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Dasatinib in Treating Patients With Previously Treated Metastatic Colorectal Cancer

2014-08-27 03:37:15 | BioPortfolio

Summary

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth.

PURPOSE: This phase II trial is studying dasatinib to see how well it works in treating patients with previously treated metastatic colorectal cancer.

Description

OBJECTIVES:

Primary

- To determine the progression-free survival of patients with metastatic colorectal cancer who have progressed on or following two prior chemotherapy regimens and are then treated with dasatinib.

Secondary

- To determine the objective response rates in patients treated with dasatinib.

- To determine the overall survival of patients treated with dasatinib.

- To determine the toxicity in patients treated with dasatinib.

Tertiary

- To determine the incidence of somatic mutations in c-src, c-yes, fyn, lck, hck, lyn, yrk and csk in archival primary and metastatic colorectal cancer tissues from these patients and to correlate this with clinical outcome.

- To determine the incidence of total c-src and phosphorylated c-src expression in archival primary and metastatic colorectal cancer specimens from these patients, and to correlate this with clinical outcome.

- To evaluate the effect of dasatinib on serum VEGF levels.

OUTLINE: This is a multicenter study.

Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Blood is collected on days 1 (prior to the first dose of dasatinib) and 15 of course 1 for measurement of VEGF pre-and post-dasatinib administration. Archived tumor tissue (tumor or core biopsy; primary or metastatic lesion) is collected for identification of the incidence of somatic mutations and polymorphisms by polymerase chain reaction and electrophoresis and for measurement of total c-src and phosphorylated src expression by immunohistochemistry.

After completion of study treatment, patients are followed for at least 8 weeks.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Colorectal Cancer

Intervention

dasatinib, gene expression analysis, mutation analysis, polyacrylamide gel electrophoresis, polymerase chain reaction, polymorphism analysis, immunohistochemistry staining method, laboratory biomarker analysis

Location

University of Chicago Cancer Research Center
Chicago
Illinois
United States
60637-1470

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:37:15-0400

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Medical and Biotech [MESH] Definitions

Polyacrylamide gel electrophoresis under conditions in which the components, such as PROTEINS, being separated can remain in their naturally folded state.

Electrophoresis in which a polyacrylamide gel is used as the diffusion medium.

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A method of detecting gene mutation by mixing PCR-amplified mutant and wild-type DNA followed by denaturation and reannealing. The resultant products are resolved by gel electrophoresis, with single base substitutions detectable under optimal electrophoretic conditions and gel formulations. Large base pair mismatches may also be analyzed by using electron microscopy to visualize heteroduplex regions.

Analysis of PEPTIDES that are generated from the digestion or fragmentation of a protein or mixture of PROTEINS, by ELECTROPHORESIS; CHROMATOGRAPHY; or MASS SPECTROMETRY. The resulting peptide fingerprints are analyzed for a variety of purposes including the identification of the proteins in a sample, GENETIC POLYMORPHISMS, patterns of gene expression, and patterns diagnostic for diseases.

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