scholarly journals Phase II Trial of Cetuximab, Gemcitabine, and Oxaliplatin Followed by Chemoradiation With Cetuximab for Locally Advanced (T4) Pancreatic Adenocarcinoma: Correlation of Smad4(Dpc4) Immunostaining With Pattern of Disease Progression

2011 ◽  
Vol 29 (22) ◽  
pp. 3037-3043 ◽  
Author(s):  
Christopher H. Crane ◽  
Gauri R. Varadhachary ◽  
John S. Yordy ◽  
Gregg A. Staerkel ◽  
Milind M. Javle ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Disease Progression ◽  
Phase Ii ◽  
Radiation Treatment ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Survival Duration ◽  
Acneiform Rash

Purpose This phase II trial was designed to assess the efficacy and safety of cetuximab, gemcitabine, and oxaliplatin followed by cetuximab, capecitabine, and radiation therapy in locally advanced pancreatic cancer (LAPC). Patients and Methods Treatment-naive eligible patients (n = 69) received intravenous gemcitabine (1,000 mg/m2) and oxaliplatin (100 mg/m2) every 2 weeks for four doses, followed by radiation (50.4 Gy to the gross tumor only) with concurrent capecitabine (825 mg/m2 twice daily on radiation treatment days). Cetuximab (500 mg/m2) was started on day 1 of chemotherapy and was continued every 2 weeks during chemotherapy and chemoradiotherapy. Diagnostic cytology specimens were immunostained for Smad4(Dpc4) expression. Results Median overall survival time was 19.2 months (95% CI, 14.2 to 24.2 months), and 1-year, 2-year, and 4-year actuarial overall survival rates were 66.0%, 25.02%, and 11.3%, respectively. Acneiform rash correlated with improved survival (P = .001), but initial CA19-9, borderline resectable initial stage, and surgical resection (n = 7) did not. The 1-year and 2-year radiographic local progression rates were 22.8% and 61.0%, respectively. The worst acute toxic effects were GI toxicity (32% and 10% for grades 2 and 3, respectively); fatigue (26% and 6% for grades 2 and 3, respectively); sensory neuropathy (9% and 1% for grades 2 and 3, respectively); and acneiform rash (54% and 3% for grades 2 and 3, respectively). Smad4(Dpc4) expression correlated with a local rather than a distant dominant pattern of disease progression (P = .016). Conclusion This regimen appears effective and has acceptable toxicity. The primary end point (1-year overall survival rate > 45%) was met, with encouraging survival duration. Smad4(Dpc4) immunostaining correlated with the pattern of disease progression. Prospective validation of Smad4(Dpc4) expression in cytology specimens as a predictive biomarker is warranted and may lead to personalized treatment strategies for patients with localized pancreatic cancer.

Phase II trial of 5-fluorouracil, adriamycin and cisplatin (FAP) followed by radiation and 5-fluorouracil in locally advanced pancreatic cancer

1989 ◽  
Vol 25 (2) ◽  
pp. 131-134 ◽  
Author(s):  
D. J. TH. Wagener ◽  
Q. G. C. M. van Hoesel ◽  
S. H. Yap ◽  
W. J. Hoogenraad ◽  
Th. Wobbes ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Locally Advanced Pancreatic Cancer

A phase II trial of gemcitabine in combination with oxaliplatin and capecitabine in previously untreated metasetatic or recurrent pancreatic cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14685-e14685
Author(s):  
Sun Jin Sym ◽  
Junsik Hong ◽  
Minkyu Jung ◽  
Yang Seo Koo ◽  
Yeon Ho Park ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Disease Progression ◽  
Pancreatic Adenocarcinoma ◽  
Single Agent ◽  
Objective Response ◽  
Survival Rates ◽  
Advanced Pancreatic Cancer ◽  
Survival Duration ◽  
One Year

e14685 Background: Treatment with single agent gemcitabine provides modest benefits in patients with metastatic pancreatic cancer.This study was performed to determine the efficacy of gemcitabine in combination with oxaliplatin and capecitabine in patient with recurrent or metastatic pancreatic adenocarcinoma. Methods: This was a prospective, single-arm, single center study in patients with chemotherapy-naive metastatic or recurrent pancreatic adenocarcinoma. The primary endpoint was objective response. The study was designed as a Simons two-stage optimal design and was divided into two stages. The first stage was to recruit up to 18 patients. If at least two objective responses were obtained, then a further 25 patients would be enrolled into the study. If no more than two responses were obtained among these 18 patients, the study would be halted. The study patients received gemcitabine 800 mg/m2 on day1, plus oxaliplatin 100 mg/m2 on day 1 and capecitabine 800 mg/m2/day on days 1-7 every 14 days. Treatment was to be administered until disease progression or until withdrawal from the study due to unacceptable toxicity or other reasons. Results: Eighteen patients were enrolled. Median age was 63 years (range, 39-73 years). Among these 18 patients, only one patient (5.5%) achieved an objective response. Therefore, the accrual terminated. The median time to disease progression was 2.1 months, and the median overall survival duration was 4.9 months. One-year overall survival rates were 35.3%. The most frequently reported grade 3 or 4 adverse events were asthenia (16.6%), and nausea (5.5%). There were no unexpected toxicities. Conclusions: The addition of oxaliplatin and capecitabine to gemcitabine did not improve objective response in the first-line treatment of advanced pancreatic cancer patients.

A phase II trial of gemcitabine in combination with oxaliplatin and capecitabine in previously untreated metastatic or recurrent pancreatic cancer.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 344-344
Author(s):  
Sun Jin Sym ◽  
Junsik Hong ◽  
Minkyu Jung ◽  
Yang Seo Koo ◽  
Yeon Ho Park ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Disease Progression ◽  
Pancreatic Adenocarcinoma ◽  
Single Agent ◽  
Objective Response ◽  
Survival Rates ◽  
Advanced Pancreatic Cancer ◽  
Survival Duration ◽  
One Year

344 Background: Treatment with single agent gemcitabine provides modest benefits in patients with metastatic pancreatic cancer. This study was performed to determine the efficacy of gemcitabine in combination with oxaliplatin and capecitabine in patient with recurrent or metastatic pancreatic adenocarcinoma. Methods: This was a prospective, single-arm, single center study in patients with chemotherapy-naive metastatic or recurrent pancreatic adenocarcinoma. The primary endpoint was objective response. The study was designed as a Simons two-stage optimal design and was divided into two stages. The first stage was to recruit up to 18 patients. If at least two objective responses were obtained, then a further 25 patients would be enrolled into the study. If no more than two responses were obtained among these 18 patients, the study would be halted. The study patients received gemcitabine 800 mg/m2, plus oxaliplatin 100 mg/m2 and capecitabine 800 mg/m2/day on days 1-7 every 14 days. Treatment was to be administered until disease progression or until withdrawal from the study due to unacceptable toxicity or other reasons. Results: Eighteen patients were enrolled. Median age was 63 years (range, 39-73 years). Among these 18 patients, only one patient (5.5%) achieved an objective response. Therefore, the accrual terminated. The median time to disease progression was 2.1 months, and the median overall survival duration was 4.9 months. One-year overall survival rates were 35.3%. The most frequently reported grade 3 or 4 adverse events were asthenia (16.6%), and nausea (5.5%). There were no unexpected toxicities. Conclusions: The addition of oxaliplatin and capecitabine to gemcitabine did not improve objective response in the first-line treatment of advanced pancreatic cancer patients.

Phase II trial of S-1 and concurrent radiotherapy in patients with locally advanced pancreatic cancer

2008 ◽  
Vol 63 (3) ◽  
pp. 535-541 ◽  
Author(s):  
Hee Man Kim ◽  
Seungmin Bang ◽  
Jeong Youp Park ◽  
Jinsil Seong ◽  
Si Young Song ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Locally Advanced Pancreatic Cancer ◽  
Concurrent Radiotherapy
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