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

• Conditions: untreated patients with advanced colorectal cancer.; MedDRA version: 9.1Level: LLTClassification code 10010035Term: Colorectal cancer stage IV

• Registration Number: EUCTR2006-002887-25-IT
• Lead Sponsor: GOIM GRUPPO ONCOLOGICO MERIDIONALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

Serum creatinine <= 1.5 x ULN

Effective contraception in female patients at risk of conception/absence of pregnancy or breastfeeding

Signed written informed consent.
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

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

Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix (patients with a previous malignancy but with no evidence of disease for > 5 years will be allowed to enter the trial)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Objectively confirmed response rate <br><br>Time-to- progression;Secondary Objective: Safety of combination<br><br>Median response duration<br><br>Overall survival time<br><br>Post-treatment resectability of lung/liver metastases;Primary end point(s): Objectively confirmed response rate <br><br>Time-to- progression