Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone

PHASE2CompletedINTERVENTIONAL
Enrollment

171

Participants

Timeline

Start Date

May 31, 2009

Primary Completion Date

May 31, 2012

Study Completion Date

March 31, 2013

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

CT-011

DRUG

FOLFOX

"FOLFOX-4: each cycle consists of the following: oxaliplatin 85 mg/m2 on Day 1, leucovorin 200 mg/m2/day on Day 1 and Day 2 followed by 5-FU 400 mg/m2 bolus and a 22 hour infusion of 5-FU 600 mg/m2 for two consecutive days.~mFOLFOX-6: each cycle consists of the following: oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 on Day 1, followed by 5-FU 400 mg/m2 bolus, followed by 5-FU 1200 mg/m2/day for two consecutive days (total 2,400 mg/m2 over 46-48 hours)."

Trial Locations (31)

10017

Memorial Sloan-Kettering Cancer Center, New York

33606

University of South Florida, Tampa

35801

The Cancer Center of Huntsville, PC, Huntsville

45042

Signal Point Clinical Research Center, Middletown

79410

Joe Arrington Cancer Research and Treatment Center, Lubbock

200535

Oncolab SRL, No. 1, Craiova

400015

"Prof. Dr. Ion Chiricuţă Institute of Oncology", Cluj-Napoca

410469

Clinical Hospital Pelican Oradea, Oradea

411001

Ruby Hall Clinic, Pune

411004

Deenanath Mangeshkar Hospital and Research Centre, Pune

422004

Curie Manavata Cancer Centre, Opp., Nashik

440012

Cancer Clinic, Nagpur

540141

Clinic of Oncology - Radiotherapy, Tg. Mures

641037

G. Kuppuswamy Naidu Memorial Hospital, Pappanaickenpalayam, Coimbatore

900591

Clinical Emergency Hospital - Oncology Department, Constanța

Unknown

"MHAT Dr. Tota Venkova", Gabrovo

InterDistrict Dispensary in Oncology Diseases with Stationary-Ruse, EOOD, Rousse

InterDistrict Dispensary in Oncology Diseases with Stationary, Shumen

"Multiprofile Hospital for Active Treatment Tsaritza Joanna", Sofia

Specialized Hospital for Active Treatment for Oncology, Sofia

InterDistrict Dispensary of Oncology Diseases with Stationary, Varna

"Multiprofile Hospital for Active Treatment Sv. Marina, EAD,", Varna

Hospital Almanzor Aguinaga Asenjo - Chiclayo, Chiclayo

Clinica Ricardo Palma, Lima

Hospital Regional nivel III Cayetano Heredia Essalud Piura, Piura

Center of Medical Oncology, Iași

No. 1 City Hospital, Ploieşti

"Sf. Ioan cel Nou Clinical Emergency County Hospital", Suceava

800 014

Regional Cancer Centre, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna

00716

Ponce School of Medicine/CAIMED Center, Ponce

00909

Fundacion de Investigacion de Diego, Santurce

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Medivation, Inc.

INDUSTRY

NCT00890305 - Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone | Biotech Hunter | Biotech Hunter