Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas

Phase 2 Completed 48 enrolled Alliance for Clinical Trials in Oncology National Cancer Institute (NCI) · collab

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with ISIS 2503 in treating patients who have advanced or metastatic cancer of the pancreas.

Timeline

Start: 2001-02
Primary completion: 2004-01
Completion: 2004-01

Outcome

Met primary endpoint

paper The observed 6-month survival rate in these patients met our protocol-defined criteria for success. PMID 15611509 ↗

release “ISIS 2503 in combination with gemcitabine, clinical investigators observed six months or longer survival in patients with pancreatic cancer, surpassing the primary endpoint” ionis.com ↗

Publications

Results Alberts SR, Schroeder M, Erlichman C, Steen PD, Foster NR, Moore DF Jr, Rowland KM Jr, Nair S, Tschetter LK, Fitch TR. Gemcitabine and ISIS-2503 for patients with locally advanced or metastatic pancreatic adenocarcinoma: a North Central Cancer Treatment Group phase II trial. J Clin Oncol. 2004 Dec 15;22(24):4944-50. doi: 10.1200/JCO.2004.05.034.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Subject	ISIS 2503	Antisense oligonucleotide	6 mg/kg	Intravenous