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Sponsors and Collaborators: |
Oncoscience AG Marienhospital Herne, Abt. für Hämatologie und Onkologie, Herne, Germany Onkologische Ambulanz, Klinik für Allgemeine Innere Medizin, Kiel, Germany Gemeinschaftspraxis für Hämatologie und Onkologie, Köln, Germany Onkologisches Zentrum III, Medizinische Klinik, Mannheim, Germany Onkologische Gemeinschaftspraxis, Mülheim, Germany II. Medizinische Klinik u. Poliklinik, Klinikum rechts der Isar, München, Germany Hämatologisch-Onkologische Schwerpunktpraxis, Münster, Germany Praxis für Internistische Onkologie und Hämatologie, Recklinghausen, Germany |
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Information provided by: | Oncoscience AG |
ClinicalTrials.gov Identifier: | NCT00561990 |
CHEMOTHERAPY-NAIVE PATIENTS WITH LOCALLY ADVANCED OR METASTATIC PANCREATIC CANCER
Condition |
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Pancreatic Cancer, Advanced or Metastatic |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | A RANDOMIZED, MULTICENTER, PHASE IIB/IIIA STUDY OF GEMCITABINE AND THE MONOCLONAL ANTIBODY NIMOTUZUMAB (OSAG 101) VERSUS GEMCITABINE AND PLACEBO FOR THE TREATMENT OF CHEMOTHERAPY-NAIVE PATIENTS WITH LOCALLY ADVANCED OR METASTATIC PANCREATIC CANCER |
tissue samples
Estimated Enrollment: | 188 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | September 2010 |
Groups/Cohorts |
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Arm A
Gemcitabine plus nimotuzumab
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Arm B
Gemcitabine plus placebo
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Pancreatic cancer is responsible for 227.000 deaths per year, and is the eighth most common cause of death from cancer in both sexes combined, a position relatively high when compared to incidence (thirteenth position) because of the very poor prognosis (the M/I ratio is 98%) (Global Cancer Statistics, 2002). The incidence of pancreatic carcinoma has increased almost 300% since 1950 and now exceeds the incidence of stomach cancer and cancer of the rectum. Carcinoma of the exocrine pancreas is nearly always a fatal disease. The overall 5-year survival rate for the disease is 4.1%.
Locally advanced or metastatic pancreatic cancer is relatively unresponsive to chemotherapy. Gemcitabine therapy provides some benefit and modestly improves survival compared with fluorouracil, but median survival in patients with advanced disease remains less than 6 months (Burris et al, 1997). Cytotoxic drug combinations were not able to show survival advantage compared to Gemcitabine alone in numerous randomized phase III studies.
Altered expression or constitutive activation of the epidermal growth factor receptor (EGFR/HER1/erbB1) commonly occurs in both primary and metastatic pancreatic cancers and is often a critical factor in progressive growth and resistance to normal mechanisms of cell death. Epidermal growth factor receptor expression in pancreatic cancer has been correlated with tumor aggressiveness.
Clinical trials already suggest that EGF-R targeted therapy may improve the antitumor activity of chemotherapy for treatment of pancreatic carcinoma. Monoclonal antibodies specific to EGF-R can be combined safely and effectively with chemotherapy.
Nimotuzumab (OSAG101, hR3, Theraloc) is a humanized monoclonal antibody (mAb) that binds to the EGFR. In preclinical studies the antibody has shown potent antitumor activity. Based on phase I data, the recommended dose has been established at 200 mg weekly. A previous phase II study in children with high grade brain tumors showed activity of Nimotuzumab as a monotherapeutic agent, even in prognostic very unfavourable diffuse, intrinsic pontine glioma. No drug related side effects were reported.
Nimotuzumab (OSAG101, Theraloc) in combination with radiotherapy for treatment of locally advanced squamous cell carcinomas of the head and neck resulted in high rates of antitumor response, and was accompanied by a favourable safety profile. Nimotuzumab (OSAG101, Theraloc) has a high hepatic uptake level.
This randomized, placebo-controlled Phase IIb/IIIa study analyzes the efficacy and safety of Nimotuzumab in combination with Gemcitabine for the treatment of chemotherapy-naive patients with advanced unresectable or metastatic pancreatic carcinoma.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
primary care clinic
Inclusion Criteria:
A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study:
adequate organ function as defined by the following criteria:
Exclusion Criteria:
had treatment with any of the following within the specified time frame prior to study drug administration:
Other serious illness or medical condition(s) including, but not limited to, the following:
Contact: Dirk Strumberg, MD | +49-23234995252 | dirk.strumberg@marienhospital-herne.de |
Contact: Ferdinand Bach | +49-4103180880 | f.bach@oncoscience-ag.de |
Germany | |
Marienhospital Herne | Recruiting |
Herne, Germany, 44621 | |
Contact: Dirk Strumberg, MD +49-2323-4995252 dirk.strumberg@marienhospital-herne.de |
Principal Investigator: | Dirk Strumberg, MD | University Bochum |
Study ID Numbers: | OSAG101-PCS07 |
Study First Received: | November 20, 2007 |
Last Updated: | November 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00561990 |
Health Authority: | Germany: Paul-Ehrlich-Institut |
pancreatic cancer |
Antibodies, Monoclonal Antibodies Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases |
Pancreatic Diseases Gastrointestinal Neoplasms Endocrinopathy Gemcitabine Immunoglobulins Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site |