Adjuvant chemotherapy

Gemcitabine
Gemcitabine (Gemzar)
1000 mg/m2 iv over 30 min qw x 3 weeks
Q4w x 6 cycles

Neuhaus P et al. CONKO-001: final results of the randomized, prospective, multicenter phase III trial of adjuvant chemotherapy with gemcitabine vs observation in patients with resected pancreatic cancer (PC). 2008 ASCO annual meeting. LBA4504 (link to the abstract).  

Oettle H et al. Adjuvant chemotherapy with gemcitabine vs observation in patients undergoing curative-intent resection of pancreatic cancer. JAMA 2007; 297:267 (link to the article). 

5-FU + LV
5-FU 425 mg/m2/d iv bolus d1-5
Leucovorin 20 mg/m2/d iv bolus d1-5
Q4w x 6 cycles

Neoptolemos, JP et al. A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer. N Engl J Med 2004; 350:1200 (link to the article).
 

Adjuvant chemoradiation

5-FU 500 mg/m2/d iv bolus d1-3 repeat once after 2 wks
Concurrent radiotherapy 2 Gy/d to 20 Gy repeat once after 2 wks

Neoptolemos, JP et al. A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer. N Engl J Med 2004; 350:1200 (link to the article).
 

Adjuvant chemotherapy and chemoradiation for pancreatic head cancer (back to top)

Before chemoradiation:
Gemcitabine (Gemzar) 1000 mg/m2 iv over 30 min qw x 3 weeks
Concurrent chemoradiaton starting 1-2 weeks after gemcitabine:
5-FU 250 mg/m2/d civi during radiation
Radiotherapy 1.8 Gy/d to a total of 50.4 Gy
3-5 weeks after chemoradiation:
Gemcitabine 1000 mg/m2 iv over 30 min qw x 3 weeks q4w x 3

Regine WF et al. Fluorouracil vs gemcitabine chemotherapy before and after fluorouracil-based chemoradiation following resection of pancreatic adenocarcinoma. JAMA 2008; 299:1019 (link to the article).
 

Chemoradiation for locally advanced unresectable cancer (back to top)

Gemcitabine + RT
Gemcitabine (Gemzar) 600 mg/m2 iv qw x 6
Concurrent radiotherapy 1.8 Gy/d x 28 fractions to a total of 50.4 Gy
4 weeks later
Consolidation gemcitabine 1000 mg/m2 iv qw x 3 every 4 weeks (1 cycle) for 5 cycles

Loehrer PJ et al. A randomized phase III study of gemcitabine in combination with radiation therapy versus gemcitabine alone in patients with localized, unresectable pancreatic cancer: E4201. 2008 ASCO annual meeting. Abstract 4506 (link to the abstract). 

5-FU + RT
5-FU 500 mg/m2/d iv bolus d1-3 and 29-31
Concurrent radiotherapy to 40 Gy
Beginning on day 71, 5-FU 500 mg/m2 iv bolus qw till disease progression

Moertel, CG et al: Therapy of locally unresectable pancreatic carcinoma: a randomized comparison of high dose (6000 rads) radiation alone, moderate dose radiation (4000 rads + 5-fluorouracil), and high dose radiation + 5-fluorouracil: The Gastrointestinal Tumor Study Group. Cancer 1981; 48:1705 (link to the article).

Capecitabine + RT
Capecitabine (Xeloda) 800 mg/m2 po bid 5 days/week
Concurrent radiotherapy to 50.4 Gy
Then Capecitabine (Xeloda) 1000 mg/m2 po bid x 14 days q3w till progression

Saif MW et al. Phase I study of capecitabine with concurrent radiotherapy for patients with locally advanced pancreatic cancer: expression analysis of genes related to outcome. J Clin Oncol 2005; 23:8679 (link to the article).
 

Chemotherapy for locally advanced unresectable cancer

5-FU + LV + Mitomycin + Dipyridamole
5-FU 200 mg/m2/d civi x 4 weeks q5w
Leucovorin 30 mg/m2 iv bolus qw x 4 weeks q5w
Mitomycin 10 mg/m2 (max 15 mg) iv bolus q6w x 4 doses
Dipyridamole 75 mg po tid during FU administration
Surgical resection if tumor becomes resectable

Isacoff WH et al. Phase II trial of infusional fluorouracil, leucovorin, mitomycin, and dipyridamole in locally advanced unresectable pancreatic adenocarcinoma: SWOG S9700. J Clin Oncol 2007; 25:1665 (link to the article).
 

Chemotherapy for stage IV (metastatic) cancer (back to top)

Gemcitabine
Gemcitabine (Gemzar) 1000 mg/m2 iv over 30 min qw x 7 wks, followed by 1 w break, then weekly x 3 wks every 4 wks.

Burris, HA 3rd et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol 1997; 15:2403 (link to the article).

Fixed-dose-rate Gemcitabine
Gemcitabine (Gemzar) 1500 mg/m2 iv over 150 min qw x 3 wks every 4 wks

Poplin E et al. Phase III trial of gemcitabine (30-minute infusion) versus gemcitabine (fixed-dose-rate infusion [FDR]) versus gemcitabine + oxaliplatin (GEMOX) in patients with advanced pancreatic cancer (E6201). 2006 ASCO annual meeting. Abstract LBA4004. (link to the article).

Gemcitabine + Erlotinib
Gemcitabine (Gemzar) 1000 mg/m2 iv qw x 7 wks, followed by 1 w break, then weekly x 3 wks every 4 wks.
Erlotinib (Tarceva) 100 mg po qd

Approved by FDA on 11/2/2005 

Moore MJ et al. Erlotinib plus gemcitabine compared to gemcitabine alone in patients with advanced pancreatic cancer. A phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 2007; 25:1960 (link to the article).

Gemcitabine + Oxaliplatin
Gemcitabine (Gemzar) 1000 mg/m2 iv over 100 min d1
Oxaliplatin (Eloxatin) 100 mg/m2 iv over 2 hrs d2
Q2w

Louvet, C et al. Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: results of a GERCOR and GISCAD phase III trial. J Clin Oncol 2005; 23:3509 (link to the article).

Poplin E et al. Phase III trial of gemcitabine (30-minute infusion) versus gemcitabine (fixed-dose-rate infusion [FDR]) versus gemcitabine + oxaliplatin (GEMOX) in patients with advanced pancreatic cancer (E6201). 2006 ASCO annual meeting. Abstract LBA4004. (link to the article).

Gemcitabine + Cisplatin
Gemcitabine (Gemzar) 1000 mg/m2 iv over 30 min d1 and 15
Cisplatin (CDDP) 50 mg/m2 iv over 1 hour d1 and 15
Q4w

Heinemann V et al. Randomized phase III trial of gemcitabine plus cisplatin compared with gemcitabine alone in advanced pancreatic cancer. J Clin Oncol 2006; 24:3946 (link to the article). 

Gemcitabine + Capecitabine
Regimen 1
Gemcitabine (Gemzar) 1000 mg/m2 iv over 30 min d1 and 8
Capecitabine (Xeloda) 650 mg/m2 po bid d1-14
Q3w

Bernhard J et al. Clinical benefit and quality of life in patients with advanced pancreatic cancer receiving gemcitabine plus capecitabine versus gemcitabine alone: a randomized multicenter phase III clinical trial-SAKK 44/00-CECOG/PAN.1.3.001. J Clin Oncol 2008; 26:3695 (link to the article). 

Herrmann R et al. Gemcitabine plus capecitabine compared with gemcitabine alone in advanced pancreatic cancer: a randomized, multicenter, phase III trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group. J Clin Oncol 2007; 25:2212 (link to the article).  

Regimen 2
Gemcitabine (Gemzar) 1000 mg/m2 iv qw for 3 wks every 4 wks
Capecitabine (Xeloda) 1660 mg/m2/d for 3 wks every 4 wks

Cunningham D et al. Phase III randomized comparison of gemcitabine (GEM) versus gemcitabine plus capecitabine (GEM-CAP) in patients with advanced pancreatic cancer. ECCO 13-the European Cancer Conference. Abstract PS11 (link to the article).

Capecitabine + Erlotinib
Capecitabine (Xeloda) 1000 mg/m2 po bid x 14 days q3w
Erlotinib (Tarceva) 150 mg po qd

Kulke MH et al. Capecitabine plus erlotinib in gemcitabine-refractory advanced pancreatic cancer. J Clin Oncol 2007; 25:4787 (link to the article). 

Oxaliplatin + 5-FU + Leucovorin (OFF)
5-FU 2000 mg/m2 iv over 24 hours d1, 8, 15, 22
Leucovorin (LV) 200 mg/m2 iv over 30 min d1, 8, 15, 22
Oxaliplatin 85 mg/m2 iv d8, 22
Q6w

Pelzer U et al. A randomized trial in patients with gemcitabine refractory pancreatic cancer. Final results of the CONKO 003 study. 2008 ASCO annual meeting. Abstract 4508 (link to the abstract).