Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas

OBJECTIVES: I. Determine the 6-month and overall survival rates in patients with locally
advanced or metastatic adenocarcinoma of the pancreas treated with gemcitabine and ISIS
2503. II. Determine the response rate of these patients treated with this regimen. III.
Assess the toxicity of this regimen in this patient population.

OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes on
days 1 and 8 and ISIS 2503 IV continuously on days 1-14. Treatment continues every 21 days
in the absence of disease progression or unacceptable toxicity. Patients are followed every
3 months for 1 year and then every 6 months for 4 years.

DISEASE CHARACTERISTICS: Histologically confirmed locally advanced or metastatic
adenocarcinoma of the pancreas not amenable to standard curative therapy Duct cell
Undifferentiated The following cellular types are not eligible: Islet cell carcinoma
Acinar cell carcinoma Cystadenocarcinoma No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 No underlying disease associated with active bleeding Hepatic:
Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no
greater than 3 times ULN AST no greater than 3 times ULN PT and PTT normal Renal:
Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy
test Fertile patients must use effective contraception during and for 6 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy
or immunotherapy No concurrent immunotherapy No colony-stimulating factors during first
course of therapy Chemotherapy: No prior chemotherapy except radiosensitizing agents used
in adjuvant setting or in treatment of locally advanced disease No prior gemcitabine No
prior ISIS 2503 No other concurrent chemotherapy Endocrine therapy: Not specified
Radiotherapy: No prior radiotherapy to 25% or greater of bone marrow No concurrent
radiotherapy Surgery: Not specified