Phase III evaluation of octreotide versus chemotherapy with 5-fluorouracilor 5-fluorouracil plus leucovorin in advanced exocrine pancreatic cancer: A north central cancer treatment group study

There continues to be a need for new systemic approaches for the treatment of advanced pancreatic cancer. The purpose of this study was to compare the antitumor activity of the somatostatin analogue octreotide to 5-fluorourac il chemotherapy in a Phase III setting. Eighty-four patients with an Easter n Cooperative Oncology Group performance status of 0 or 1 and limited tumor volume were randomized to receive octreotide 200 mu g three times daily or 5-fluorouracil with or without leucovorin. After the first 12 patients had been randomized to octreotide, we increased the dose in the remaining pati ents to 500 mu g three times daily. This change was based on early reports in other studies, suggesting that our original dose may not have been effec tive and that higher doses of octreotide were well tolerated. A planned int erim analysis performed after 84 patients were enrolled demonstrated inferi or time to progression and survival for the patients randomized to octreoti de. Further accrual to the octreotide arm of this protocol was therefore te rminated. Octreotide in doses of 200-500 mu g three times daily does not de lay progression or extend survival in patients with advanced pancreatic can cer compared with treatment with 5-fluorouracil with or without Leucovorin.