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	Treatment or Intervention	Phase
stage IVA pancreatic cancer stage III pancreatic cancer stage IVB pancreatic cancer adenocarcinoma of the pancreas	Drug: ISIS 2503	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

Alabama
      University of Alabama Comprehensive Cancer Center, Birmingham,  Alabama,  35294,  United States
New Hampshire
      Norris Cotton Cancer Center, Lebanon,  New Hampshire,  03756,  United States

Study chairs or principal investigators

James Posey, III,  Study Chair,  UAB Comprehensive Cancer Center   

Study ID Numbers:  CDR0000067701; UAB-9915; NCI-G00-1730; ISIS-2503-CS5; UAB-F990526011
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  May 2, 2000
ClinicalTrials.gov Identifier:  NCT00005594
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08