Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Colorectal Neoplasms

Neoplasm Metastasis

Gastrointestinal Neoplasms

Intestinal Neoplasms

Digestive System Neoplasms

Neoplastic Processes

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Bevacizumab

Leucovorin

Fluorouracil

Irinotecan

Capecitabine

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

Bevacizumab 5 mg/kg IV 90-30 min Day 1 CPT-11 180 mg/m2 (150 mg/m2) IV 90 min Day 1 l-LV (dl-LV) 200 mg/m2 (400 mg/m2) IV 120 min Day 1 5-FU - bolus 400 mg/m2 IV bolus Day 1 5-FU - infusional 2400 mg/m2 IV continuous (46 hours) Day 1 - 3

Bevacizumab 7.5 mg/kg IV 90-30 min Day 1 CPT-11 200 mg/m2 (150 mg/m2) IV 90 min Day 1 Capecitabine 800 mg/m2 p.o. twice daily 14 Days consecutively

5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle.

150-180 mg/m2 intravenously administered over 90 minutes on day 1 of a 2-week cycle.

CPT-11 (Irinotecan)

400 mg/m2 intravenous bolus on day 1 of a 2-week cycle.

5-FU Bolus

2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle.

5-FU Infusion

200 (dl-LV: 400) mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.

l-LV (dl-LV)

7.5mg/kg IV intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on Day 1 of a 3-week cycle.

bevacizumab

150-200 mg/m2 intravenously administered over 90 minutes on day 1 of a 3-week cycle.

1600mg/m2/day oral on day 1 (evening) to day 15 (morning)of a 3-week cycle.

Kei Muro, MD

Tae Won Kim, MD, PhD

Young Suk Park, MD, PhD

Ruihua Xu, MD, PhD

The primary purpose of this study is to determine the non-inferiority of overall survival XELIRI with or without Bevacizumab compared with FOLFIRI with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.

Primary endpoint: Overall survival (OS), Secondary endpoints: Progression-free survival (PFS), Time to treatment failure (TTF), Overall response rate (ORR),Disease Control Rate (DCR), Relative dose intensity, Safety, and Correlation between UGT1A1 genotype and Safety.

A Phase III Study of 2nd-line XELIRI ± Bevacizumab vs. FOLFIRI ± Bevacizumab in mCRC

A Multinational, Randomized, Phase III Study of XELIRI With/Without Bevacizumab Versus FOLFIRI With/Without Bevacizumab As Second-line Therapy in Patients With Metastatic Colorectal Cancer

Time from the date of enrollment to death from any cause.

Time from the date of enrollment to the earlier of the date of confirmed progression or death from any cause.

Time from the date of enrollment to the earlier of the date of confirmed progression, death from any cause, or discontinuation of protocol treatment.

Proportion of eligible patients with measurable lesions with a best overall response of CR or PR assessed by the attending physician.

Proportion of best overall response of CR, PR, or SD assessed by the attending physician.

will be calculated for each drug to evaluate treatment compliance in the all-treated population during the observation period.

The incidence of worst-grade adverse events (toxicities) on study as graded by NCI-CTCAE v 4.0 will be determined by treatment arm in all treated patients for the following events.

The incidence of worst-grade adverse events on study as graded by NCI-CTCAE v 4.0 will be determined by treatment arm and UGT1A1 genotype in all treated patients with a known UGT1A1 genotype profile

Spots Global Cancer Trial Database for axept

Every month we try and update this database with for axept cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for axept

Every month we try and update this database with for axept cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for axept cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.