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NCT02595879 · ClinicalTrials.gov registry record · Phase 1
Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer
A Phase 1 study of Advanced Cervical Adenocarcinoma and Advanced Vaginal Adenocarcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 17
- Study locations
NCT02595879: Active Phase 1 study of Advanced Cervical Adenocarcinoma and Advanced Vaginal Adenocarcinoma, sponsored by National Cancer Institute (NCI).
NCT02595879 is a Phase 1 study of Advanced Cervical Adenocarcinoma and Advanced Vaginal Adenocarcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). The trial reports 17 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02595879, a Phase 1 study of Advanced Cervical Adenocarcinoma and Advanced Vaginal Adenocarcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 17
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of triapine when given with radiation therapy and cisplatin in treating patients with stage IB2-IVA cervical or vaginal cancer. Triapine may stop the growth of cancer cells by blocking an enzyme needed for cell growth. Cisplatin is a drug used in chemotherapy that kills cancer cells by damaging their deoxyribonucleic acid (DNA) and stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Adding triapine to standard treatment with cisplatin and radiation therapy may kill more cancer cells.
Primary Outcome
The MTD was determined following a standard 3+3 design is as follows: Escalation at 0/3 DLTs, dose-reduction if \>1/3 DLT, and expansion to 6 if 1/3 DLTs. DLT is defined as the severe toxicity event that leads to the termination of the treatment as defined in section 5.5. The highest dose level where \<2/6 DLTs are observed will be declared MTD
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Cisplatin
- RADIATION External Beam Radiation Therapy
- RADIATION Brachytherapy
Study Locations (17)
Kansas
- University of Kansas Clinical Research Center - Fairway
- University of Kansas Cancer Center - Kansas City
- University of Kansas Hospital-Indian Creek Campus - Overland Park
- University of Kansas Hospital-Westwood Cancer Center - Westwood
California
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Keck Medical Center of USC Pasadena - Pasadena
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
- Wayne State University/Karmanos Cancer Institute - Detroit
- Weisberg Cancer Treatment Center - Farmington Hills
Virginia
- University of Virginia Cancer Center - Charlottesville
- VCU Massey Comprehensive Cancer Center - Richmond
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Kentucky
- University of Kentucky/Markey Cancer Center - Lexington
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2019-09-18 |
| Est. Completion | 2026-04-29 |
| Phase | Phase 1 |
What the registry record for NCT02595879 still lists
NCT02595879 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 10 conditions, with Advanced Cervical Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT02595879 lists 17 locations in 9 states (Kansas, California, Michigan).
Frequently Asked Questions
What is clinical trial NCT02595879 about?
NCT02595879 is a clinical study titled "Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer". This phase I trial studies the side effects and best dose of triapine when given with radiation therapy and cisplatin in treating patients with stage IB2-IVA cervical or vaginal cancer. Triapine may stop the growth of cancer cells by blocking an enzyme needed for cell growth. Cisplatin is a drug use...
What is the current status of trial NCT02595879?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2019-09-18. Estimated completion is 2026-04-29.
What conditions does trial NCT02595879 study?
This clinical trial studies the following conditions: Advanced Cervical Adenocarcinoma, Advanced Vaginal Adenocarcinoma, Advanced Vaginal Adenosquamous Carcinoma, Advanced Vaginal Squamous Cell Carcinoma, Stage IB2 Cervical Cancer AJCC v6 and v7.
What interventions are being tested in trial NCT02595879?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Cisplatin (DRUG), External Beam Radiation Therapy (RADIATION), Brachytherapy (RADIATION).
Who is sponsoring clinical trial NCT02595879?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02595879 being conducted?
This trial has 17 study locations across Alabama, California, Kansas, Kentucky, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02595879's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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