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Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer

NCT02595879 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-04-29

Study results available
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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.

Conditions

  • Advanced Cervical Adenocarcinoma
  • Advanced Cervical Adenosquamous Carcinoma
  • Advanced Cervical Squamous Cell Carcinoma
  • Advanced Vaginal Adenocarcinoma
  • Advanced Vaginal Adenosquamous Carcinoma
  • Advanced Vaginal Squamous Cell Carcinoma
  • Stage IB2 Cervical Cancer AJCC v6 and v7
  • Stage II Cervical Cancer AJCC v7
  • Stage II Vaginal Cancer AJCC v6 and v7
  • Stage III Vaginal Cancer AJCC v6 and v7
  • Stage IIIB Cervical Cancer AJCC v6 and v7
  • Stage IVA Cervical Cancer AJCC v6 and v7
  • Stage IVA Vaginal Cancer AJCC v6 and v7

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

RADIATION

Brachytherapy

Undergo LDR brachytherapy

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo FDG-PET/CT

RADIATION

External Beam Radiation Therapy

Undergo pelvic EBRT

OTHER

Fludeoxyglucose F-18

Undergo FDG-PET/CT

RADIATION

High-Dose Rate Brachytherapy

Undergo HDR brachytherapy

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

OTHER

Pharmacological Study

Correlative studies

PROCEDURE

Positron Emission Tomography

Undergo FDG-PET/CT

DRUG

Triapine

Given IV and PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Sarah E Taylor · University of Pittsburgh Cancer Institute LAO

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-18
Primary Completion
2023-06-04
Completion
2026-04-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02595879 on ClinicalTrials.gov