First Line UFT, OXALIPLATIN and ERBITUX combination (TEGAFOX-E) in Elderly (= 70 years) metastatic colorectal patients: a Phase II ITMO study. - TEGAFOX-E

• Conditions: Metastatic adenocarcinoma of colon or rectum; MedDRA version: 9.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancer

• Registration Number: EUCTR2008-001355-21-IT
• Lead Sponsor: I.T.M.O. - ITALIAN TRIALS IN MEDICAL ONCOLOGY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

Elderly patients (≥ 70 years) with histologically documented metastatic adenocarcinoma of colon or rectum and the presence of at least one inidimensionally measurable lesion. Immunohistochemistry expression of EGFR on the primary tumor cells is not mandatory for patients` enrollement. Adjuvant chemotherapy, if administered, completed at least 6 months before study enrollment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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

Serous illness or medical condition: congestive hearth failure or angina pectoris even medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled high risk hypertension or arrythmya. Previous treatment for metastatic disease with chemotherapy and/or Erbitux. Presence of metastatic CNS involvement.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the respons rate ORR (CR+PR);Secondary Objective: To evaluate the time to progression (TTP) To evaluate the duration of response (DOR) To evaluate the safety profile To evaluate the overall survival time To evaluate the quality of life according to EORTC QLC30;Primary end point(s): To assess the respons rate ORR (CR+PR)