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 Completed 21 and over Pharmaceutical / Industry ALFACELL-P30-300 NCI-V95-0752

Objectives

I.  Compare the response rate, time to response, and duration of response in 
patients with stage III/IV measurable or evaluable pancreatic cancer who have 
failed prior gemcitabine treated with weekly intravenous P-30 protein plus 
daily oral tamoxifen vs. weekly intravenous fluorouracil.

II.  Compare the safety of these two treatments in patients who have failed 
gemcitabine.

III.  Compare progression-free and overall survival and quality of life in 
these patients.

Entry Criteria

Disease Characteristics:

Histologically confirmed adenocarcinoma of the pancreas in patients who have
failed gemcitabine

Stage III/IV disease
  Failed prior gemcitabine
  No CNS metastases

Measurable or evaluable disease exclusive of elevated tumor markers

Prior/Concurrent Therapy:

See Disease Characteristics
Prior radiotherapy with or without 5-FU 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
  PT, PTT, and fibrinogen normal

Hepatic:
  Bilirubin no greater than 2 times normal
  AST no greater than 2 times 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 abnormalities, 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 stability that precludes patient cooperation
  No pregnant or nursing women
  Effective contraception required of fertile patients

Expected Enrollment

A total of 150 patients will be entered over 12 months to obtain 120 evaluable 
patients for this multicenter study.

Outline

Randomized study.

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

Group II:  Single-Agent Chemotherapy.  Fluorouracil, 5-FU, NSC-19893.

Trial Contact Information

Trial Lead Organizations

Alfacell Corporation

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