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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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