KRAS Wild-type Metastatic Colorectal Cancer Trial

PHASE1CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

December 31, 2009

Primary Completion Date

January 31, 2013

Study Completion Date

January 31, 2013

Conditions
Colorectal Cancer
Interventions
DRUG

Dacogen™ (decitabine)

"Dacogen™ (decitabine) is a FDA approved drug (NDA - 021790) for the treatment of myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia).~Decitabine will be given on this study at 45 mg/m2 IV over 2 hrs"

DRUG

Vectibix® (panitumumab)

"Vectibix® (panitumumab) is a FDA approved drug (BLA-125147) indicated as a single agent for the treatment of EGFR-expressing metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine, oxaliplatin, and irinotecan chemotherapy regimens. Approval is based on progression-free survival; no data demonstrate an improvement in disease-related symptoms or increased survival.~DRUG DESCRIPTION Vectibix® (panitumumab) is a recombinant, human IgG2 kappa monoclonal antibody that binds specifically to the human epidermal growth factor receptor (EGFR). Panitumumab has an approximate molecular weight of 147 kDa. Panitumumab is produced in genetically engineered mammalian (Chinese Hamster Ovary) cells.~Panitumumab will be given on this study at 6 mg/kg, IV over 1 hr"

Trial Locations (1)

84112

Huntsman Cancer Institute, Salt Lake City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

collaborator

Eisai Inc.

INDUSTRY

lead

University of Utah

OTHER

NCT00879385 - KRAS Wild-type Metastatic Colorectal Cancer Trial | Biotech Hunter | Biotech Hunter