Phase II trial of R115777 (NSC #70818) in patients with advanced colorectal cancer: A Southwest Oncology Group study

Robert P. Whitehead, Sheryl McCoy, John S. Macdonald, Saul E. Rivkin, Marcus A. Neubauer, Shaker R. Dakhil, Heinz Josef Lenz, Michael Tanaka, James L. Abbruzzese

Research output: Contribution to journalArticle

10 Scopus citations

Abstract

Purpose: The purpose of this Phase II multi-institutional trial was to determine the efficacy and toxicity of R115777 in previously untreated patients with metastatic colorectal carcinoma. Patients and methods: Patients were required to have histologically confirmed colorectal cancer with distant metastatic disease that was not surgically curable. They could not have received prior chemotherapy for metastatic disease. R115777 was given at a dose of 300 mg p.o. twice a day for 21days every 28 days until tumor progression or toxicity or other reason for discontinuation occurred. The primary endpoint was to determine the confirmed response probability with this treatment. Results: There were 55 eligible patients accrued to the study. There were no complete responses, but one confirmed partial response for a confirmed response probability of 2% (95%CI 0-10%). Three additional patients had an unconfirmed partial response for an overall response probability of 7%. The time to treatment failure was 1.7 months and the estimated median survival was 8.1 months. One patient died of treatment related infection and there were 7 other patients with grade 4 toxicities consisting of neutropenia, leukopenia, febrile neutropenia and thrombocytopenia, depression, increased bilirubin, anemia, and pneumonitis/infiltrates. Conclusion: R115777 given as a single agent by this dose and schedule is ineffective in patients with metastatic colorectal cancer.

Original languageEnglish (US)
Pages (from-to)335-341
Number of pages7
JournalInvestigational New Drugs
Volume24
Issue number4
DOIs
StatePublished - Jul 2006

Keywords

  • Colorectal cancer
  • Phase II trial
  • R115777
  • Southwest Oncology Group

ASJC Scopus subject areas

  • Molecular Medicine
  • Pharmacology

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    Whitehead, R. P., McCoy, S., Macdonald, J. S., Rivkin, S. E., Neubauer, M. A., Dakhil, S. R., Lenz, H. J., Tanaka, M., & Abbruzzese, J. L. (2006). Phase II trial of R115777 (NSC #70818) in patients with advanced colorectal cancer: A Southwest Oncology Group study. Investigational New Drugs, 24(4), 335-341. https://doi.org/10.1007/s10637-005-4345-3