A phase II trial of Erlotinib in combination with gemcitabine and cisplatin in advanced pancreatic cancer

• Published in: Investigational new drugs 2012-12, Vol.30 (6), p.2371-2376
• Main 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
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antineoplastic Agents - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Cancer therapies; Chemotherapy; Cisplatin - administration & dosage; Clinical trials; Combination therapy; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Disease control; Drug dosages; Erlotinib Hydrochloride; Female; Humans; Internal medicine; Male; Medicine; Medicine & Public Health; Metastasis; Middle Aged; Oncology; Pancreatic cancer; Pancreatic Neoplasms - drug therapy; Pharmacology; Pharmacology/Toxicology; Phase II Studies; Quinazolines - administration & dosage; Response rates; Studies; Toxicity; University colleges
• ISSN: 0167-6997; 1573-0646
• DOI: 10.1007/s10637-012-9792-z

Summary 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-naïve 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 (≥3/22, 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).