Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	NCCTG-N0043 NCT00006467, N0043

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.

Entry 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

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

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

Expected Enrollment

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

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.

Alberts SR, Schroeder M, Erlichman C, et al.: Gemcitabine and ISIS-2503 for patients with locally advanced or metastatic pancreatic adenocarcinoma: a North Central Cancer Treatment Group phase II trial. J Clin Oncol 22 (24): 4944-50, 2004.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Steven Alberts, MD, Protocol chair		Ph: 507-284-2511

Registry Information
Official Title		Phase II Trial of Gemcitabine and ISIS 2503 in Patients with Locally Advanced or Metastatic Pancreatic Adenocarcinoma
Trial Start Date		2001-02-16
Registered in ClinicalTrials.gov		NCT00006467
Date Submitted to PDQ		2000-09-11
Information Last Verified		2007-04-20
NCI Grant/Contract Number		CA25224

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