Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Phase 3 Completed Daiichi Sankyo

RandomizedOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if gemcitabine is more effective with or without exatecan mesylate in treating pancreatic cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine alone to that of gemcitabine and exatecan mesylate in treating patients who have locally advanced or metastatic pancreatic cancer.

Timeline

Start: 2001-07
Primary completion: 2005-04
Completion: 2005-04

Outcome

Missed primary endpoint

paper The median survival time was 6.7 months for exatecan plus gemcitabine and 6.2 months for gemcitabine alone (P = .52). PMID 16983112 ↗

paper Exatecan plus gemcitabine was not superior to gemcitabine alone with respect to overall survival PMID 16983112 ↗

Publications

Results Abou-Alfa GK, Letourneau R, Harker G, Modiano M, Hurwitz H, Tchekmedyian NS, Feit K, Ackerman J, De Jager RL, Eckhardt SG, O'Reilly EM. Randomized phase III study of exatecan and gemcitabine compared with gemcitabine alone in untreated advanced pancreatic cancer. J Clin Oncol. 2006 Sep 20;24(27):4441-7. doi: 10.1200/JCO.2006.07.0201.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Subject	exatecan	Small molecule	2 mg/m2	Intravenous