A phase II trial of Erlotinib in combination with gemcitabine and cisplatin in advanced pancreatic cancer
- Authors
- Hwang, In Gyu; Jang, Joung-Soon; Oh, Sung Yong; Lee, Suee; Kwon, Hyuk Chan; Lee, Gyeong Won; Go, Seil; Kang, Myoung Hee; Cha, Young Joo; Kang, Jung Hun
- Issue Date
- Dec-2012
- Publisher
- SPRINGER
- Keywords
- Advanced pancreatic carcinoma; Cisplatin; Erlotinib; Gemcitabine
- Citation
- INVESTIGATIONAL NEW DRUGS, v.30, no.6, pp 2371 - 2376
- Pages
- 6
- Journal Title
- INVESTIGATIONAL NEW DRUGS
- Volume
- 30
- Number
- 6
- Start Page
- 2371
- End Page
- 2376
- URI
- https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/19951
- DOI
- 10.1007/s10637-012-9792-z
- ISSN
- 0167-6997
1573-0646
- Abstract
- Background Gemcitabine has been recognized as a standard chemotherapy in advanced pancreas cancer (APC). We conducted a phase II study of a triple combination regimen (GPT) consisting of gemcitabine (G), cisplatin (P) and erlotinib (T) in patients with APC. Patients and methods Chemotherapy-na < ve patients with locally advanced or metastatic, histologically confirmed adenocarcinoma of the pancreas were treated with erlotinib 100 mg daily, 1,000 mg/m(2) of gemcitabine and 25 mg/m(2) of cisplatin administered on days 1 and 8, respectively, every 3 weeks. The primary end point was objective response. Secondary end points included progression-free survival, overall survival and toxicity. The study was designed according to the optimal two-stage design. Results Twenty-two patients were enrolled between June 2009 and August 2010. No complete response was achieved and partial response was observed in 5 patients (26%), Stable disease in 7 (37%), and progressive disease in 7 (37%). The median time to progression was 4.0 months (95% CI: 2.9-5.1 months), and the median overall survival 6.8 months (95% CI: 3.7-9.9 months). The response rate in stage I reached the target (a parts per thousand yen3/22, p0 = 10%) established for movement to stage II but this study was determined to close earlier than planned because of unexpected treatment-related deaths (3 patients). Conclusion The triple regimen of GPT is effective for APC. Treatment-related mortalities factored early closure of this GPT protocol. Considering effect and toxicity, this triple regimen seems to offer few benefits to the patients compared with gemcitabine-based doublets. (ClinicalTrials.gov number, NCT00922896).
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