Status:

COMPLETED

Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen

Lead Sponsor:

Eli Lilly and Company

Conditions:

Non-small Cell Lung Cancer

Mesothelioma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

This study will test the effects of pemetrexed on mesothelioma and non-small cell lung cancer patients with fluid around their lungs or abdomen.

Eligibility Criteria

Inclusion

  • Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell lung cancer (NSCLC) or mesothelioma
  • Presence of third-space fluid (fluid around the lungs or abdomen).
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1.
  • Prior anticancer treatment (except radiation) must be completed at least 3 weeks prior to study enrollment, and the patient must have recovered from the sharp toxic effects the anticancer treatment.
  • Estimated life expectancy of at least 8 weeks.

Exclusion

  • Have received treatment within the last 30 days with a drug that was not a marketed product.
  • Active infection that, in the opinion of the investigator, would not allow the patient to tolerate therapy.
  • Pregnancy.
  • Breast-feeding.
  • Significant weight loss (that is, greater than or equal to 10% of body weight) over the 6 weeks before study entry.
  • Brain metastases.

Key Trial Info

Start Date :

December 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2009

Estimated Enrollment :

31 Patients enrolled

Trial Details

Trial ID

NCT00316225

Start Date

December 1 2006

End Date

March 1 2009

Last Update

July 9 2010

Active Locations (3)

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Page 1 of 1 (3 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.

Copenhagen, Denmark, 2100

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.

Hanover, Germany, 30625

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.

Madrid, Spain, 28041