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ISIS 2503 in Treating Patients With Advanced Cancer of the Pancreas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00005594
Recruitment Status : Completed
First Posted : May 3, 2004
Last Update Posted : January 4, 2011
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: ISIS 2503 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of ISIS 2503, an Antisense Inhibitor of H-Ras, in Patients With Advanced Pancreatic Cancer
Study Start Date : July 2000
Primary Completion Date : December 2000

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 each treatment cycle.
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.

Outcome Measures

Primary Outcome Measures :
  1. 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. [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Determine the duration of response in responding patients. Further characterize the safety profile of ISIS 2503 at the recommended dose and schedule. [ Time Frame: 24 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically confirmed advanced adenocarcinoma of the pancreas that is considered inoperable Measurable disease with at least 1 lesion measuring at least 2 cm in widest diameter identifiable on CT or MRI scan

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 6 months after study No underlying disease state associated with active bleeding No active infection requiring therapy No other prior malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy for pancreatic cancer Chemotherapy: No prior chemotherapy for pancreatic cancer except for fluorouracil and/or gemcitabine administered as a radiosensitizer No other concurrent chemotherapy for pancreatic cancer Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed provided indicator lesions not within prior radiation port Recovered from toxicity No concurrent radiotherapy for pancreatic cancer Surgery: See Disease Characteristics Other: No concurrent anticoagulation therapy with heparin No other concurrent approved or experimental cancer therapy

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005594

United States, Alabama
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
University of Alabama at Birmingham
National Cancer Institute (NCI)
Ionis Pharmaceuticals, Inc.
Study Chair: James A. Posey, MD University of Alabama at Birmingham
More Information

Responsible Party: James Posey, MD/ Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00005594     History of Changes
Other Study ID Numbers: CDR0000067701
UAB-9915 ( Other Grant/Funding Number: 0001215 )
First Posted: May 3, 2004    Key Record Dates
Last Update Posted: January 4, 2011
Last Verified: December 2010

Keywords provided by University of Alabama at Birmingham:
stage III pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases