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Sponsored by: |
Grupo Gallego de Investigaciones Oncologicas |
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Information provided by: | Grupo Gallego de Investigaciones Oncologicas |
ClinicalTrials.gov Identifier: | NCT00873353 |
The purpose of this study is to determine efficacy of the treatment with erlotinib in combination with capecitabine in patients with advanced pancreatic cancer.
Condition | Intervention | Phase |
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Metastatic Adenocarcinoma of the Pancreas |
Drug: capecitabine + erlotinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Non-Randomized Multicenter Phase II Trial to Evaluate the Efficacy and Safety of Tarceva in Combination With Capecitabine in Patients With Advanced Pancreatic Cancer |
Estimated Enrollment: | 32 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | September 2010 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Unique arm: Experimental
6 cycles (3 weeks each one) of :
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Drug: capecitabine + erlotinib
6 cycles (3 weeks each one) of :
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This efficacy will be determined by objective response rate following RECIST criteria.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate bone marrow function as determined by:
Adequate liver function, as determined by:
Adequate renal function, as determined by:
Exclusion Criteria:
Non-controlled hypertension or cardiovascular disease clinically significant (active):
Spain, La Coruña | |
GGIO (Grupo Gallego de Investigaciones Oncológicas) | Recruiting |
Santiago de Compostela, La Coruña, Spain, 15701 | |
Contact: Rafael López López, Coordinator rllopez@seom.org | |
Principal Investigator: José Carlos Méndez Méndez, MD | |
Principal Investigator: Margarita Reboredo López, MD | |
Principal Investigator: Juan de la Cámara Gómez, MD | |
Principal Investigator: José Ramón Mel Lorenzo, MD | |
Principal Investigator: Mercedes Salgado Fernández, MD | |
Principal Investigator: Mónica Jorge Fernández, MD | |
Principal Investigator: Rafael López, López | |
Principal Investigator: Carlos Grande Ventura, MD | |
Principal Investigator: Carlos Romero Reinoso, MD |
Study Chair: | Rafel López López, Coordinator | Grupo Gallego de Investigaciones Oncológicas |
Responsible Party: | Grupo Gallego de Investigaciones Oncologicas ( Rafael López López ) |
Study ID Numbers: | ML21154, 2007-003206-96 |
Study First Received: | March 31, 2009 |
Last Updated: | March 31, 2009 |
ClinicalTrials.gov Identifier: | NCT00873353 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
Metastatic Adenocarcinoma of the Pancreas |
Antimetabolites Erlotinib Capecitabine Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Protein Kinase Inhibitors Pancrelipase |
Carcinoma Digestive System Diseases Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Antimetabolites Erlotinib Capecitabine Antimetabolites, Antineoplastic Neoplasms by Histologic Type Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Endocrine System Diseases Enzyme Inhibitors |
Protein Kinase Inhibitors Pharmacologic Actions Carcinoma Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Pancreatic Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |