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Phase II Trial of Gemcitabine and ISIS 2503 in Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

Phase II Trial of Gemcitabine and ISIS 2503 in Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma


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.

PROJECTED ACCRUAL: A total of 20-44 patients will be accrued within 10-22 months.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Steven R. Alberts, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000068281

NCT ID:

NCT00006467

Start Date:

February 2001

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage III pancreatic cancer
  • recurrent pancreatic cancer
  • duct cell adenocarcinoma of the pancreas
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • Adenocarcinoma
  • Pancreatic Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CentraCare ClinicSaint Cloud, Minnesota  56303
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Medcenter One Health SystemBismarck, North Dakota  58501