Gemcitabine and ISIS-2503 for Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma: A North Central Cancer Treatment Group Phase II Trial
Year: 2004
Type: article
Study design: Clinical Trial
Abstract: PURPOSE: Gemcitabine remains the standard therapy for metastatic pancreatic adenocarcinoma (ACA), but has limited activity. ISIS-2503 is an antisense compound directed against H-ras with preclinical activity against pancreatic ACA in tumor models. The combination of ISIS-2503 and gemcitabine has been evaluated in a prior phase I study. METHODS: Patients with metastatic or locally advanced pancreatic ACA not amenable to surgery or local radiation received gemcitabine 1,000 mg/m(2) intravenously over 30 minutes on days 1 and 8 and ISIS-2503 6 mg/kg/d as a continuous intravenous infusion over 14 days of an every-3-weeks cycle. Responses were monitored by radiologic imaging every 6 weeks. RESULTS: Forty-eight eligible patients were enrolled, 43 with metastatic disease. Median follow-up was 12.6 months (range, 2.2 to 16.8 months) for living patients. A median of four cycles of treatment was given (range, 1 to 18 cycles). All patients were assessable for response and toxicity. The 6-month survival percentage was 57.5% (95% CI, 44.9% to 73.5%) and the median survival was 6.6 months. The response rate was 10.4% (one complete response, four partial responses). Clinically significant toxicity was limited except for one fatal pulmonary embolism. CONCLUSION: This study shows a promising response rate to the combination of gemcitabine and ISIS-2503 in patients with pancreatic ACA. The observed 6-month survival rate in these patients met our protocol-defined criteria for success. This regimen is tolerable, but is of unclear benefit. Additional studies evaluating the role of gemcitabine and ISIS-2503 in the treatment of pancreatic ACA should be considered.
Source: Journal of Clinical Oncology
Institutions: Geisinger Medical Center, Mayo Clinic
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Awards: G1094409381, G1539327064, G179864828, Sanford Community Cancer Consortium, G2082142344, G2383270398, G2440672419, G248987615, Geisinger Clinical Oncology Program, MICHIGAN CANCER RESEARCH CONSORTIUM CCOP, G358241105, G3789417232, ARIZONA MINORITY COMMUNITY CLINICAL ONCOLOGY PROGRAM, G42877212, TOLEDO COMMUNITY CLINICAL ONCOLOGY PROGRAM, G4735194841, Community Clinical Oncology Program, North Central Cancer Treatment Group, Cedar Rapids Oncology Project, Carle Cancer Center Community Clinical Oncology Program, Missouri Valley Cancer Consortium CCOP, G688707633, Sanford Community Cancer Consortium, G844520391, Iowa Oncology Research Association, Scottsdale Community Clinical Oncology Program, Mayo Clinic Comprehensive Cancer Center Support Grant, G937543590
OpenAlex ID: W2157202219