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Sponsors and Collaborators: |
Rigshospitalet, Denmark Morten Ladekarl, MD, DMSc.,Dept. of Oncology, Århus University Hospital, Denmark |
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Information provided by: | Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT00350753 |
Erlotinib and bevacizumab have shown activity individually, as single drugs, or in combination with chemotherapy in upper gastro-intestinal cancers, including esophageal and gastro-esophageal adenocarcinomas, gastric cancer and pancreatic cancer. Biomarkers indicating an important role of EGF and VEGF have been found in these tumors, and in cholangiocarcinomas as well. There is promise that combined treatment with erlotinib and bevacizumab is active and tolerable in a broad range of upper gastro-intestinal cancers, justifying an experimental phase II-study of patients with these diagnoses, refractory or intolerant to standard systemic therapy.
Condition | Intervention | Phase |
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Esophageal Cancer Gastric Cancer Pancreatic Cancer Cholangiocarcinoma Gallbladder Cancer |
Drug: Erlotinib Drug: Bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Erlotinib and Bevacizumab in Patients With Advanced Upper Gastrointestinal Carcinomas, Refractory or Intolerable to Standard Systemic Therapy |
Estimated Enrollment: | 126 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Primary Objective
Secondary Objective
Treatment:
Bevacizumab (AvastinÒ) will be given intravenously at 10 mg/kg every other week.
Erlotinib is given as an orally daily dose and most be taken at least one hour before or two hours after ingestion of food.
Ages Eligible for Study: | 18 Months and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Sufficient organ function, defined as:
Exclusion Criteria:
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment, anticipation of need for major surgical procedure during the curse of the study
o Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to treatment
Contact: Ulrik Lassen, MD, PH.D. | ulassen@rh.dk |
Denmark | |
Rigshospitalet | Recruiting |
Copenhagen, Denmark, 2100 | |
Contact: Ulrik Lassen, MD., PH.D. ulassen@rh.dk | |
Principal Investigator: Ulrik Lassen, MD., PH.D. | |
Århus Sygehus | Recruiting |
Århus, Denmark, 8000 C | |
Contact: Morten Ladekarl, Dr.MSci. | |
Principal Investigator: Morten Ladekarl, Dr.MSci. | |
Odense University Hospital | Recruiting |
Odense, Denmark, 5000 | |
Contact: Per Pfeiffer, MD., PH.D. | |
Principal Investigator: Per Pfeiffer, MD., PH.D |
Principal Investigator: | Ulrik Lassen, MD., PH.D. | Rigshospitalet, Dept. of Oncology |
Responsible Party: | Rigshospitalet ( Ulrik Lassen ) |
Study ID Numbers: | EB-UGI-01, 2006-001308-35 |
Study First Received: | July 10, 2006 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00350753 |
Health Authority: | Denmark: Danish Medicines Agency |
Esophageal cancer Gastric cancer Pancreatic cancer Cholangiocarcinoma |
Gallbladder Diseases Gastrointestinal Diseases Pancreatic Neoplasms Esophageal Neoplasms Bevacizumab Stomach Diseases Stomach Neoplasms Biliary Tract Diseases Esophageal neoplasm Endocrine Gland Neoplasms Erlotinib Cholangiocarcinoma Biliary Tract Neoplasms Digestive System Neoplasms |
Esophageal disorder Endocrine System Diseases Stomach cancer Carcinoma Gall bladder cancer Digestive System Diseases Head and Neck Neoplasms Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Esophageal Diseases Gallbladder Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Angiogenesis Inhibitors |
Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |