Trial for First-Line Treatment of Colorectal Cancer

In this study, patients will receive either ALIMTA (pemetrexed) plus irinotecan or 5-fluorouracil (5-FU), leucovorin, and irinotecan. The purposes of this study are to determine:

How ALIMTA plus irinotecan compares with 5-FU, leucovorin, and irinotecan in terms of efficacy.
The safety of ALIMTA plus irinotecan and any side effects that might be associated with it as compared with 5-FU, leucovorin, and irinotecan.

Whether ALIMTA can help patients with colorectal cancer.

In this study, patients will receive either ALIMTA (pemetrexed) plus irinotecan or 5-fluorouracil (5-FU), leucovorin, and irinotecan. The purposes of this study are to determine: How ALIMTA plus irinotecan compares with 5-FU, leucovorin, and irinotecan in terms of efficacy. The safety of ALIMTA plus irinotecan and any side effects that might be associated with it as compared with 5-FU, leucovorin, and irinotecan. Whether ALIMTA can help patients with colorectal cancer. Condition:- Colorectal Cancer Study Type: InterventionalStudy Design: Treatment, Randomized Official Title: A Randomized Phase 2 Trial for First-Line Treatment of Colorectal Cancer Eligibility Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both Criteria Inclusion Criteria:The patient must have:Histologic or cytologic diagnosis of adenocarcinoma of the colon or rectum. Performance status of 0 to 2 on the ECOG Performance Status Scale. Standard postoperative adjuvant radiation therapy for rectal cancer is allowed. Locally advanced or metastatic disease. Must be 18 years of age. Exclusion Criteria:The patient must not have:Received prior chemotherapy for advanced disease. Prior adjuvant therapy, including 5-FU, is allowed if it has been more than 12 months since the last treatment. Received prior treatment with irinotecan in the adjuvant setting. Are unable to take vitamin B12 or folic acid. Are unable to interrupt aspirin, other nonsteroidal anti-inflammatory drugs, or COX-2 inhibitors for a 5-day period. Have a second primary malignancy except carcinoma in situ of the cervix or nonmelanomatous skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. [1] Australia, New South Wales For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Bankstown, New South Wales, Australia; Recruiting For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Hornsby, New South Wales, Australia; Recruiting For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Kingswood Penrith, New South Wales, Australia; Recruiting For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Tamworth, New South Wales, Australia; Recruiting Australia, Queensland For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Douglas, Queensland, Australia; Recruiting For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Redcliffe, Queensland, Australia; Recruiting Australia, South Australia For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Bedford Park, South Australia, Australia; Recruiting For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Woodville, South Australia, Australia; Recruiting Australia, Victoria For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., NSW, QLD, South Australia, Victoria, Australia; Recruiting For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Geelong, Victoria, Australia; Recruiting For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Wodonga, Victoria, Australia; Recruiting Australia, Western Australia For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Perth, Western Australia, Australia; Recruiting