Tailored Treatment in Metastatic Colorectal Cancer

• Status: Terminated
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the response rate of single agent chemotherapy in advanced colorectal cancer given as standard treatment versus tailored treatment in a randomised phase III trial.

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

Details

• Lead Sponsor: Vejle Hospital
• Treatments: Capecitabine; Fluorouracil; Irinotecan

Criteria

Inclusion Criteria:

• Metastatic colorectal cancer

• Histopathological verification of the primary tumor

• Measurable disease according to RESIST criteria

• Single agent chemotherapy indicated

• Performance status >=2

• Age >= 60 years

• Life expectancy > 3 months

• Adequate liver and kidney function as evaluated by bilirubin <= 3 times of normal upper limit, ALAT <= 3 times upper normal limit (<= 5 times upper normal limit in case of liver metastases), serum creatinine <= 1.5 times normal upper limit.

• ANC >=1.5 x 109/l and platelets >= 100 x 109/l

• Informed consent

Exclusion Criteria:

• Patients with CNS metastases

• Other malignant disease within the last 5 years except for non-melanoma skin cancer and carcinoma in situ of cervix uteri

• Previous chemotherapy for metastatic disease

• Adjuvant chemotherapy < 6 months before inclusion

• Patients with previous major toxic or allergic reaction to the protocol drugs