Tailored Treatment in Metastatic Colorectal Cancer

NCT ID: NCT00396487

Last Updated: 2015-06-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-02-29

Brief 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.

Detailed Description

The TS and MTHFR polymorphism has been investigated in a new study based on analysis of normal tissue. The results indicated that protein with a 3/3 TS polymorphism or a MTHFR T polymorphism had a significantly higher response rate and a longer time to progression than the other groups when treated with bolus 5-FU.

Capecitabine is metabolised to 5-FU through a number of enzymatic steps. It is the first rationally designed drug that is based upon the high concentration of thymidine phosphorylase (TP) in many human tumors compared to normal tissue. TP is the last step in the conversion of capecitabine to 5-FU and seems to be the limiting factor for the activation. Capecitabine may to some extent mimic continues 5-FU infusion as opposed to bolus 5-FU. A number of small investigations have indicated that patients with 2R/2R TS polymorphism have a higher response rate than heterozygous patients.

The TS and MTHFR polymorphism analysis can easily be performed on sputum, which means an easy collection and sending of the samples.

At present single agent chemotherapy is based on three drugs (5-FU, capecitabine, and Irinotecan) with almost the same overall activity. It seems rational to investigate if improvement can be obtained by tailoring the treatment according to gene polymorphism.

Conditions

Metastatic Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Capecitabine, Irinotecan, 5-Fluorouracil+Calciumfolinat

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vejle Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders Jakobsen, Prof, MDSc

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology, Vejle Hospital, 7100 Vejle, DK-Denmark

Locations

Aalborg Hospital

Aalborg, , Denmark

Aarhus University Hospital

Aarhus, , Denmark

Rigshospitalet

Copenhagen, , Denmark

Sydvestjysk Hospital Esbjerg

Esbjerg, , Denmark

Herlev Hospital

Herlev, , Denmark

Herning Central Hospital

Herning, , Denmark

Næstved Hospital

Næstved, , Denmark

Odense University Hospital

Odense, , Denmark

Roskilde Hospital

Roskilde, , Denmark

Viborg Hospital

Viborg, , Denmark

Countries

Denmark

Other Identifiers

TT-2006-002957-56

Identifier Type: -

Identifier Source: org_study_id