Status:
COMPLETED
First-line FOLFOXIRI In Combination With Bevacizumab For Metastatic Colorectal Cancer
Lead Sponsor:
Gruppo Oncologico del Nord-Ovest
Conditions:
Colorectal Cancer Metastatic
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a single-arm, open-label, multicentre phase II study evaluating the safety and efficacy of the combination of the G.O.N.O. FOLFOXIRI regimen with bevacizumab as first-line treatment of metasta...
Eligibility Criteria
Inclusion
- Histologically confirmed colorectal adenocarcinoma
- Unresectable and measurable metastatic disease (RECIST criteria)
- Male or female, aged \> 18 years and ≤ 75 years
- ECOG Performance Status (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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01163396
Start Date
July 1 2007
End Date
April 1 2010
Last Update
March 11 2015
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