Treatment with Oxaliplatin and Irinotecan in colorectal metastatic tumors with high expression of thymidilate synthase (TS). - IRINOX

• Conditions: PATIENTS WITH METASTATIC COLORECTAL CANCER; MedDRA version: 9.1Level: LLTClassification code 10062099Term: Rectal neoplasm

• Registration Number: EUCTR2008-000217-30-IT
• Lead Sponsor: AZIENDA OSPEDALIERA SENESE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-04
• Last Update Posted: 11 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients with metastatic colorectal adenocarcinoma that has not received a previous chemotherapy for metastatic disease.

Availability of tumor tissue from metastatic sites for immunoistochemical determination of Thymidilate synthase (TS).

Patients who had received adjuvant chemotherapy may be enrolled if they were disease free tratment for at least 6 months after the stop of adjuvant therapy.

ECOG Performance status of 0-2.

Measurable or evaluable metastatic disease.

Life expectancy of at least 3 months.

Adequate haematologic parameters (neutrophils  1.5 x 109 /L, and platelets 100x 109 /L), serum creatinine and total bilirubin  1.25 times the upper limit of normal range; transaminases < 3 times the upper limit pf normal range.

Absence of a second tumor with the exception of non-melanoma tumor or in situ carcinoma of the cervix.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Metastatic disease pretreated with chemotherapy
Resectable metastatic disease
Not availability of metastatic tumor tissue
Congestive heart failure
Cronic diarrhea

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The principle end-point of the study is to evaluate the therapeutic response achieved in patients with metastatic colorectal cancer with high espression of the enzyme thymidilate synthase (TS), treated with a combiation regimen not including fluoropirimidines.;Secondary Objective: Secondary end-points are progression-free survival, survival, and the correlation between therapeutic response and intratumoral expression of TS.;Primary end point(s): The principle end-point of the study is to evaluate the therapeutic response achieved in patients with metastatic colorectal cancer with high espression of the enzyme thymidilate synthase (TS), treated with a combiation regimen not including fluoropirimidines.