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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over MAOP-5292 NCI-V93-0219

Objectives

I.  Determine the objective response rate and duration of remission in 
patients with advanced, measurable pancreatic adenocarcinoma who are treated 
with a continuous infusion of somatuline.

II.  Determine the time to disease progression and survival in this patient 
population.

III.  Evaluate the effect of this treatment on quality of life.

IV.  Evaluate the toxicity of this treatment.

Entry Criteria

Disease Characteristics:

Histologically confirmed adenocarcinoma of the pancreas that is
not amenable to curative resection and not suitable for
combined-modality therapy of locally unresectable disease
  Patients suited to combined-modality therapy (i.e.,
  encompassable in a 250 sqcm radiation port and no distant
  metastases) who refuse chemoradiotherapy are eligible at the
  discretion of the protocol chairman

Bidimensionally measurable disease outside prior radiotherapy
port required:
  Bidimensionally measurable palpable lesion
  Lesion at least 5 cm in diameter on radionuclide liver scan
  Lesion at least 1.5 cm in diameter on CT or sonogram
  Pulmonary lesion at least 1.0 cm on x-ray
  Lytic bone lesion at least 2.0 cm in diameter

The following are not considered measurable:
  Ascites
  Pleural effusion
  Osteoblastic bone lesion (or evidence of disease on bone scan
     alone)
  Previously irradiated lesion
  Bone marrow involvement
  Brain metastases
  Malignant hepatomegaly on physical exam alone
  Tumor markers (e.g., CEA)
  Unidimensional lesion

Prior/Concurrent Therapy:

No concomitant investigational therapy

Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy
  No concurrent chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  At least 4 weeks since radiotherapy
  No concurrent radiotherapy

Surgery:
  Not specified

Patient Characteristics:

Age:
  18 and over

Performance status:
  Zubrod 0-2

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

Hepatic:
  Bilirubin no more than 2.0 mg/dl

Renal:
  Creatinine no more than 2.0 mg/dl

Other:
  No diabetes mellitus requiring treatment OR
     FBS reliably controlled to less than 200 mg/dl
  No concurrent infection
     Patient must be afebrile for at least 3 days prior to
     therapy unless fever is attributable to tumor
  No known HIV positivity
  No second malignancy within 5 years except:
     Nonmelanomatous skin cancer
     Curatively treated Stage I carcinoma of the cervix
  No pregnant or nursing women
  Adequate contraception required of fertile women

Expected Enrollment

55 evaluable patients will be studied.

Outline

Nonrandomized study.

Single-Agent Chemotherapy.  Somatuline.

Trial Contact Information

Trial Lead Organizations

Mid-Atlantic Oncology Program

Joseph Schulz, MD, Protocol chair		Ph: 757-873-9400