Status:

COMPLETED

Study of Pemetrexed in the Treatment of Patients With Ovarian Cancer Who Have Failed Prior Platinum-Based Chemotherapy

Lead Sponsor:

Eli Lilly and Company

Conditions:

Ovarian Neoplasms

Primary Peritoneal Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief Summary

The purposes of this study are to determine: - whether standard or higher doses of pemetrexed should be given to patients with ovarian or primary peritoneal cancer that has recurred; - the safety and ...

Eligibility Criteria

Inclusion

  • Patient must have been diagnosed with ovarian or primary peritoneal cancer
  • Patient must have had 1 or 2 prior platinum-based chemotherapeutic regimens.
  • Patient must have adequate health status.
  • Patient compliance and geographic proximity that allow for adequate follow up is required.
  • Signed informed consent from the patient or legal representative is required.

Exclusion

  • Patient is pregnant or breast-feeding
  • Patient has received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  • Patient has previously participated in another study investigating pemetrexed.
  • Patient is unable or unwilling to take folic acid, vitamin B12 supplementation, and corticosteroids.
  • Patient cannot be taking nonsteroidal anti-inflammatory drugs around the time of administration of study drug.

Key Trial Info

Start Date :

June 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2007

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00109096

Start Date

June 1 2005

End Date

March 1 2007

Last Update

May 17 2007

Active Locations (21)

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Page 1 of 6 (21 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.

Brussels, Belgium

2

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

Leuven, Belgium

3

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

Berlin, Germany

4

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

Erlangen, Germany