Status:
COMPLETED
Phase 2 Study on Use of a Combination of Pemetrexed in Patients With Advanced Gastric Carcinoma
Lead Sponsor:
Eli Lilly and Company
Conditions:
Gastrointestinal Neoplasms
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Pemetrexed has shown an anti-tumor activity in advanced gastric cancer patients in a previous study, while cisplatin is widely used in the combination chemotherapy of gastric cancer. Pemetrexed has sh...
Eligibility Criteria
Inclusion
- diagnosis of adenocarcinoma of the stomach
- Stage IV disease not amenable to curative surgery.
- Disease status must be that of measurable disease as defined by RECIST criteria
- Performance Status of 0 or 1 on the ECOG Scale and adequate organ function.
- Signed informed consent from patient
Exclusion
- Prior palliative chemotherapy for advanced disease.
- Known or suspected brain metastasis or Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- Concurrent administration of any other tumor therapy
- Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of ALIMTA plus cisplatin.
- Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00190801
Start Date
September 1 2003
End Date
September 1 2005
Last Update
January 26 2007
Active Locations (3)
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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 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Goyang-si, South Korea
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 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Incheon, South Korea
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 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seoul, South Korea