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ISIS 2503 in Treating Patients With Advanced Cancer of the Pancreas

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ISIS 2503
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama Comprehensive Cancer Center
  • Norris Cotton Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ISIS 2503

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 2, 2000
Last Updated
December 30, 2010
Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI), Ionis Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00005594
Brief Title
ISIS 2503 in Treating Patients With Advanced Cancer of the Pancreas
Official Title
Phase II Trial of ISIS 2503, an Antisense Inhibitor of H-Ras, in Patients With Advanced Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
December 2000 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI), Ionis Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ISIS 2503
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ISIS 2503
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James A. Posey, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Norris Cotton Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

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ISIS 2503 in Treating Patients With Advanced Cancer of the Pancreas

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