NCT02013453

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

A Phase II Randomized Trial Evaluating the Use of Proton Pump Inhibitors (PPIs) in Conjunction With Chemotherapy, in Patients With Recurrent Unresectable or Metastatic Cancers of the Head and Neck

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2013-12-01
• Primary completion: 2016-12-01
• First posted: 2013-12-17
• Last updated: 2014-12-02

Locations

1 site across 1 country: United States