Status:

COMPLETED

A Study for Patients With Head and Neck Cancer

Lead Sponsor:

Eli Lilly and Company

Conditions:

Head and Neck Neoplasms

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

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

Eligibility Criteria

Inclusion

  • You must have head and neck cancer that has returned and cannot be treated with surgery or other types of treatment. OR You must have head and neck cancer that was just found and has spread to other parts of your body.
  • You must have a performance status of 0,1 or 2. This means that you must at least be able to get around, be able to take care of yourself and must be up and about most of the day.
  • Your test results must show that your liver, kidneys and blood cells are working normally.
  • You must understand and sign the form that gives your agreement to willingly be part of the study.
  • You must be at least 18 years of age.

Exclusion

  • You cannot have previously been given other treatment for cancer that has spread to other parts of your body.
  • You cannot have a serious sickness that might keep you from finishing the study (for example a bad infection).
  • You cannot have any extra fluid in your chest or bowel area unless your doctor tells you it can be drained before you join the study.
  • You cannot have any cancer called nasopharyngeal cancer, paranasal sinus cancer, lip cancer, or salivary gland cancer.
  • If you are taking high dose aspirin or other medicines called non-steroidal anti-inflammatory drugs and cannot stop taking them for at least 5 days, you cannot be in the study. Your doctor or a member of the study team can explain which drugs are non-steroidal anti-inflammatory drugs.

Key Trial Info

Start Date :

December 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2010

Estimated Enrollment :

795 Patients enrolled

Trial Details

Trial ID

NCT00415194

Start Date

December 1 2006

End Date

March 1 2010

Last Update

June 28 2011

Active Locations (94)

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Page 1 of 24 (94 locations)

1

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Orange, California, United States, 92868

2

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Orlando, Florida, United States, 32806

3

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

St. Petersburg, Florida, United States, 33708

4

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Atlanta, Georgia, United States, 30322