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Investigational New Drugs

, Volume 24, Issue 4, pp 335–341 | Cite as

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 S. Tanaka
  • James L. Abbruzzese
Phase II Studies

Summary

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.

Keywords

Febrile Neutropenia Metastatic Colorectal Cancer Response Probability Farnesyl Advanced Colorectal Cancer 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer Science + Business Media, LLC 2006

Authors and Affiliations

  • Robert P. Whitehead
    • 1
  • Sheryl McCoy
    • 2
    • 10
  • John S. Macdonald
    • 3
  • Saul E. Rivkin
    • 4
  • Marcus A. Neubauer
    • 5
  • Shaker R. Dakhil
    • 6
  • Heinz-Josef Lenz
    • 7
  • Michael S. Tanaka
    • 8
  • James L. Abbruzzese
    • 9
  1. 1.Department of Internal MedicineUniversity of Texas Medical BranchGalveston
  2. 2.Southwest Oncology Group Statistical CenterSeattle
  3. 3.St. Vincent’s Comprehensive Cancer CenterNew York
  4. 4.Puget Sound Oncology ConsortiumSeattle
  5. 5.Kansas City Community Clinical Oncology ProgramKansas City
  6. 6.Wichita Community Clinical Oncology ProgramWichita
  7. 7.USC/Norris Comprehensive Cancer CenterLos Angeles
  8. 8.University of California Davis Cancer CenterSacramento
  9. 9.University of Texas M.D. Anderson Cancer CenterHouston
  10. 10.Operations OfficeSouthwest Oncology Group (SWOG-S9923)San Antonio

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