Cetuximab in combination with intensity modulated radiotherapy (IMRT) and gemcitabine for patients with locally advanced pancreatic cancer: A prospective phase II trial [PARC-Study ISRCTN56652283]

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4573-4573 ◽  
Author(s):  
R. Krempien ◽  
M. W. Munter ◽  
C. Timke ◽  
H. Friess ◽  
G. Hartung ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Pancreatic Adenocarcinoma ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Intensity Modulated Radiotherapy ◽  
Locally Advanced Pancreatic Cancer ◽  
Trimodal Therapy ◽  
Prospective Phase

4573 Background: The induction of EGFR targeting with cetuximab in radiation based therapy of solid tumors has yielded promising results. Thus, we initiated a prospective phase II trial designed to analyze the feasibility and effectivity of trimodal therapy with gemcitabine-based chemoradiation and cetuximab in locally advanced inoperable pancreatic cancer. Methods: In this phase 2 study, pts with locally advanced pancreatic cancer without prior cytotoxic therapy were treated with radiotherapy (RT), gemcitabine weekly (300mg/m2), and cetuximab weekly (loading dose 400mg/m2 day 1, and concomitant with radiation day 8,15,22,29,36 250mg/m2). RT was delivered by using an integrated IMRT boost concept (54 Gy GTV, 45 Gy CTV) over 5 weeks. RT was followed by gemcitabine (1,000mg/m2) weekly x 3 in 4 weeks. Response evaluation using CT followed at week 12. All pts were intended for surgical treatment between week 12–15. Pts were followed for adverse events and response. Results: 55 pts were enrolled. Preliminary results are presented on 36 pts with the following characteristics: pancreatic adenocarcinoma c2 T4 N1 36/36, median age = 61.5 (range 48–79); M/F = 24/12; ECOG PS 0/1/2 = 6/26/4; median days on treatment: 90 (range 70–100). Treatment-related toxicities were observed in 22 pts. Grade 3 toxicities included diarrhea (n=5), fatigue (n=4), nausea (n=6), neutropenia (n=10), thrombocytopenia (n=4), and vomiting (n=4). 34/36 pts developed some acneiforme rush during therapy. No omittance of cetuximab was necessary in any of the pts. 1 patient died during treatment due to tumor bleeding. Median follow-up at present is 13 month, 1-year survival was 57%, median survival has not been reached. Partial remissions 12/36, stable disease 20/36, progressive disease 4/36 (RECIST). 21/36 pts were amenable for secondary potentially curative resection. 9 pts could be resected, while 8 pts were found to have abdominal metastatic spread. Conclusions: Early data from trimodal therapy in pancreatic adenocarcinoma with chemoradiation (IMRT), gemcitabine, and cetuximab indicate feasibility without increased toxicity profile. The local response appears to be very promising in pancreatic cancer. [Table: see text]

Phase II study evaluating trimodal therapy with cetuximab intensity modulated radiotherapy (IMRT) and gemcitabine for patients with locally advanced pancreatic cancer [ISRCTN56652283]

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4100-4100 ◽  
Author(s):  
R. C. Krempien ◽  
M. W. Münter ◽  
C. Timke ◽  
P. E. Huber ◽  
H. Friess ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Pancreatic Adenocarcinoma ◽  
Phase Ii ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Advanced Pancreatic Cancer ◽  
Intensity Modulated Radiotherapy ◽  
Locally Advanced Pancreatic Cancer ◽  
Trimodal Therapy ◽  
Tumor Bleeding

4100 Background: The induction of EGFR targeting with cetuximab in radiation based therapy of solid tumors has yielded promising results. Thus, we initiated a prospective Phase II trial designed to analyze the feasibility and effectivity of trimodal therapy with gemcitabine-based chemoradiation and cetuximab in locally advanced inoperable pancreatic cancer. Methods: In this phase 2 study, pts with locally advanced pancreatic cancer without prior cytotoxic therapy were treated with radiotherapy (RT), gemcitabine weekly (300 mg/m2), and cetuximab weekly (loading dose 400 mg/m2 day 1, and concomitant with radiation day 8,15,22,29,36 250 mg/m2). RT was delivered by using an integrated IMRT boost concept (54 Gy GTV, 45 Gy CTV) over 5 weeks. RT was followed by gemcitabine (1000 mg/m2) weekly × 3 in 4 weeks. Response evaluation using computed tomography followed at week 12. All amenable patients were intended for surgical treatment between week 12–15. Results: 24 pts were enrolled until now. Preliminary results are presented on 20 pts with the following characteristics: pancreatic adenocarcinoma c2 T4 N1 20/20, median age = 63.5 (range 51–79); M/F = 13/7; ECOG PS 0/1/2 = 2/12/6; median days on treatment: 90 (range 70–100). Treatment-related toxicities were observed in 16 pts. Grade 3 toxicities included diarrhea (n = 4), fatigue (n = 2), nausea (n = 3), neutropenia (n = 6), thrombocytopenia (n = 2), and vomiting (n = 2). 18/20 pts developed some acneiforme rush during therapy. No omittance of cetuximab therapy was necessary. 1 patient died during RT due to tumor bleeding. Median follow-up at present is 6 month, median survival has not been reached. Partial remissions 8/20, stable disease 9/20, progressive disease 3/20. 12/20 patients were amenable for secondary potentially curative resection. 4 patients could be resected, while 3 patients were found to have abdominal metastatic spread. Conclusions: Early data from trimodal therapy in pancreatic adenocarcinoma with chemoradiation (IMRT), gemcitabine, and cetuximab indicate feasibility without increased toxicity profile. The local response appears to be very promising in pancreatic cancer, potentially allowing neoadjuvant treatment. [Table: see text]

Resection of locally advanced pancreatic cancer after neoadjuvant chemotherapy with modified FOLFIRINOX: A prospective phase II study

Pancreatology ◽  
2013 ◽  
Vol 13 (3) ◽  
pp. S88-S89
Author(s):  
Nelide De Lio ◽  
Enrico Vasile ◽  
Mario Antonio Belluomini ◽  
Francesca Costa ◽  
Carla Cappelli ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Locally Advanced Pancreatic Cancer ◽  
Prospective Phase

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 study of neoadjuvant gemcitabine/5-fluorouracil followed by 5-fluorouracil/oxaliplatin concurrent with radiation in patients with locally advanced pancreatic cancer.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 259-259
Author(s):  
C. Lin ◽  
B. M. Kos ◽  
A. R. Sasson ◽  
J. L. Meza ◽  
J. L. Grem
Keyword(s):  
Pancreatic Cancer ◽  
Continuous Infusion ◽  
Pancreatic Adenocarcinoma ◽  
Phase Ii ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Locally Advanced Pancreatic Cancer ◽  
R0 Resection ◽  
Borderline Resectable ◽  
R1 Resection

259 Background: We designed this phase II trial to determine the efficacy and safety of a neoadjuvant regimen involving gemcitabine, infusional 5-fluorouracil (5-FU), oxaliplatin and radiation therapy (RT) in patients with locally advanced pancreatic adenocarcinoma Methods: Induction chemotherapy (CT) consisted of two 3-week cycles of weekly gemcitabine with 24-hour continuous infusion of 5 FU for 2 of 3 weeks. Chemoradiation (CRT) consisted of RT of 50.4 Gy in 28 fractions or 50 Gy in 25 fractions and weekly oxaliplatin with 24-hour continuous infusion of 5 FU throughout RT. The first 7 patients also received celecoxib 200 mg BID throughout induction CT and CRT. Upon completion of CRT, surgical candidates underwent a pancreatoduodenectomy. Response rate was assessed according to RECIST criteria 4 weeks after the end of CRT. CTC AE v3 was used to grade the acute side effects. The failure-free survival (FFS), overall survival (OS) and median survival were analyzed by the Kaplan Meier method. Results: Twenty-nine patients who had borderline resectable pancreatic adenocarcinoma at the UNMC were enrolled and received induction CT. Twenty-four patients completed CRT. Nineteen patients had surgical exploration: 4 were unresectable, 6 had intra-abdominal metastases, and 9 had resection (seven had R0 resection, 2 had R1 resection, and 6 had negative nodes). The median follow up was 27 months. There were maximum 48% acute grade 3-4 toxicities during induction CT and CRT. The median FFS and OS were 7 and 10 months and the 2-year FFS and OS were 17% and 28%. Median OS and FFS for patients with and without resection was 26 vs. 9 months, p=0.06; and 19 vs. 5 months, p=0.01. Patients with CA19-9 above 90 U/L throughout treatment had significantly shorter FFS and OS than patients with CA19-9 less than 90 throughout treatment or had a decline from baseline to less than 90 after treatment. Conclusions: Induction gemcitabine/5-FU followed by 5-FU/oxaliplatin concurrent with RT led to down staging in 31% patients with subsequent resection. Further innovative strategies are needed to improve the outcome of patients with locally advanced pancreatic cancer. No significant financial relationships to disclose.

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