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

Alternate Title

Chemotherapy in Treating Patients With Stage III or Stage IV Pancreatic Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	21 and over	Pharmaceutical / Industry	ALFACELL-P30-303 NCI-V96-0938

Objectives

I.  Compare the efficacy of weekly intravenous P-30 protein plus daily oral 
tamoxifen vs. weekly intravenous gemcitabine in patients with stage III/IV, 
measurable or evaluable pancreatic cancer.

II.  Compare the safety of these two treatments.

III.  Compare survival, progression-free survival, and quality of life in 
patients on these two regimens.

Entry Criteria

Disease Characteristics:

Histologically confirmed adenocarcinoma of the pancreas

Stage III/IV disease with documented progression
  No CNS metastases

Measurable or evaluable disease
  Evaluable disease not eligible for response determination and defined as:
     Multiple lesions too numerous to measure
     Liver span in right mid-clavicular line

  The following alone may not be measurable nor evaluable:
     Ascites
     Elevated tumor markers

Prior/Concurrent Therapy:

Prior radiotherapy with or without fluorouracil allowed
Prior surgery allowed

Patient Characteristics:

Age:
  21 and over

Performance status:
  Karnofsky 60%-100%

Hematopoietic:
  WBC at least 3,500/mm3
  Absolute neutrophil count at least 1,500/mm3
  Platelet count at least 100,000/mm3

Hepatic:
  Bilirubin no greater than 1.5 mg/dL
  AST no greater than twice normal
  PT, PTT, and fibrinogen normal

Renal:
  Creatinine normal

Cardiovascular:
  No NYHA class II-IV status
  No congestive heart failure
  No angina pectoris
  No arrhythmia
  No uncontrolled hypertension

Metabolic:
  No uncontrolled diabetes mellitus, i.e.:
     Fasting blood glucose greater than 300 mg/dL
     Any degree of metabolic acidosis
  No other significant metabolic abnormality, e.g., in serum calcium,
     phosphate, or other electrolytes

Other:
  No uncontrolled, serious infection
  No uncontrolled psychiatric disorder
  No uncontrolled seizure disorder or other neurologic disease
  No senility or emotional instability that precludes patient cooperation
  No pregnant or nursing women
  Effective contraception required of fertile patients

Expected Enrollment

150 patients will be entered over 18 months to obtain 120 evaluable patients 
for this multicenter study.

Outline

Randomized study.

Group I:  Single-Agent Chemotherapy plus Antiestrogen Therapy.  P-30 Protein 
(Onconase); plus Tamoxifen, TMX, NSC-180973.

Group II:  Single-Agent Chemotherapy.  Gemcitabine, dFdC, NSC-613327.

Trial Contact Information

Trial Lead Organizations

Alfacell Corporation

Stanislaw Mikulski, MD, Protocol chair		Ph: 973-748-8082