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BBR 3464 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Cannot be Treated With Surgery

2014-07-23 21:55:17 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of BBR 3464 in treating patients who have locally advanced or metastatic pancreatic cancer that cannot be treated with surgery.

Description

OBJECTIVES: I. Determine the overall survival of patients with inoperable locally advanced or metastatic adenocarcinoma of the pancreas treated with BBR 3464. II. Determine the response rate, duration of response, time to disease progression, and duration of stable disease in patients treated with this drug. III. Determine the incidence and severity of the toxic effects of this drug in these patients. IV. Determine the disease-related symptoms in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients receive BBR 3464 IV over 1 hour on day 1. Treatment repeats every 21 days for a minimum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 9 weeks.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Study Design

Primary Purpose: Treatment

Conditions

Pancreatic Cancer

Intervention

BBR 3464

Location

Arizona Oncology Associates
Tucson
Arizona
United States
85712-2254

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:55:17-0400

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Medical and Biotech [MESH] Definitions

Tumors or cancer of the PANCREAS. Depending on the types of ISLET CELLS present in the tumors, various hormones can be secreted: GLUCAGON from PANCREATIC ALPHA CELLS; INSULIN from PANCREATIC BETA CELLS; and SOMATOSTATIN from the SOMATOSTATIN-SECRETING CELLS. Most are malignant except the insulin-producing tumors (INSULINOMA).

Star-shaped, myofibroblast-like cells located in the periacinar, perivascular, and periductal regions of the EXOCRINE PANCREAS. They play a key role in the pathobiology of FIBROSIS; PANCREATITIS; and PANCREATIC CANCER.

A 36-amino acid pancreatic hormone that is secreted mainly by endocrine cells found at the periphery of the ISLETS OF LANGERHANS and adjacent to cells containing SOMATOSTATIN and GLUCAGON. Pancreatic polypeptide (PP), when administered peripherally, can suppress gastric secretion, gastric emptying, pancreatic enzyme secretion, and appetite. A lack of pancreatic polypeptide (PP) has been associated with OBESITY in rats and mice.

Extracts prepared from pancreatic tissue that may contain the pancreatic enzymes or other specific uncharacterized factors or proteins with specific activities. PANCREATIN is a specific extract containing digestive enzymes and used to treat pancreatic insufficiency.

A pancreatic trypsin inhibitor common to all mammals. It is secreted with the zymogens into the pancreatic juice. It is a protein composed of 56 amino acid residues and is different in amino acid composition and physiological activity from the Kunitz bovine pancreatic trypsin inhibitor (APROTININ).

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