A Study for Participants With Recurrent or Metastatic Squamous Cell Head and Neck Cancer

NCT01087970 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2014-05-19

Study results available
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Summary

The purpose of this study is to look for an improvement in progression free survival with the combination of pemetrexed, carboplatin (or cisplatin) and cetuximab in participants with recurrent or metastatic squamous cell carcinoma of the head and neck.

Conditions

  • Head and Neck Neoplasms

Interventions

DRUG

Pemetrexed

Administered intravenously, for maximum of 6 cycles.

DRUG

Cetuximab

Administered intravenously in combination therapy, for a maximum of 6 cycles. After the completion of 6 cycles, participants who have not experienced disease progression will continue on cetuximab monotherapy until disease progression.

DRUG

Carboplatin

Administered intravenously, for a maximum of 6 cycles

DRUG

Cisplatin

Administered intravenously, for a maximum of 6 cycles

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States

Study Locations

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Entities

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 NCT01087970 on ClinicalTrials.gov