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This is an open-label, non-randomized, combination study of cetuximab, gemcitabine, 5-FU, and external beam radiotherapy in patients with locally advanced, non-metastatic pancreatic cancer.
All patients will be assessed by history and physical examination including weight, vital signs, and performance status within 14 days of initiation of therapy. Baseline hematologic and biochemical profiles, including CBC with differential, alkaline phosphatase, bilirubin, SGOT (AST), BUN, creatinine, and CA 19-9 will be completed within 14 days of initiation of therapy.
During cycle I (chemoradiation), gemcitabine (200 mg/m2) and cetuximab 400mg/m2 initial dose followed by 250mg/m2 IV weekly will be given with continuous infusion 5-FU (200 mg/m2/day) delivered 5 of every 7 days and concurrent external beam radiation therapy. Cetuximab, gemcitabine and 5-FU will begin on the first week of external beam radiotherapy and will continue throughout the course of external beam radiation therapy, and will be discontinued following the conclusion of external beam radiation therapy. All patients will have a central venous access device placed to facilitate chemotherapy administration.
During cycles 2 through 5 (chemotherapy), gemcitabine will be administered at a dose of 1000 mg/m2 over 30 minutes followed by cetuximab at a dose of 250mg/m2 over 30 minutes weekly for 3 weeks followed by one-week rest for four cycles.
Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Gemcitabine/Fluorouracil with External Beam Radiation
University of Massachusetts Medical School
University of Massachusetts, Worcester
Published on BioPortfolio: 2014-08-27T03:40:34-0400
Fluorouracil, External-Beam Radiation Therapy, and Gemcitabine With or Without Brachytherapy Using Phosphorus P32 in Treating Patients With Locally or Regionally Advanced Unresectable Adenocarcinoma of the Pancreas
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses hi...
The purpose of this study is determine the safety of bevacizumab, oxaliplatin, 5-FU, and gemcitabine in combination with external beam radiation therapy(Phase I portion) as well as to begi...
RATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help ...
The purpose of this study is to test a new treatment of pancreatic cancer that cannot be removed by surgery. This treatment is a Phase I dose escalation research study which will combine ...
The purpose of this study is to find out what effects, good and bad, the chemotherapy drugs gemcitabine (Gemzar) and paclitaxel (Taxol) have in combination with twice daily radiation trea...
Gemcitabine is the cornerstone of pancreatic cancer treatment. Although effective in most patients, development of tumor resistance to gemcitabine can critically limit its efficacy. The mechanisms res...
The objectives of this study were to assess the feasibility of preoperative gemcitabine/nab-paclitaxel-based chemoradiation therapy (CRT) for patients with borderline resectable pancreatic cancer (BRP...
Pancreatic cancer is one of the most lethal cancers with limited treatment options. Gemcitabine has been the standard drug for patients with advanced pancreatic cancer. Dasatinib is a competitive inhi...
Gemcitabine has been considered a first-line chemotherapy agent for the treatment of pancreatic cancer. However, the initial response rate of gemcitabine is low and chemoresistance occurs frequently. ...
Gemcitabine serves as a first-line chemotherapy agent for advanced pancreatic cancer. However, the molecular basis by which gemcitabine exerts its effects is not well-established, and the targeted gen...
A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.
An optical source that emits photons in a coherent beam. Light Amplification by Stimulated Emission of Radiation (LASER) is brought about using devices that transform light of varying frequencies into a single intense, nearly nondivergent beam of monochromatic radiation. Lasers operate in the infrared, visible, ultraviolet, or X-ray regions of the spectrum.
Computed tomography modalities which use a cone or pyramid-shaped beam of radiation.
The use of pre-treatment imaging modalities to position the patient, delineate the target, and align the beam of radiation to achieve optimal accuracy and reduce radiation damage to surrounding non-target tissues.
Timing the acquisition of imaging data to specific points in the breathing cycle to minimize image blurring and other motion artifacts. The images are used diagnostically and also interventionally to coordinate radiation treatment beam on/off cycles to protect healthy tissues when they move into the beam field during different times in the breathing cycle.
Pancreatitis Acute pancreatitis is inflammation of the pancreas caused by the release of activated pancreatic enzymes. Common triggers are biliary tract disease and chronic heavy alcohol intake. Diagnosis is based on clinical presentation...
Head and neck cancers
Cancer can occur in any of the tissues or organs in the head and neck. There are over 30 different places that cancer can develop in the head and neck area. Mouth cancers (oral cancers) - Mouth cancer can develop on the lip, the tongue, the floor...
Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...