Metastatic adenocarcinoma of colon or rectum MedDRA version: 9.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer
Conditions
Sponsors
I.T.M.O. - ITALIAN TRIALS IN MEDICAL ONCOLOGY
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Italy
Outcome results
None listed