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Phase II trial of depsipeptide (NSC-630176) in colorectal cancer patients who have received either one or two prior chemotherapy regimens for metastatic or locally advanced, unresectable disease: A Southwest Oncology Group study.

3598 The treatment for metastatic colorectal cancer has markedly improved but the disease is still not curable, and additional active agents need to be found. Depsipeptide is a histone deacetylase inhibitor that has shown activity against human solid tumor cell lines and promising results in murine model systems. This phase II trial was undertaken to determine its activity in patients with advanced colorectal cancer. Eligibility requirements included measurable disease, either metastatic or locally advanced and not surgically resectable, Zubrod performance status of 0-1, and adequate renal, hepatic, hematologic and cardiac function. Prior surgery or radiation therapy was allowed and patients were required to have received either one or two prior chemotherapy regimens for advanced disease. A two-stage design was used designed to detect a difference in the null hypothesis of 5% response vs. an alternative 20% response, with 20 eligible patients to be accrued initially followed by an additional 20 patients if one or more confirmed responses were observed. The study closed after the first stage, with 28 patients registered. Three patients are ineligible, two who did not meet requirements for serum magnesium level, and one whose baseline labs were performed more than 14 days prior to registration. One eligible patient never received treatment and is not analyzable for any endpoint. For the 24 eligible and analyzable patients, median age was 58.6 years (range 31-84) with 14 males. Performance status was 0 in 16 patients and 1 in 8. Ten patients received 1 prior chemotherapy regimen and 14 received 2 prior regimens. There were no grade 4 or higher toxicities. The most common grade 2 or 3 toxicities were anorexia, fatigue, nausea, and dehydration. No objective responses were observed. Four patients had stable disease, 15 showed increasing disease, 3 had symptomatic deterioration, and 2 had assessment inadequate. The current Kaplan-Meier estimate of 6 month overall survival is 69% (95% CI 50%-88%) with a median survival of 8.4 months. Depsipeptide does not show significant anti-tumor activity in previously treated patients with advanced colorectal cancer. No significant financial relationships to disclose.