EUCTR2006-002887-25-IT
Active, not recruiting
Not Applicable
Bevacizumab+folfiri in untreated patients with advanced colorectal cancer. A phase II multicenter study of the Gruppo Oncologico dell'Italia Meridionale. (GOIM). - Bevacizumab+folfiri in untreated patients with advanced colorectal cance
GOIM GRUPPO ONCOLOGICO MERIDIONALE0 sitesJune 26, 2007
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- untreated patients with advanced colorectal cancer.
- Sponsor
- GOIM GRUPPO ONCOLOGICO MERIDIONALE
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Locally advanced or metastatic non\-resectable colorectal cancer
- •Histologically confirmed adenocarcinoma
- •Presence of at least one measurable lesion
- •Age \>\= 18 years and \< 75 years
- •Karnofsky performance status of \> 70 at study entry
- •Life expectancy of \> 3 months
- •Laboratory data:
- •Neutrophils \>\= 1\.5 x 109/L, platelets \>\= 100 x 109/L, hemoglobin \>\= 9 g/dl
- •ALAT and ASAT \<\= 2\.5 x ULN (\< 5 x ULN if liver metastases are present)
- •Total Bilirubin \<\= 1\.5 x ULN
Exclusion Criteria
- •Brain metastasis
- •Previous chemotherapy for locally advanced or metastatic colorectal (adjuvant therapy without irinotecan is allowed if recurrence is documented \> 6 months after the end of adjuvant treatment)
- •Radiotherapy within 4 weeks prior to study entry
- •Clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months
- •Acute or subacute intestinal occlusion or history of the inflammatory bowel disease
- •Patients with peripheral neuropathy (NCI CTC \>1\)
- •Known drug abuse/alcohol
- •Legal incapacity or limited legal capacity
- •Medical or psychological condition which, in the opinion of the investigator, would not enable the patient to complete the study or knowingly sign the Informed Consent
- •Women who are pregnant or breastfeeding
Outcomes
Primary Outcomes
Not specified
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