Dasatinib in Treating Patients With Previously Treated Metastatic Colorectal Cancer

Completed · Phase 2

Conditions studied: Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer

In brief

This phase II trial is studying dasatinib to see how well it works in treating patients with previously treated metastatic colorectal cancer. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth.

Key facts

Study ID

NCT00504153

Run by

National Cancer Institute (NCI)

People needed

19

Starts

2007-07-01

Expected to finish

2011-06-01

Last updated by the study team

2014-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed colorectal cancer
• Metastatic disease
• Not curable by surgical resection
• Archival tumor tissue available
• Measurable disease, defined as at least one unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
• Measurable disease must be outside of a prior radiation port
• Documented disease progression either during or after prior chemotherapy treatment
• No more than 2 prior chemotherapy regimens in the adjuvant or metastatic setting
• Prior chemotherapy regimens must have contained a fluoropyrimidine (e.g., fluorouracil or capecitabine), oxaliplatin, and irinotecan
• Patients who received no prior adjuvant therapy must have received 2 prior chemotherapy regimens for metastatic disease (e.g., FOLFOX followed by FOLFIRI)
• Patients who received prior adjuvant therapy with a fluoropyrimidine plus oxaliplatin must have received no more than 1 chemotherapy regimen for metastatic disease that must have contained irinotecan
• VEGF or EGFR inhibitors with prior chemotherapy allowed
• No known brain metastases
• Life expectancy > 3 months
• ECOG performance status (PS) 0-2 or Karnofsky PS ≥ 60%
• WBC ≥ 3,000/mm³
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST/ALT ≤ 2.5 times ULN (5 times ULN with liver metastases)
• Creatinine normal or creatinine clearance ≥ 60 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to dasatinib

Where it is running

• University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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