CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Carboplatin +8 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/NCT01711541
NCT01711541Phase 2Completed

Carboplatin-Paclitaxel Induction Chemotherapy and ABT-888 (Veliparib) - a Phase 1/Randomized Phase 2 Study in Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck

National Cancer Institute (NCI)·interventional·Posted Oct 22, 2012·Updated Jun 7, 2023

In Brief

A Phase 2 clinical trial evaluating Carboplatin, Cisplatin, and 7 other interventions for Head and Neck Squamous Cell Carcinoma and 2 related conditions. Completed, enrolled 24 participants across 5 sites.

Detailed 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.

Study Details

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

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 22, 2012
Enrollment StartOct 22, 2012
Primary CompletionFeb 15, 2018
Study CompletionMay 15, 2023
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 13.7 years ago

Interventions

Carboplatindrug

Given IV

Cisplatindrug

Given IV

Fluorouracildrug

Given IV

Hydroxyureadrug

Given PO

Laboratory Biomarker Analysisother

Correlative studies

Paclitaxeldrug

Given IV

Placebo Administrationother

Given PO

Radiation Therapyradiation

Undergo radiation therapy

Veliparibdrug

Given PO