Cetuximab & Celecoxib for Metastatic Colorectal Cancer or Colorectal Cancer That Cannot Be Removed by Surgery

PHASE2CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

May 31, 2005

Primary Completion Date

July 31, 2008

Study Completion Date

November 30, 2008

Conditions
Colorectal Cancer
Interventions
BIOLOGICAL

cetuximab

400 mg/m2 iv week 1, then 250 mg/m2 weekly thereafter, starting on day 1 and continuing until progressive disease, excessive toxicity or removal from study for other reasons listed in the protocol.

DRUG

celecoxib

200 mg po BID starting on day 1 and continuing until progressive disease, excessive toxicity or removal from study for other reasons listed in the protocol.

GENETIC

proteomic profiling

Serum samples obtained as above will be analyzed by proteomic analysis in order to determine biomarkers of treatment response and toxicity prediction. We will use LC-MS-MS or MALDITOF mass spectrometry.

OTHER

immunohistochemistry staining method

phospho-EGFR levels using western blots of tissue extracts and immunohistochemistry on frozen and (if no other option available, paraffinembedded tissue sections).

OTHER

laboratory biomarker analysis

Serum samples obtained as above will be analyzed by proteomic analysis in order to determine biomarkers of treatment response and toxicity prediction.

OTHER

mass spectrometry

We will use LC-MS-MS or MALDITOF mass spectrometry. Before any tissues are received, the drug of interest is evaluated via MALDI mass spectrometry on a MDS/Sciex QStar QqTOF mass spectrometer.

Trial Locations (1)

37232

Vanderbilt-Ingram Cancer Center, Nashville

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Vanderbilt-Ingram Cancer Center

OTHER

NCT00466505 - Cetuximab & Celecoxib for Metastatic Colorectal Cancer or Colorectal Cancer That Cannot Be Removed by Surgery | Biotech Hunter | Biotech Hunter