Status:
COMPLETED
A Study of Pemetrexed and Folic Acid Given Before Surgery (Neoadjuvant Treatment) to Patients With Rectal Cancer.
Lead Sponsor:
Eli Lilly and Company
Conditions:
Rectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to help answer the following research questions: If the study drug Pemetrexed can help patients with rectal cancer; If molecular biological parameters are correlated resp...
Eligibility Criteria
Inclusion
- no prior therapy for rectal cancer
- pathological/ cytological diagnosis of adenocarcinoma of the rectum. Patients must have operable rectal cancer that is amenable to surgery.
- adequate organ function
- Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1
- signed informed consent
- at least 18 years of age
- surgically sterile, postmenopausal (women) or compliant with a medically approved contraceptive regimen during and for 6 months after the treatment.
Exclusion
- concurrent administration of any other anti-tumor therapy
- treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
- serious concomitant systemic disorders
- previously completed or withdrawn from this study
- pregnant or breast-feeding
- second primary malignancy
- history of significant neurological or mental disorder, including seizures or dementia
- inability to interrupt aspirin or other nonsteroidal anto-inflammatory drugs (NSAIDs)
- presence of clinically relevant third space fluid collections that cannot be controlled by drainage or other procedure prior to the study entry
- inability or unwillingness to take folic acid, vitamin B12 or dexamethasone
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00330915
Start Date
June 1 2006
End Date
June 1 2008
Last Update
July 21 2009
Active Locations (1)
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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.
Gothenburg, Sweden, 41685