CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
triapine +7 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00941070
NCT00941070Phase 2Completed
CompareCT.gov

A Phase 2 Study of Triapine® (NSC #663249) and Cisplatin in Combination With Pelvic Radiation for Treatment of Stage IB2-IVa Cervical Cancer or Stage II-IV Vaginal Cancer

National Cancer Institute (NCI)·interventional·Posted Jul 17, 2009·Updated Nov 17, 2017

In Brief

A Phase 2 clinical trial evaluating triapine, cisplatin, and 6 other interventions for Recurrent Cervical Cancer and 12 related conditions. Completed, enrolled 26 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent 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
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 17, 2009
Enrollment StartJul 1, 2009
Primary CompletionApr 1, 2012
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.0 years ago

Interventions

triapinedrug

Given IV

cisplatindrug

Given IV

external beam radiation therapyradiation

Undergo pelvic external beam radiation therapy

quality-of-life assessmentprocedure

Ancillary studies

questionnaire administrationother

Ancillary studies

fludeoxyglucose F 18radiation

Undergo FDG-PET/CT

positron emission tomographyprocedure

Undergo FDG-PET/CT

computed tomographyprocedure

Undergo FDG-PET/CT