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Gemcitabine plus sorafenib in patients with advanced pancreatic cancer: a phase II trial of the University of Chicago Phase II Consortium
Open accessAbstract
Background Sorafenib, an inhibitor of B-raf, VEGFR2, and PDGFR-β, has activity against pancreatic cancer in preclinical models. In a phase I trial of gemcitabine plus sorafenib, 57% of pancreatic cancer patients achieved stable disease.Patients and methods We conducted a multi-center phase II trial of sorafenib plus gemcitabine in chemo-naïve patients with histologically-confirmed, advanced pancreatic cancer. Patients received sorafenib 400 mg twice daily and gemcitabine 1,000 mg/m(2) on days 1, 8 and 15 of a 28 day cycle.Results Seventeen patients enrolled at 4 centers; 13 were evaluable for response. There were no objective responses; 18% had stable disease. Median overall survival was 4.0 months (95% CI: 3.4, 5.9); median progression-free survival was 3.2 months (95% CI: 1.6, 3.6). Grade 3/4 toxicities included thrombosis in 18% of patients, dehydration or hand-foot syndrome in 12%, and hypertension or gastrointestinal bleeding in 6%.Conclusion Gemcitabine plus sorafenib is inactive in advanced pancreatic cancer.
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Metadata
- Authors
- Kindler, H. L., Wroblewski, K., Wallace, J. A., Hall, M. J., Locker, G., Nattam, S., Agamah, E., Stadler, W. M., & Vokes, E. E.
- Affiliations
- University of Chicago (US)
- Endeavor Health (US)
- Fort Wayne Medical Institute (US)
- Corresponding author
- Kindler, Hedy Lee
- ORCID
- Venue
- Investigational New Drugs
- Published
- 2010-08-28
- Volume
- 30
- Issue
- 1
- Pages
- 382-386
- ISSN
- 0167-6997 (ISSN-L)
- 1573-0646
- PMC
- PMC4319645
- OpenAlex
- W2061953474
- Cited by
- 103
- References
- 26
- Citations by year
- 2025: 2 · 2024: 3 · 2023: 7 · 2022: 6 · 2021: 8 · 2020: 6 · 2019: 6 · 2018: 8 · 2017: 6 · 2016: 6 · 2015: 8 · 2014: 7 · 2013: 12 · 2012: 9
- FWCI
- 4.74
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Licence
- Locations
- Investigational New Drugs (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (n01cm62201-16-0-1)
- National Cancer Institute (N01 CM062201, N01 CM-62201)
- Topics
- Health Sciences › Medicine › Oncology › Pancreatic and Hepatic Oncology Research
- Health Sciences › Medicine › Surgery › Pancreatitis Pathology and Treatment
- Health Sciences › Medicine › Oncology › Cancer Treatment and Pharmacology
- Keywords
- gemcitabine, sorafenib, advanced pancreatic cancer, combination chemotherapy, VEGFR-2 inhibition, chemotherapy-naive patients, stable disease, thrombosis, hand-foot syndrome, overall survival, progression-free survival
- MeSH terms
- Sorafenib, Gemcitabine, Adenocarcinoma, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Benzenesulfonates, Chicago, Deoxycytidine, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Niacinamide, Pancreatic Neoplasms, Phenylurea Compounds, Pyridines, Time Factors, Universities, Treatment Outcome, Disease-Free Survival, Kaplan-Meier Estimate
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