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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	Pharmaceutical / Industry	SANDOZ-SMSM-304-E-00 NCI-V95-0798

Objectives

I.  Compare the overall survival of patients with unresectable stage II or 
stage III/IV pancreatic cancer treated with fluorouracil (5-FU) plus 
octreotide pamoate long-acting release formulation (SMS 201-995 pa LAR) vs. 
5-FU/placebo.

II.  Compare the progression-free survival and objective tumor response rates 
in these 2 treatment groups.

III.  Compare the clinical benefit and tolerability of these 2 treatments.

Entry Criteria

Disease Characteristics:

Pathologically, histologically, or cytologically confirmed adenocarcinoma of
the exocrine pancreas that is unresectable stage II or stage III/IV
  Confirmation waived if previous diagnosis available and unequivocal
  No unusual histologies, e.g.:
     Cystadenocarcinoma
     Islet cell carcinoma
     Pancreatic lymphoma

Measurable or evaluable disease
  Pleural effusion/ascites not considered measurable or evaluable

Prior/Concurrent Therapy:

No prior therapy for pancreatic cancer except surgery
  Recurrence following curative resection and adjuvant therapy discussed with
     Sponsor
  At least 7 days since any major surgery (3 days since laparoscopy)
  No waiting period for percutaneous biopsy/stenting or central line placement

At least 4 weeks since any investigational drug

No prior somatostatin analogue except low-dose octreotide given
perioperatively or as adjuvant treatment for fluorouracil-related diarrhea

Patient Characteristics:

Age:
  18 and over

Performance status:
  Karnofsky 50%-100%

Hematopoietic:
  WBC at least 3,500
  ANC at least 1,500
  Platelets (untransfused) at least 100,000
  Hemoglobin (untransfused) at least 8.5 g/dL (5.3 mmoles/L)

Hepatic:
  Bilirubin no greater than 3.0 times normal
  AST/ALT no greater than 5 times normal
  PT/PTT no greater than 1.5 times normal
  No hepatic dysfunction
  No coagulation disorder except correctable vitamin K deficiency

Renal:
  Creatinine no greater than 1.95 mg/dL (177 micromoles/L)
  BUN (after hydration) no greater than 35 mg/dL (126 millimoles/L)
  No renal dysfunction

Cardiovascular:
  No congestive heart failure
  No myocardial infarction within 4 months
  No uncontrolled hypertension
  No arrhythmia
  No unstable angina pectoris

Pulmonary:
  No pulmonary dysfunction

Other:
  No hemorrhagic disorder
  No unstable diabetes
  No paraneoplastic syndrome
  No untreated hyperthyroidism
  No immunologic disorder
  No prior treatment with therapeutic doses of anticoagulants
  No requirement for medication that precludes safety and efficacy evaluations
  No second malignancy except:
     In situ or Stage I cervical cancer
     Nonmelanomatous skin cancer
     (Malignancy not recurring for 5 years discussed with Sponsor)
  Estrogen replacement allowed for postmenopausal women
  No pregnant or nursing women
     Negative pregnancy test required of fertile women
  Effective contraception required of fertile women

Expected Enrollment

412 patients will be accrued to obtain 330 evaluable patients.  The study may 
close early if interim analysis shows a significant difference in survival 
between the 2 regimens.

Outline

Randomized, double-blind study.  The following acronyms are used:
  5-FU                 Fluorouracil, NSC-19893
  PLCB                 Placebo
  SMS 201-995 pa LAR   Octreotide Pamoate Long-Acting Release formulation

Arm I:  Single-Agent Chemotherapy plus Somatostatin Analogue Therapy.  5-FU; 
plus SMS 201-995 pa LAR.

Arm II:  Single-Agent Chemotherapy.  5-FU; plus PLCB.

Trial Contact Information

Trial Lead Organizations

Novartis Pharmaceuticals Corporation

Andrea C.M. Kay, MD, Protocol chair		Ph: 973-503-6793