A Study of the Combination of Pemetrexed and Irinotecan Every Two Weeks in Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

A non-randomized phase II study to determine the efficacy and safety of the combination of Pemetrexed and Irinotecan every two weeks in metastatic colorectal cancer patients.

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Camptothecin; Irinotecan; Pemetrexed

Criteria

Inclusion Criteria:

• Diagnosis of metastatic colorectal adenocarcinoma that is not amenable to curative therapy.

• Patient must have at least one unidimensionally measurable lesion.

• Prior radiation therapy to less than 25% of bone marrow. Radiation must be completed at least 4 weeks prior to study enrollment.

• Performance status 0 to 2

• Patient must have received 1 prior course of chemotherapy (Folfox regimen) for metastatic disease

Exclusion Criteria:

• Treatment with any drug within the last 30 days that has not received regulatory approval.

• Serious systemic disorder (cardiac or pulmonary disease, active infection)

• Documented brain metastases not amenable to surgery or unstable after radiation

• Inability or unwillingness to take folic acid or Vitamin B12 supplementation.

• Presence of fluid retention that can not be controlled by drainage.