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

A Feasibility Study of Pemetrexed Single Agent and Folic Acid Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer

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

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• previously completed or withdrawn from this study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