Skip to main content
Journal cover image

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

Publication ,  Journal Article
Whitehead, RP; McCoy, S; Macdonald, JS; Rivkin, SE; Neubauer, MA; Dakhil, SR; Lenz, H-J; Tanaka, MS; Abbruzzese, JL; Southwest Oncology Group,
Published in: Invest New Drugs
July 2006

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 21 days 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.

Duke Scholars

Published In

Invest New Drugs

DOI

ISSN

0167-6997

Publication Date

July 2006

Volume

24

Issue

4

Start / End Page

335 / 341

Location

United States

Related Subject Headings

  • Survival Analysis
  • Southwestern United States
  • Quinolones
  • Oncology & Carcinogenesis
  • Neoplasm Staging
  • Middle Aged
  • Male
  • Humans
  • Female
  • Dose-Response Relationship, Drug
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Whitehead, R. P., McCoy, S., Macdonald, J. S., Rivkin, S. E., Neubauer, M. A., Dakhil, S. R., … Southwest Oncology Group, . (2006). Phase II trial of R115777 (NSC #70818) in patients with advanced colorectal cancer: a Southwest Oncology Group study. Invest New Drugs, 24(4), 335–341. https://doi.org/10.1007/s10637-005-4345-3
Whitehead, Robert P., Sheryl McCoy, John S. Macdonald, Saul E. Rivkin, Marcus A. Neubauer, Shaker R. Dakhil, Heinz-Josef Lenz, Michael S. Tanaka, James L. Abbruzzese, and James L. Southwest Oncology Group. “Phase II trial of R115777 (NSC #70818) in patients with advanced colorectal cancer: a Southwest Oncology Group study.Invest New Drugs 24, no. 4 (July 2006): 335–41. https://doi.org/10.1007/s10637-005-4345-3.
Whitehead RP, McCoy S, Macdonald JS, Rivkin SE, Neubauer MA, Dakhil SR, et al. Phase II trial of R115777 (NSC #70818) in patients with advanced colorectal cancer: a Southwest Oncology Group study. Invest New Drugs. 2006 Jul;24(4):335–41.
Whitehead, Robert P., et al. “Phase II trial of R115777 (NSC #70818) in patients with advanced colorectal cancer: a Southwest Oncology Group study.Invest New Drugs, vol. 24, no. 4, July 2006, pp. 335–41. Pubmed, doi:10.1007/s10637-005-4345-3.
Whitehead RP, McCoy S, Macdonald JS, Rivkin SE, Neubauer MA, Dakhil SR, Lenz H-J, Tanaka MS, Abbruzzese JL, Southwest Oncology Group. Phase II trial of R115777 (NSC #70818) in patients with advanced colorectal cancer: a Southwest Oncology Group study. Invest New Drugs. 2006 Jul;24(4):335–341.
Journal cover image

Published In

Invest New Drugs

DOI

ISSN

0167-6997

Publication Date

July 2006

Volume

24

Issue

4

Start / End Page

335 / 341

Location

United States

Related Subject Headings

  • Survival Analysis
  • Southwestern United States
  • Quinolones
  • Oncology & Carcinogenesis
  • Neoplasm Staging
  • Middle Aged
  • Male
  • Humans
  • Female
  • Dose-Response Relationship, Drug