Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

July 9, 2010
July 14, 2010
July 2007
Not Provided
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.
Same as current
Complete list of historical versions of study NCT01163396 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
First-line FOLFOXIRI In Combination With Bevacizumab For Metastatic Colorectal Cancer
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

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Colorectal Adenocarcinoma
  • Drug: Bevacizumab
  • Drug: Irinotecan
  • Drug: Oxaliplatin
  • Drug: 5-fluorouracil/leucovorin
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
Interventions:
  • Drug: Bevacizumab
  • Drug: Irinotecan
  • Drug: Oxaliplatin
  • Drug: 5-fluorouracil/leucovorin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
Not Provided
Not Provided

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01163396
ASL606LIOM01
Yes
Gruppo Oncologico del Nord-Ovest
Gruppo Oncologico del Nord-Ovest
  • Fondazione Associazione Ricerca e Cura in Oncologia (ARCO)
  • Roche Pharma AG
Principal Investigator: Alfredo Falcone, MD University of Pisa
Gruppo Oncologico del Nord-Ovest
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP