Comparing Efficacy and Safety of Stivant (AryoGen Bevacizumab) Versus Avastin in Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase III, randomized, two arms, double-blind (patient and assessor blinded),
      parallel active non inferiority controlled clinical trial with a 2:1 allocation. This trial
      was conducted to evaluate the efficacy and safety of bevacizumab (produced by AryoGen
      Pharmed) plus FOLFIRI-3 compared with bevacizumab (Avastin®) plus FOLFIRI-3 in patients with
      metastatic colorectal cancer (mCRC). Patients who met the following criteria could be
      recruited to receive the mentioned intervention randomly. Inclusion criteria: male or female
      aged 18-75 years, mCRC verified histologically, Having one or more bi-dimensionally
      measurable lesions as defined by Response Evaluation Criteria In Solid Tumors (RECIST)
      criteria, Was not felt to be amenable to curative resection, With an (ECOG) performance
      status of ≤ 1, Life expectancy of longer than 3 months, Adequate organ and marrow function,
      May have received adjuvant therapy for primary colorectal cancer provided that at least 6
      months have elapsed from the time the adjuvant therapy was concluded and recurrent disease
      was documented, Patients with history of hypertension must be well-controlled (blood pressure
      less than/equal to 150/100), on a stable regimen of anti-hypertensive therapy.
    

Detailed description: 
      This is a Phase III, randomized, two arms, double-blind (patient and assessor blinded),
      parallel active non inferiority controlled clinical trial with a 2:1 allocation. This trial
      was conducted to evaluate the efficacy and safety of bevacizumab (produced by AryoGen) plus
      FOLFIRI-3 compared with bevacizumab (Avastin®) plus FOLFIRI-3 in patients with metastatic
      colorectal cancer (mCRC). Patients who met the following criteria could be recruited to
      receive the mentioned intervention randomly. Inclusion criteria: male or female aged 18-75
      years, mCRC verified histologically, Having one or more bi-dimensionally measurable lesions
      as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria, Was not felt to
      be amenable to curative resection, With an (ECOG) performance status of ≤ 1, Life expectancy
      of longer than 3 months, Adequate organ and marrow function, May have received adjuvant
      therapy for primary colorectal cancer provided that at least 6 months have elapsed from the
      time the adjuvant therapy was concluded and recurrent disease was documented, Patients with
      history of hypertension must be well-controlled (blood pressure less than/equal to 150/100),
      on a stable regimen of anti-hypertensive therapy. Exclusion criteria: Prior targeted therapy
      for mCRC, Radiotherapy or surgery for mCRC less than 4 weeks before random assignment,
      Undergone major surgical procedures or open biopsy within 28 days before the initiation of
      study treatment, Experienced significant traumatic injury, within 28 days before study entry,
      Currently using or had recently used therapeutic anticoagulants, thrombolytic therapy,
      chronic, daily treatment with aspirin (higher than 325 mg/daily), Proteinuria exceeding
      500mg/24 h, History or presence of central nervous system metastases, Female patients who are
      pregnant or lactating, Patients with a history of allergic reactions attributed to compounds
      of similar chemical or biologic composition to bevacizumab, irinotecan, 5-FU, or leucovorin,
      Serious non-healing wound, ulcer, or active bone fracture, Myocardial infarction within 6
      months before of study enrollment, History of stroke within 6 months before of study
      enrollment, Unstable symptomatic arrhythmia requiring medication, Clinically significant
      peripheral vascular disease, Uncontrolled diabetes; Serious active or uncontrolled infection,
      Inability to comply with study and/or follow-up procedures. The primary endpoint is
      progression-free survival and overall survival, Objective Response rate, time of treatment
      failures, adverse events and immunogenicity will be assessed as secondary outcomes.
    

Intervention name(s): Bevacizumab + FOLFIRI-3
Intervention type(s): Drug
Intervention description(s): Bevacizumab 5 mg/kg will be administered at day 1 every 2 weeks. Initially, it will be administered as a 90-min infusion. If the first infusion is well tolerated, the second will be delivered as a 60-min infusion, and if the 60-min infusion is well tolerated, all subsequent infusions will be given over 30 minutes. FOLFIRI-3 regimen consists of irinotecan 100 mg/m2 over 1 hour at day 1, leucovorin 400 mg/m2 at day 1 followed by a 46 hour 5-FU continuous infusion (2000 mg/m2) and irinotecan 100 mg/m2 over 1 hour on day 3 will administer. Induction treatment was administrated every 2 weeks until disease progression, unacceptable toxicities, surgical intervention, or withdrawal of consent.
Other intervention name(s): FOLFIRI-3 = irinotecan + calcium folinate + 5-fluorouracil
Intervention MeSH terms: Leucovorin; Bevacizumab; Fluorouracil; Irinotecan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment