Triapine, Cisplatin, and Radiation Therapy in Treating Patients With Cervical Cancer or Vaginal Cancer
NCT00941070 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2017-11-17
Summary
This phase II trial is studying how triapine and cisplatin given together with radiation therapy works in treating patients with cervical cancer or vaginal cancer. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving triapine together with cisplatin may make tumor cells more sensitive to radiation therapy.
Conditions
- Recurrent Cervical Cancer
- Recurrent Vaginal Cancer
- Stage IB Cervical Cancer
- Stage II Vaginal Cancer
- Stage IIA Cervical Cancer
- Stage IIB Cervical Cancer
- Stage III Cervical Cancer
- Stage III Vaginal Cancer
- Stage IVA Cervical Cancer
- Stage IVA Vaginal Cancer
- Stage IVB Cervical Cancer
- Stage IVB Vaginal Cancer
- Therapy-related Toxicity
Interventions
- DRUG
-
triapine
Given IV
- DRUG
-
Given IV
- RADIATION
-
external beam radiation therapy
Undergo pelvic external beam radiation therapy
- PROCEDURE
-
quality-of-life assessment
Ancillary studies
- OTHER
-
questionnaire administration
Ancillary studies
- RADIATION
-
fludeoxyglucose F 18
Undergo FDG-PET/CT
- PROCEDURE
-
positron emission tomography
Undergo FDG-PET/CT
- PROCEDURE
-
computed tomography
Undergo FDG-PET/CT
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Charles Kunos · Case Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-07-31
- Primary Completion
- 2012-04-30
- Completion
- 2012-07-31
Countries
- United States
Study Locations
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