ISIS 2503 in Treating Patients With Advanced Cancer of the Pancreas

Phase 2

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: ISIS 2503

• Registration Number: NCT00005594
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of ISIS 2503 in treating patients who have advanced cancer of the pancreas.

Detailed Description

OBJECTIVES: I. Determine the response rate and time to progression in patients with advanced adenocarcinoma of the pancreas who are treated with ISIS 2503. II. Determine the duration of response in these patients receiving this regimen. III. Characterize the safety profile of ISIS 2503 at the recommended phase II dose and schedule in these patients.

OUTLINE: Patients receive ISIS 2503 IV continuously for 14 days. Treatment continues every 21 days for a minimum of 3 courses in the absence of unacceptable toxicity or disease progression.

PROJECTED ACCRUAL: A total of 14-27 patients will be accrued for this study within 12 months.

Study Timeline

• Study First Submitted: 2000-05-02
• Study Start: 2000-07
• Primary Completion: 2000-12
• Study First Submitted QC: 2004-04-30
• Study First Posted: 2004-05-03
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-30
• Last Update Posted: 2011-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ISIS 2503	ISIS 2503	All patients will begin treatment at a dose of 6 mg/kg/day of ISIS 2503. ISIS 2503 at the assigned dose will be given as a continuous i.v. infusion over the first 14 days of a 21-day treatment cycle. No drug will be administered during the third week of each treatment cycle.

Primary Outcome Measures

Name	Time	Method
The primary outcome measure of this study is to estimate the response rate and observe the time to tumor progression of the patients treated on this study.	24 weeks

Secondary Outcome Measures

Name	Time	Method
Determine the duration of response in responding patients. Further characterize the safety profile of ISIS 2503 at the recommended dose and schedule.	24 weeks

Trial Locations

Locations (2)

University of Alabama Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

Norris Cotton Cancer Center; 🇺🇸 Lebanon, New Hampshire, United States