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Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IV Head and Neck Cancer

NCT01711541 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-06-07

Study results available
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Summary

This partially randomized phase I/II trial studies the side effects and best dose of veliparib when given together with combination chemotherapy and to see how well they work in treating patients with stage IV head and neck cancer. Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, 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. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective when given with or without veliparib in treating head and neck cancer.

Conditions

Interventions

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

DRUG

Fluorouracil

Given IV

DRUG

Hydroxyurea

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Paclitaxel

Given IV

OTHER

Placebo Administration

Given PO

RADIATION

Radiation Therapy

Undergo radiation therapy

DRUG

Veliparib

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Jonas De Souza · Alliance for Clinical Trials in Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-22
Primary Completion
2018-02-15
Completion
2023-05-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01711541 on ClinicalTrials.gov