A Cancer and Leukemia Group B phase II study of sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma (CALGB 80603).


Journal Article

BACKGROUND: The Cancer and Leukemia Group B (CALGB) conducted a phase II study evaluating sunitinib in patients with progressive metastatic pancreas adenocarcinoma following prior gemcitabine-based therapy (trial CALGB 80603; ClinicalTrials.gov identifier, NCT00397787). The primary endpoint was to determine the disease control rate (DCR) as measured by the Response Evaluation Criteria in Solid Tumors (complete response, partial response [PR], and stable disease) at 6 weeks. PATIENTS AND METHODS: Patients aged ≥18 years with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 and with progressive pancreas adenocarcinoma following treatment with gemcitabine were eligible. Sunitinib was dosed at 50 mg orally days 1-28, every 42 days (1 cycle). The statistical plan called for a three-stage design. A DCR ≥15% was considered worthy of further study. RESULTS: In total, 77 patients were enrolled. Forty-two (54.6%) enrollees were male. The median age was 65 years. The ECOG performance status score distribution was: 0, 39%; 1, 50%; 2, 11%. The DCR was 21.6%; one patient (1.4%) had a PR and 15 patients (20.3%) had stable disease as their best response. The progression-free survival time was 1.31 months (95% confidence interval [CI] 1.25-1.38 months) and overall survival time was 3.68 months (95% CI, 3.06-4.24 months). CONCLUSIONS: The study met its primary endpoint; however sunitinib had minimal activity and moderate toxicity in a population of gemcitabine-refractory pancreas adenocarcinoma patients. For future studies, limiting enrollment to patients with an ECOG performance status score of 0-1 is recommended.

Full Text

Duke Authors

Cited Authors

  • O'Reilly, EM; Niedzwiecki, D; Hall, M; Hollis, D; Bekaii-Saab, T; Pluard, T; Douglas, K; Abou-Alfa, GK; Kindler, HL; Schilsky, RL; Goldberg, RM; Cancer and Leukemia Group B,

Published Date

  • 2010

Published In

Volume / Issue

  • 15 / 12

Start / End Page

  • 1310 - 1319

PubMed ID

  • 21148613

Pubmed Central ID

  • 21148613

Electronic International Standard Serial Number (EISSN)

  • 1549-490X

Digital Object Identifier (DOI)

  • 10.1634/theoncologist.2010-0152


  • eng

Conference Location

  • United States