PATIENTS WITH METASTATIC COLORECTAL CANCER MedDRA version: 9.1 Level: LLT Classification code 10062099 Term: Rectal neoplasm
Conditions
Interventions
Trade Name: IRINOTECAN MAYNE
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Irinotecan
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
AZIENDA OSPEDALIERA SENESE
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Metastatic disease pretreated with chemotherapy Resectable metastatic disease Not availability of metastatic tumor tissue Congestive heart failure Cronic diarrhea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed