A Study of Pemetrexed and Folic Acid Given Before Surgery (Neoadjuvant Treatment) to Patients With Rectal Cancer.

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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 respectively changing due to cytotoxic treatment with Pemetrexed; To evaluate adverse events

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Folic Acid; Pemetrexed; Vitamin B Complex

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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• previously completed or withdrawn from this study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