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A Phase II Trial of Proton Pump Inhibitors With Chemotherapy in Patients With Metastatic Head and Neck Cancer

NCT02013453 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-12-02

No results posted yet for this study

Summary

The purpose of this study is to determine if the addition of proton pump inhibitors (PPIs) to standard chemotherapy can improve progression free survival in patients with head and neck cancer.

Conditions

  • Cancer of Head and Neck

Interventions

DRUG

Omeprazole

40mg of Omeprazole will be administered daily by mouth.

DRUG

Carboplatin

Carboplatin will be administered over 30 minutes by continuous infusion.

DRUG

5FU

Administered by infusion.

DRUG

Paclitaxel

Administered by infusion.

DRUG

Pemetrexed

Administered by infusion.

Sponsors & Collaborators

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Francis Worden, M.D. · University of Michigan Rogel Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-12-31

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 NCT02013453 on ClinicalTrials.gov