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A Study for Patients With Head and Neck Cancer

NCT00415194 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 795

Last updated 2011-06-28

Study results available
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Summary

This study will compare the effects of pemetrexed plus cisplatin versus cisplatin alone in head and neck cancer patients.

Conditions

  • Head and Neck Neoplasms

Interventions

DRUG

pemetrexed

500 mg/m\^2, IV, every 21 days, six 21 day cycles

DRUG

cisplatin

75 mg/m\^2, administered IV, every 21 days, six 21 day cycles

DRUG

placebo

Approximately 100 mL normal saline administered IV, every 21 days, six 21 day cycles

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • China
  • Denmark
  • France
  • Germany
  • Hungary
  • India
  • Italy
  • Mexico
  • Netherlands
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00415194 on ClinicalTrials.gov