Official Title: “Multi-Centre Phase III Open Label Randomized Trial Comparing CPT-11 In Combination With A 5-FU/FA Infusional Regimen To The Same 5-FU/FA Infusional Regimen Alone, As Adjuvant Treatment After Resection Of Liver Metastases For Colorectal Cancer.”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Study Primary Completion Date: February 2008

Intervention(s) in this Clinical Trial

• Drug: Irinotecan + 5 FU + folinic acid
  • irinotecan 180 mg/m2 folinic acid 400 mg/m2 (DL) followed by 5 FU bolus 400 mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks
• Drug: Folinic Acid + 5 FU
  • folinic acid 400 mg/m2(DL) followed by bolus 5 FU 400mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Disease Free Survival (DFS)
  • Time Frame: last tumor assessment date or cut-off date, whichever is earlier.
    Safety Issue?: No

Secondary Measures

• Overall Survival Rates
  • Time Frame: Median follow-up time (42 months)
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00143403

Study ID Number: CPT-GMA-301

ClinicalTrials.gov Identifier: NCT00143403

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

To obtain contact information for a study center near you, click here.