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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Closed	no age specified		FCCC-85719 NCI-V85-0077

Objectives

I.  Determine the response rate for the combination of monoclonal antibody 
17-1A (MoAb 17-1A) and FAM chemotherapy 
(5-fluorouracil/adriamycin/mitomycin-C) in patients with advanced pancreatic 
carcinoma.
II.  Determine whether there are any differences in response rate and survival 
when monoclonal antibody is given after FAM as opposed to before FAM.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with primary pancreatic 
adenocarcinoma histologically proven by surgical or fine needle biopsy under 
ultrasound or CAT scan guidance; disease must be beyond hope of surgical cure, 
and the presence of distant metastasis must be documented by liver scan, CAT 
scan, or chest x-ray.  Previous chemotherapy is not allowed, nor is previous 
radiotherapy to measurable or evaluable lesions.  At least 3 weeks should have 
elapsed since any surgical procedure involving bypass of the biliary tree or 
stomach, and 2 weeks should have passed since exploration and biopsy only.  An 
ECOG performance status of 0-2 (or Karnofsky greater than 50%) is required, as 
are WBC and platelet counts of more than 4,000 and 150,000/cumm, respectively. 
 There may be no evidence of renal disease with elevation of blood urea more 
than 30 mg% or creatinine greater than 1.5 mg%.  Patients with impaired liver 
function with a bilirubin greater than 2 mg% are not eligible unless the 
elevation is due to obstructive jaundice from compression of the common bile 
duct and a biliary drainage procedure prior to treatment is not possible; a 
serum bilirubin greater than 4 mg% excludes in any case.  Patients should have 
no history of severe allergies to mouse protein, no evidence of an active 
infectious process, and an estimated food intake greater than 1,500 
calories/day with no evidence of malnutrition.  Active heart disease (i.e., 
myocardial infarction within the past 3 months, symptomatic cardiac 
insufficiency, heart block greater than first degree, or history of congestive 
heart failure at any time) excludes.

Expected Enrollment

60 patients (30/arm) will be entered.

Outline

Randomized study.
Arm I:  Single-agent Immunotherapy Followed by 3-Drug Combination 
Chemotherapy.  Monoclonal Antibody 17-1A, MoAb 17-1A; followed by FAM:  
5-Fluorouracil, 5-FU, NSC-19893; Adriamycin, ADR, NSC-123127; Mitomycin-C, 
MITO-C, NSC-26980.
Arm II:  3-Drug Combination Chemotherapy Followed by Single-agent 
Immunotherapy.  FAM; followed by MoAb 17-1A.

Trial Contact Information

Trial Lead Organizations

Fox Chase Cancer Center - Philadelphia

Anthony R. Paul, MD, Protocol chair(Contact information may not be current)		Ph: 215-728-6900; 888-369-2427