EUCTR2008-000217-30-ITActive, not recruitingNot Applicable
Treatment with Oxaliplatin and Irinotecan in colorectal metastatic tumors with high expression of thymidilate synthase (TS). - IRINOX
AZIENDA OSPEDALIERA SENESE0 sitesStarted: February 4, 2008Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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