Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers

Summary

This randomized phase III trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and cisplatin are more effective with triapine in treating cervical or vaginal cancer.

Conditions

• Advanced Vaginal Adenocarcinoma
• Advanced Vaginal Adenosquamous Carcinoma
• Advanced Vaginal Squamous Cell Carcinoma
• Cervical Adenocarcinoma
• Cervical Adenosquamous Carcinoma
• Cervical 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 IIA Cervical Cancer AJCC v7
• Stage IIB Cervical Cancer AJCC v6 and v7
• Stage III Vaginal Cancer AJCC v6 and v7
• Stage IIIB Cervical Cancer AJCC v6 and v7
• Stage IV Vaginal Cancer AJCC v6 and v7
• Stage IVA Cervical Cancer AJCC v6 and v7
• Stage IVA Vaginal Cancer AJCC v6 and v7
• Unresectable Vaginal Carcinoma
• Vaginal Adenocarcinoma
• Vaginal Adenosquamous Carcinoma
• Vaginal Carcinoma
• Vaginal Squamous Cell Carcinoma, Not Otherwise Specified

Interventions

RADIATION

Brachytherapy

Undergo brachytherapy

DRUG

Cisplatin

Given IV

RADIATION

External Beam Radiation Therapy

Undergo EBRT

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

OTHER

Laboratory Biomarker Analysis

Correlative studies

RADIATION

Radiation Therapy

Undergo conventional RT

DRUG

Triapine

Given IV

Sponsors & Collaborators

• NRG Oncology

  collaborator OTHER

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Charles A Leath · NRG Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-05-10

Primary Completion

2023-01-26

Completion

2026-07-14

FDA Drug

Yes

Countries

• United States
• Canada
• Puerto Rico

Study Locations