ClinicalTrials.Veeva

Menu

First-line FOLFOXIRI In Combination With Bevacizumab For Metastatic Colorectal Cancer (FOIB)

G

Gruppo Oncologico del Nord-Ovest

Status and phase

Completed
Phase 2

Conditions

Colorectal Cancer Metastatic

Treatments

Drug: Irinotecan
Drug: Bevacizumab
Drug: Oxaliplatin
Drug: 5-fluorouracil/leucovorin

Study type

Interventional

Funder types

Other

Identifiers

NCT01163396
ASL606LIOM01

Details and patient eligibility

About

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 metastatic colorectal cancer.

Enrollment

57 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

57 participants in 1 patient group

FOLFOXIRI plus bevacizumab
Experimental group
Description:
BEVACIZUMAB 5 mg/Kg i.v. followed by IRINOTECAN 165 mg/sqm i.v. over 1 hr followed by OXALIPLATIN 85 mg/sqm i.v. over 2 hr concomitantly with l-LV 200 mg/sqm over 2 hrs followed by 5FU 3.200 mg/sqm c.i. over 48 hrs starting on day 1. Cycles repeated every 2 weeks
Treatment:
Drug: Irinotecan
Drug: Bevacizumab
Drug: Oxaliplatin
Drug: 5-fluorouracil/leucovorin

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems