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Brief Title: Using OCZ103-OS in Patients With Unresectable and Locally Recurrent or Metastatic Colorectal Cancer Undergoing Standard Chemotherapy
Official Title: A Phase II Clinical Study Using OCZ103-OS in Patients With Unresectable and Locally Recurrent or Metastatic Colorectal Cancer Undergoing Standard Chemotherapy (mFOLFOX6 or FOLFIRI) as Second-Line Treatment
Study ID: NCT01378143
Brief Summary: The purpose of this study is to investigate the safety and efficacy of the use of OCZ103-OS in combination with standard of care as a second line treatment in subjects with unresectable and locally recurrent or metastatic colorectal cancer.
Detailed Description: This is a single arm, open label study to investigate the safety and efficacy of the use of OCZ103-OS in combination with standard therapy (mFOLFOX6 or FOLFIRI) as a second line treatment in subjects with unresectable and locally recurrent or metastatic colorectal cancer.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
CSSS Champlain - Charles-Lemoyne Hospital, Greenfield Park, Quebec, Canada
CSSS Alphonse-Desjardins (CHAU Hotel-Dieu de Levis), Levis, Quebec, Canada
CHUM-St. Luc Hospital, Montreal, Quebec, Canada
Jewish General Hospital, Montreal, Quebec, Canada
CHUS-Centre de recherche Etienne-Le Bel, Sherbrooke, Quebec, Canada
CSSS St-Jérome, St-Jérome, Quebec, Canada
Hotel-Dieu de Quebec, Quebec, , Canada
Name: Petr Kavan, MD, Ph.D.
Affiliation: Jewish General Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Benoit Samson, MD
Affiliation: CSSS Champlain - Charles-Lemoyne Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Richard Letourneau, MD
Affiliation: St. Luc Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Felix Couture, MD
Affiliation: Hotel-Dieu de Quebec
Role: PRINCIPAL_INVESTIGATOR
Name: Felix Couture, MD
Affiliation: CSSS Alphonse-Desjardins
Role: PRINCIPAL_INVESTIGATOR
Name: Annie Beaudoin, M.D.
Affiliation: CHUS-Centre de recherche Etienne-Le Bel
Role: PRINCIPAL_INVESTIGATOR
Name: Jacques Jolivet, MD
Affiliation: CSSS St-Jérome
Role: PRINCIPAL_INVESTIGATOR