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

Hoosier Cancer Research Network

Novartis Pharmaceuticals

Pfizer

Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.

Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.

CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.

Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.

Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.

Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.

Bevacizumab / Capecitabine

Bevacizumab / Docetaxel

Bevacizumab / CPT-11

Bevacizumab / Paclitaxel

Bevacizumab /Vinorelbine Tartrate

Bevacizumab / Gemcitabine

Total

Gender

Region of Enrollment

Primary endpoint has not been analysed secondary to slow and low accrual numbers.

Safety and Tolerability Will be Assessed According to Standard (CTCAE Version 3.0) Toxicity Reporting Criteria.

Due to slow accrual study was prematurely closed and endpoint not analysed

Assess the Activity of Avastin When Added to Single Agent Chemotherapy, as Measured by Radiographic Response Rate,Progression Free Survival, and Overall Survival.

Determining the Safety and Tolerability of Adding Avastin to Single Agent Chemotherapy to Treat Patients With Brain Metastasis Originating From Breast Cancer

To Assess the Quality of Life During Treatment With This Therapeutic Approach

Bevacizumab / Irinotecan (Camptosar®, CPT-11)

Overall Study

Kimberly Blackwell, MD

Avastin (Bevacizumab)/ Capecitabine (Xeloda)

Avastin (Bevacizumab) / Camptosar (CPT 11/ Irinotecan)

Avastin (Bevacizumab)/Gemzar(Gemcitabine,Difluorodeoxycytidine

Avastin (Bevacizumab)/Navelbine (Vinorelbine Tartrate)

Breast Cancer

Bevacizumab(Avastin) 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle. until progression or unacceptable toxicity develops

Bevacizumab

Docetaxel 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle. until progression or unacceptable toxicity develops

Docetaxel

CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.until progression or unacceptable toxicity develops

CPT-11

Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.until progression or unacceptable toxicity develops

Paclitaxel

Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle. until progression or unacceptable toxicity develops

Vinorelbine Tartrate

Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.until progression or unacceptable toxicity develops

Gemcitabine

Palm Beach Cancer Center Institute

Presbyterian Health Care

Duke University Medical Center

Virginia Oncology Associates

A Phase II Safety and Tolerability Study of Bevacizumab When Added to Single-agent Chemotherapy to Treat Patient With Breast Cancer Metastatic to Brain

A Phase II Safety and Tolerability Study of Avastin When Added to Single-agent Chemotherapy to Treat Patient With Breast Cancer Metastatic to Brain

Duke University

Genentech, Inc.

Irinotecan 200 mg/m2 IV, day 1
Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles
For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid
EUS
Neoadjuvant Chemotherapy
Preoperative Radiation
Surgery
Adjuvant Chemotherapy (at discretion of treating physician)

Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles
*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Irinotecan: Irinotecan 200 mg/m2 IV, day 1
EUS: biopsy per EUS
Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles
Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4
Surgery: Surgery within 8 weeks following chemoradiotherapy
Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion

Single Group Assignment

Sex: Female, Male

Race (NIH/OMB)

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) from 0-5 that describes a patient's level of functioning where 0=Fully active, able to carry on all pre-disease performance without restriction and 5=Dead:

Eastern Cooperative Oncology Group (ECOG) performance status

Tumor Node Metastasis (TNM) Staging. This system classifies tumors by size and extent of the primary tumor (T), involvement of regional lymph nodes (N), and the presence or absence of distant metastases (M) T0=No evidence of primary tumor, Tis=Carcinoma in situ, and T1, T2, T3, T4=Increasing size and/or local extension of the primary tumor, TX=Not assessed N0=No Regional lymph node metastases, N1, N2, N3=Increasing number or extent of regional lymph node involvement, NX=not assessed M0=No distant metastases, M1=Distant metastases present

Tumor Node Metastatis (TNM) Stage

· To determine the pathological response rate of preoperative chemotherapy with capecitabine and irinotecan followed by combined modality chemoradiation with capecitabine in patients with locally advanced rectal cancer.
Pathological response was defined in the protocol as the proportion of complete (pCR) and non-complete pathological response (pNCR) among all evaluable patients.

Pathological Complete Response (pCR) Rate

To determine the rates of local and distant disease recurrence after treatment.

Local and Distant Disease Recurrence Rates

To determine the rate of clinical response following induction chemotherapy with capecitabine and irinotecan, and also the overall clinical response after the completion of chemoradiation with capecitabine.

Rate of Clinical Response

The three year rate of Disease-Free Survival

Disease-Free Survival

Principal Investigator

Rectal Cancer

Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles
*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid

Capecitabine

Irinotecan 200 mg/m2 IV, day 1
Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles

Neoadjuvant Chemotherapy

Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4

Preoperative Radiation

Surgery within 8 weeks following chemoradiotherapy

Surgery

Adjuvant chemotherapy at investigator's discretion

Adjuvant Chemotherapy

Elkhart Clinic

Fort Wayne Oncology & Hematology, Inc

Center for Cancer Care at Goshen Health System

Indiana University Cancer Center

Quality Cancer Center (MCGOP)

Medical Consultants, P.C.

AP&S Clinic

Capecitabine + Irinotecan Followed by Combined Modality Capecitabine and Radiation in Locally Advanced Rectal Cancer

A Phase II Trial of Preoperative Capecitabine Plus Irinotecan Followed by Combined Modality Capecitabine and Radiation for Locally Advanced Rectal Cancer: Hoosier Oncology Group GI03-53

irinotecan/infarto

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

A Phase II Safety and Tolerability Study of Bevacizumab When Added to Single-agent Chemotherapy to Treat Patient With Breast Cancer Metastatic to Brain

Capecitabine + Irinotecan Followed by Combined Modality Capecitabine and Radiation in Locally Advanced Rectal Cancer

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