Text Size

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

This study has been completed.
Sponsor:
Collaborators:
Fondazione Associazione Ricerca e Cura in Oncologia (ARCO)
Roche Pharma AG
Information provided by:
Gruppo Oncologico del Nord-Ovest
ClinicalTrials.gov Identifier:
NCT01163396
First received: July 9, 2010
Last updated: July 14, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Metastatic Colorectal Adenocarcinoma
 Drug: Bevacizumab
Drug: Irinotecan
Drug: Oxaliplatin
Drug: 5-fluorouracil/leucovorin
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label, Multicenter, Phase II Study Of First-line Biweekly Irinotecan, Oxaliplatin And Infusional 5-FU/LV (FOLFOXIRI) In Combination With Bevacizumab In Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gruppo Oncologico del Nord-Ovest:

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: PFS rate at 10 months from study entry ] [ Designated as safety issue: No ]
    PFS was calculated from the day of treatment start to the first observation of disease progression or death from any cause.


Secondary Outcome Measures:
  • Response rate (RR) [ Time Frame: 2007-2010 ] [ Designated as safety issue: No ]
    Response evaluation was performed every 8 weeks from the day of treatment start until disease progression for each enrolled patient for the full lenght of the study. Response evaluation was performed according to RECIST criteria. Responses were subsequently confirmed by a central review.

  • Overall survival (OS) [ Time Frame: 2007-2010 ] [ Designated as safety issue: No ]
    OS was calculated from the day of treatment start until death from any cause for each enrolled patient for the full lenght of the study, censoring patients who had not died at the last date known to be alive.

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 2007-2010 ] [ Designated as safety issue: Yes ]
    During the full lenght of first-line treatment, number of enrolled patients reporting adverse events was recorded. Adverse events were evaluated according to National Cancer Institute Common Toxicity Criteria (version 3.0).

  • Evaluation of potential surrogate markers predictive of bevacizumab activity [ Time Frame: 2007-2010 ] [ Designated as safety issue: No ]
    During first-line therapy and at disease progression.


Enrollment: 57
Study Start Date: July 2007
Arms Assigned Interventions
Experimental: FOLFOXIRI plus bevacizumab
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
 Drug: Bevacizumab Drug: Irinotecan Drug: Oxaliplatin Drug: 5-fluorouracil/leucovorin

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163396

Sponsors and Collaborators
Gruppo Oncologico del Nord-Ovest
Fondazione Associazione Ricerca e Cura in Oncologia (ARCO)
Roche Pharma AG
Investigators
Principal Investigator: Alfredo Falcone, MD University of Pisa
  More Information

No publications provided

Responsible Party: Gruppo Oncologico del Nord-Ovest
ClinicalTrials.gov Identifier: NCT01163396     History of Changes
Other Study ID Numbers: ASL606LIOM01
Study First Received: July 9, 2010
Last Updated: July 14, 2010
Health Authority: Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Colorectal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
 Intestinal Diseases
Rectal Diseases
Fluorouracil
Oxaliplatin
Irinotecan
Bevacizumab
Leucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 23, 2013