Comparing Irinotecan and 5 FU/FA To 5-FU/FA After Resection Of Liver Metastases For Colorectal Cancer

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To see if Disease Free Survival (DFS) is improved when complete surgical resection of liver metastases (R0) is followed by chemotherapy with CPT-11 and 5-FU/FA as FOLFIRI regimen, compared to 5-FU/FA alone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Fluorouracil; Folic Acid; Irinotecan; Leucovorin; Levoleucovorin

Criteria

Inclusion Criteria:

• Histologically proven adenocarcinoma of the colon or rectum with complete resection of primary tumour.

• Complete surgical resection (R0) of the liver metastasis(es) within a minimum of 3 weeks, and a maximum of 8 weeks prior to the first study treatment infusion.

• Exclusively hepatic metastasis (es) : absence of bone, lung and brain metastases.

Exclusion Criteria:

• Prior hepatic radiation or resection.

• Prior radiofrequency ablation or cryoablation Incomplete surgical resection of liver metastasis (es).

• Prior chemotherapy for metastatic disease.