ISIS 2503 In Treating Patients With Advanced Cancer Of The Pancreas

Study Overview

ISIS 2503 in Treating Patients With Advanced Cancer of the Pancreas

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.

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.

Pancreatic Cancer

DRUG: ISIS 2503

CDR0000067701
UAB-9915 (OTHER_GRANT Identifier) (OTHER_GRANT: 0001215)
ISIS-2503-CS5
UAB-F990526011
NCI-G00-1730

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2000-05-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2010-12-30
First Submitted that Met QC Criteria 2004-04-30	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2011-01-04
First Posted (ESTIMATED) 2004-05-03	Results First Posted N/A	Last Verified 2010-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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 e	DRUG: ISIS 2503 Beginning dosage of ISIS 2503 is 6 mg/kg/day given as a continuous i.v. infusion over the first 14 days of a 21-day treatment cycle. This will be repeated for the first two weeks of every three-week treatment cycle.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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 e

DRUG: ISIS 2503

Beginning dosage of ISIS 2503 is 6 mg/kg/day given as a continuous i.v. infusion over the first 14 days of a 21-day treatment cycle. This will be repeated for the first two weeks of every three-week treatment cycle.

Primary Outcome Measures	Measure Description	Time Frame
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	Measure Description	Time Frame
Determine the duration of response in responding patients. Further characterize the safety profile of ISIS 2503 at the recommended dose and schedule.		24 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)
Ionis Pharmaceuticals, Inc.

Investigators

STUDY_CHAIR: James A. Posey, MD, University of Alabama at Birmingham

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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