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


ABSTRACT: 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 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.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).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.

SUBMITTER: O'Reilly EM 

PROVIDER: S-EPMC3227926 | biostudies-literature | 2010

REPOSITORIES: biostudies-literature

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

O'Reilly Eileen M EM   Niedzwiecki Donna D   Hall Margaret M   Hollis Donna D   Bekaii-Saab Tanios T   Pluard Timothy T   Douglas Kathe K   Abou-Alfa Ghassan K GK   Kindler Hedy L HL   Schilsky Richard L RL   Goldberg Richard M RM  

The oncologist 20101210 12


<h4>Background</h4>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.<h4>Patients an  ...[more]

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