ib and IIa Cervical Carcinoma
Uterine Cervical Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00184093 ↗Enrolled (actual)
35
Serious AEs
28.6%
Results posted
Aug 2017
Primary outcome: Primary: Toxicity (Number of Participants With Serious Adverse Events) — 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gemcitabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Southern California
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Toxicity (Number of Participants With Serious Adverse Events) |
10 | — |
| SECONDARY Best Overall Response of Either a Complete Response (CR) or Partial Response (PR) |
32 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00184093). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.