Trial Combination Irinotecan, Oxaliplatin and Cetuximab for Locally Advanced or Metastatic Pancreatic Cancer
Summary
The purpose of this Phase II study is to determine how safe and effective treatment using the combination of chemotherapy drugs irinotecan, oxaliplatin and cetuximab is in controlling pancreatic cancer. Cetuximab (ERBITUXTM) has been approved by the FDA for the treatment of cancer of the head and neck, colon, or rectum. Oxaliplatin and irinotecan have both been FDA-approved for the treatment of colorectal cancer. However, this combination of drugs is considered experimental because this combination of the 3 drugs, oxaliplatin, irinotecan, or cetuximab, is not approved by the Food and Drug Administration (FDA) for the treatment of any type of cancer. However, use of this combination of drugs at the UNM CC has shown a significant effect on reducing tumor size in patients with locally advanced or metastatic pancreatic cancer.
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Pancreatic Cancer
Intervention
irinotecan, oxaliplatin and cetuximab
Location
Universtiy of New Mexico - Cancer Center
Albuquerque
New Mexico
United States
87131-0001
Status
Recruiting
Source
New Mexico Cancer Care Alliance
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00871169
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Pancreatic Neoplasms
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).
Pancreatic Stellate Cells
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.
Pancreatic Polypeptide
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.
Pancreatic Extracts
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.
Trypsin Inhibitor, Kazal Pancreatic
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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