Comparing Efficacy and Safety of Stivant (AryoGen Bevacizumab) Versus Avastin in Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2018-07-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AryoGen Pharmed Co.
• Treatments: Bevacizumab; Fluorouracil; Irinotecan; Leucovorin

Criteria

Inclusion Criteria:

• Are male or female aged 18-75 years at the time of signing the informed consent form.

• Have been diagnosed as 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 Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

• Life expectancy of longer than 3 months ( clinical assessment)

• Adequate organ and marrow function as defined below:

• Absolute neutrophil count (ANC) greater than/equal to 1,500/mm3;

• Platelets greater than/equal to 100,000/ mm3;

• Hemoglobin greater than/equal to 9 gm/dl (may be transfused to maintain or exceed this level);

• Total bilirubin less than/equal to 1.5 within institutional upper limit of normal (IULN);

• Aspartate aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) less than/equal to 2.5 times IULN, or less than/equal to 5 times IULN if known liver metastases;

• 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). (Patients may have prophylactic use of low molecular weight heparin, however therapeutic use of heparin or low molecular weight heparin is not acceptable)

• 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;

• Clinically significant peripheral vascular disease;

• Uncontrolled diabetes; Serious active or uncontrolled infection

• Inability to comply with study and/or follow-up procedures