Abstract | BACKGROUND: PATIENTS AND METHODS: Eligibility criteria included locally advanced or metastatic pancreatic adenocarcinoma and previous treatment with gemcitabine. The study was a single arm phase II trial using a Simon 2-stage design. The primary endpoint was response rate, secondary endpoints included time to progression and overall survival. RESULTS: Fifteen patients were enrolled, 14 received treatment, and 12 were evaluable for response. The median age was 61, and the majority of patients were ECOG performance status 1. Grade 3 or greater adverse events included neutropenia (29%), fatigue (14%), peripheral neuropathy (7%) and thrombosis (7%). There were no complete or partial responses and therefore the study was closed after the first stage. The best response was stable disease in 5/12 (42%) of patients. Of these five patients, three had stable disease for 9 months or greater. Median time to progression was 1.4 months, and median overall survival was 6.1 months. CONCLUSION:
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Authors | Daniel J Renouf, Patricia A Tang, Pierre Major, Monika K Krzyzanowska, Bindi Dhesy-Thind, John R Goffin, David Hedley, Lisa Wang, L Doyle, Malcolm J Moore |
Journal | Investigational new drugs
(Invest New Drugs)
Vol. 30
Issue 3
Pg. 1203-7
(Jun 2012)
ISSN: 1573-0646 [Electronic] United States |
PMID | 21526355
(Publication Type: Clinical Trial, Phase II, Journal Article)
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Chemical References |
- Antineoplastic Agents
- Ethers, Cyclic
- Furans
- Ketones
- Macrolides
- Tubulin Modulators
- Deoxycytidine
- halichondrin B
- eribulin
- Gemcitabine
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Topics |
- Adult
- Aged
- Antineoplastic Agents
(adverse effects, therapeutic use)
- Deoxycytidine
(analogs & derivatives)
- Drug Resistance, Neoplasm
- Ethers, Cyclic
- Female
- Furans
(adverse effects, therapeutic use)
- Humans
- Ketones
(adverse effects, therapeutic use)
- Macrolides
- Male
- Middle Aged
- Pancreatic Neoplasms
(drug therapy)
- Tubulin Modulators
(adverse effects, therapeutic use)
- Gemcitabine
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