OPEN-LABEL, MULTICENTER, PHASE II STUDY OF FIRST- LINE BI-WEEKLY IRINOTECAN, OXALIPLATIN AND INFUSIONAL 5FU/LV (FOLFOXIRI) IN COMBINATION WITH BEVACIZUMAB IN PATIENTS WITH METASTATIC COLORECTAL CANCER. - FOIB

• Conditions: IN PATIENTS WITH METASTATIC COLORECTAL CANCER.; MedDRA version: 9.1Level: HLTClassification code 10009945Term: Colonic neoplasms malignant

• Registration Number: EUCTR2006-001007-11-IT
• Lead Sponsor: G.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-10
• Last Update Posted: 28 August 2012

Recruitment & Eligibility

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

Inclusion Criteria

Histologically confirmed colorectal adenocarcinoma;

Unresectable and measurable metastatic disease (RECIST criteria);

Male or female, aged > 18 years and <= 75 years;

ECOG PS < 2 if aged < 71 years;

ECOG PS = 0 if aged 71-75 years;

Life expectancy of more than 3 months;

Adequate haematological function: ANC >= 1.5 x 109/L; platelets >= 100 x 109/L, Hb >= 9 g/dL;

INR <= 1.5 and aPTT <= 1.5 x ULN within 7 days prior to starting study treatment;

Adequate liver function: serum bilirubin <= 1.5 x ULN; alkaline phosphatase and transaminases <= 2.5 x ULN (in case of liver metastases < 5 x ULN);

Serum Creatinine <= 1.5 x ULN;

Urine dipstick for proteinuria < 2+. If urine dipstick is >= 2+, 24- hour urine must demonstrate <= 1 g of protein in 24 hours;

Previous adjuvant chemotherapy is allowed if more than 12 months have elapsed between the end of adjuvant therapy and first relapse;

At least 6 weeks from prior radiotherapy and 4 weeks from surgery.
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

Prior palliative chemotherapy;

Prior treatment with bevacizumab;

Bowel obstruction (or subobstruction). History of inflammatory enteropathy or extensive intestinal resection (> hemicolectomy or extensive small intestine resection with chronic diarrhea);

Symptomatic peripheral neuropathy > 2 grade NCIC-CTG criteria;

Presence or history of CNS metastasis;

Active uncontrolled infections; active disseminated intravascular coagulation;

Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment, or anticipation of the need for major surgery during the course of the study. Central Venous Access Device (CVAD) for chemotherapy administration inserted within 2 days prior to study treatment start;

Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin cancer or in situ carcinoma of the cervix;

Clinically significant cardiovascular disease, for example cerebrovascular accidents (CVA) (<= 6 months before treatment start), myocardial infarction (<= 6 months before treatment start), unstable angina, NYHA >= grade 2 chronic heart failure (CHF), uncontrolled arrhythmia;

Uncontrolled hypertension;

24-hour urine protein > 1 g if dipstick > 2+;

History of thromboembolic or hemorrhagic events within 6 months prior to treatment;

Evidence of bleeding diathesis or coagulopathy;

Serious, non healing wound/ulcer or serious bone fracture;

No therapeutic anticoagulation or antiplatelet agents or NSAID with anti-platelet activity (aspirin <= 325 mg/day allowed);

Pregnancy or lactation;

Fertile women (< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception.

Study & Design

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