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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	over 18	NCI	NCCTG-894352 MAYO-894352, NCCTG-89-43-52

Objectives

I.  Compare time to progression and survival of patients with advanced 
nonmeasurable adenocarcinoma of the pancreas randomly assigned to treatment 
with octreotide vs. fluorouracil vs. fluorouracil/leucovorin.

Entry Criteria

Disease Characteristics:

Primary pancreatic adenocarcinoma beyond hope of surgical cure
with cytologic or biopsy proof of locally unresectable,
residual, recurrent, or metastatic disease

  Ductal or undifferentiated adenocarcinoma consistent with a
  pancreatic primary required

  Islet cell, acinar cell, and cystadenocarcinomas specifically
  excluded

  Pancreatic primary reasonably established by surgical
  inspection, CT scan, or sonography

  Previously irradiated primary tumor must clearly show
  subsequent progression

Nonmeasurable disease or measurable abdominal/liver disease
less than 5 cm required, with the following considered
measurable:

  Palpable hepatomegaly at least 5 cm below the costal margin
  in the midclavicular line(s) or below the xyphoid process on
  quiet respiration

  Bidimensionally measurable lesions at least 1.0 cm in
  diameter on physical exam or chest x-ray, at least 3.0 cm on
  CT, MRI, or ultrasound, or at least 5.0 cm (primary lesions
  only) on radioisotopic scan

No CNS metastases

Ineligible for protocol NCCTG-924352 (Phase II evaluation of
continuous-infusion fluorouracil with leucovorin, mitomycin and
dipyridamole)

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy for pancreatic cancer other than
  fluorouracil as a radiosensitizer

Endocrine therapy:
  No prior octreotide therapy for pancreatic cancer

Radiotherapy:
  At least 4 weeks since prior radiotherapy to primary tumor
  No concurrent radiotherapy allowed

Surgery:
  At least 3 weeks since any major surgical procedure involving
  resection or bypass

  At least 2 weeks since exploration and biopsy

Patient Characteristics:

Age:
  18 and over

Performance status:
  ECOG 0 or 1

Hematopoietic:
  WBC at least 3,600
  Platelets at least 100,000

Hepatic:
  Not specified

Renal:
  Not specified

Other:
  No frequent vomiting or severe anorexia
  Daily oral intake at least 1,200 calories
  No clinically significant infection
  No active second malignancy except:
     Superficial nonmelanomatous skin cancer
     Carcinoma in situ of the cervix
  No senility, severe emotional instability, or lack of
     cooperation
  No pregnant or nursing women

Expected Enrollment

A maximum of 160 patients will be accrued over 3-4 years, exclusive of those 
patients accrued prior to 01/92.

Outline

Randomized study.  Assignment ratios to Arms I, II, and III are 2:1:1.  
Patients who progress on Arm I are randomized a second time on Arms II and III 
for further treatment.

Arm I (closed as of 5/3/94):  Somatostatin Analogue Therapy.  Octreotide, 
Sandostatin, SSTN, NSC-293562.

Arm II:  Single-Agent Chemotherapy with Drug Modulation.  Fluorouracil, 5-FU, 
NSC-19893; with Leucovorin calcium, Citrovorum Factor, CF, NSC-3590.

Arm III:  Single-Agent Chemotherapy.  5-FU.

Burch PA, Block M, Wieand HS, et al.: A phase III evaluation of octreotide (Sandostatin-R) (O) versus chemotherapy with 5-FU (F) or 5-FU/leucovorin (L) in advanced exocrine pancreatic cancer (PC): a NCCTG study. [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-488, 203, 1995.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Margaret Block, MD, FACP, Protocol chair		Ph: 402-393-3110 Email: mblock@onchemwest.com

Mayo Clinic Cancer Center

Patrick Burch, MD, Protocol chair		Ph: 507-284-2511 Email: burch.patrick@mayo.edu