Spots Global Cancer Trial Database for Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone
Official Title: Phase II Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone Administered Intravenously to Patients With Colorectal Adenocarcinoma Previously Untreated for Metastatic Disease
Study ID: NCT00890305
Conditions
Study Description
Brief Summary: This clinical trial will be performed in previously untreated patients with metastatic colorectal cancer. The study will evaluate the safety, tolerability and efficacy of the study drug, CT-011, in combination with FOLFOX chemotherapy (FOLFOX4 or mFOLFOX6) compared with treatment by FOLFOX alone.
Detailed Description: The proposed clinical trial will be a multi-center, randomized, open label, active control study in previously untreated patients with metastatic colorectal cancer aimed to evaluate the safety, tolerability and efficacy of the monoclonal antibody, CT-011, administered at 3mg/kg in combination with FOLFOX chemotherapy (FOLFOX4 or mFOLFOX6) compared with treatment by FOLFOX alone. Approximately 168 patients are planned to be enrolled to this study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Cancer Center of Huntsville, PC, Huntsville, Alabama, United States
University of South Florida, Tampa, Florida, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Signal Point Clinical Research Center, Middletown, Ohio, United States
Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas, United States
MHAT "Dr. Tota Venkova", Gabrovo, , Bulgaria
InterDistrict Dispensary in Oncology Diseases with Stationary-Ruse, EOOD, Ruse, , Bulgaria
InterDistrict Dispensary in Oncology Diseases with Stationary, Shumen, , Bulgaria
Multiprofile Hospital for Active Treatment "Tsaritza Joanna", Sofia, , Bulgaria
Specialized Hospital for Active Treatment for Oncology, Sofia, , Bulgaria
InterDistrict Dispensary of Oncology Diseases with Stationary, Varna, , Bulgaria
Multiprofile Hospital for Active Treatment "Sv. Marina", EAD,, Varna, , Bulgaria
Regional Cancer Centre, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna, Bihar, India
Cancer Clinic, Nagpur, Maharashtra, India
Curie Manavata Cancer Centre, Opp., Nashik, Maharashtra, India
Ruby Hall Clinic, Pune, Maharashtra, India
Deenanath Mangeshkar Hospital and Research Centre, Pune, Maharashtra, India
G. Kuppuswamy Naidu Memorial Hospital, Pappanaickenpalayam, Coimbatore, Tamilnadu, India
Hospital Almanzor Aguinaga Asenjo - Chiclayo, Chiclayo, , Peru
Clinica Ricardo Palma, Lima, , Peru
Hospital Regional nivel III Cayetano Heredia Essalud Piura, Piura, , Peru
Ponce School of Medicine/CAIMED Center, Ponce, , Puerto Rico
Fundacion de Investigacion de Diego, Santurce, , Puerto Rico
"Prof. Dr. Ion Chiricuţă" Institute of Oncology, Cluj-Napoca, , Romania
Clinical Emergency Hospital - Oncology Department, Constanta, , Romania
Oncolab SRL, No. 1, Craiova, , Romania
Center of Medical Oncology, Iasi, , Romania
Clinical Hospital Pelican Oradea, Oradea, , Romania
No. 1 City Hospital, Ploiesti, , Romania
"Sf. Ioan cel Nou" Clinical Emergency County Hospital, Suceava, , Romania
Clinic of Oncology - Radiotherapy, Tg. Mures, , Romania
Contact Details
Name: Leonard B Saltz, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
