Bevacizumab+FOLFIRI-3 (irinotecan, leucovorin, and 5-FU). Bevacizumab (AryoGen) 5 mg/kg will be administered every 2 weeks.

Bevacizumab+FOLFIRI-3 (irinotecan, leucovorin, and 5-FU). Bevacizumab (Avastin®) 5 mg/kg will be administered every 2 weeks.

Metastatic Colorectal Cancer

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.

Bevacizumab + FOLFIRI-3

This protocol is registered according to program in Iran Registry of Clinical Trial (IRCT) with IRCT2015072517994N2 code

Shafa Hospital

Shahid Beheshti Hospital

Saba Clinic

Sheikh Mofid

Payandeh Clinic

Shazad Clinic

Imam Reza Hospital

Qaem Hospital

Rasool Hospital

Razi Hospital

Namazi Hospital

Firoozgar Hospital

Imam Khomeini Hospital

Imam Reza Hospital (501 Artesh)

Masih Daneshvari Hospital

Masoud Internal Clinic

Safa najafi clinic

Shariati Hospital

Sina Hospital

Taleqani Hospital

Mortazavizadeh Clinic

Seyedshohada Hospital

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

A Phase III, Randomized, Two-armed, Triple Blinded, Parallel, Active Controlled Non-Inferiority Clinical Trial of Stivant (AryoGen Trastuzumab) Efficacy and Safety in Comparison to Avastin in Metastatic Colorectal Cancer

PFS is defined as the time from the date of randomization to the first date of documentation progression (per investigator assessment) or death as a result of any cause.

Overall survival OS is defines as the time from date of randomization to date of death due to any cause

Tumor response was defined as partial and complete responses, according to the RECIST criteria

Time of treatment failures define as the time from the date of randomization to the date of each of the following,
The treatment modalities did not destroy or modify the cancer cell.
The tumor either became larger (disease progression) or stayed the same size after treatment,
Death from any cause
Discontinuation of treatment

Safety wills assess on the basis of reports of adverse events, laboratory-test results, and vital sign measurements. Adverse events were categorized According to the Common Toxicity Criteria of the National Cancer Institute, version 4.0, in which a grade of 1 indicates mild adverse events, a grade of 2 moderate adverse events, a grade of 3 serious adverse events, and a grade of 4 life-threatening adverse events

antidrug antibody and neutralizing antibody assessment

AryoGen Pharmed Co.

Colorectal Cancer

Irinotecan

Cetuximab

Patients on Arm A will crossover and receive RAD001 at disease progression

RAD001

Northwestern University Feinberg School of Medicine

Medical & Surgical Specialists, LLC

Cancer Care Center of Southern Indiana

Oncology Hematology Associates of SW Indiana

IN Onc/Hem Associates

Indiana University Simon Cancer Center

St. Vincent Hospital & Health Centers

Community Regional Cancer Center

Arnett Cancer Care

Horizon Oncology Center

Monroe Medical Associates

Center for Cancer Care, Inc., P.C.

Northern Indiana Cancer Research Consortium

Siteman Cancer Center

Phase I/Randomized Phase II Study of Second Line Therapy With Irinotecan + Cetuximab +/- RAD001 for Colorectal Cancer

Phase I / Randomized Phase II Study of Second Line Therapy With Irinotecan and Cetuximab With or Without RAD001, an Oral mTOR Inhibitor for Patients With Metastatic Colorectal Cancer: Hoosier Oncology Group GI05-102

irinotecan/ictus

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

Phase I/Randomized Phase II Study of Second Line Therapy With Irinotecan + Cetuximab +/- RAD001 for Colorectal Cancer

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