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Sponsored by: |
Institut Paoli-Calmettes |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00541021 |
RATIONALE: Drugs used in chemotherapy such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving gemcitabine together with sorafenib is more effective than giving gemcitabine alone in treating pancreatic cancer.
PURPOSE: This randomized phase III trial is studying giving gemcitabine together with sorafenib to see how well it works compared with giving gemcitabine alone in treating patients with locally advanced or metastatic pancreatic cancer.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: gemcitabine hydrochloride Drug: sorafenib tosylate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | Phase III Randomized, Double-Blind Study Comparing Gemcitabine and Sorafenib or a Placebo in Patients With Locally Advanced or Metastatic Cancer of the Pancreas. |
Estimated Enrollment: | 104 |
Study Start Date: | December 2006 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
After completing 3 courses of therapy, patients in both arms who have stable or responding disease may continue to receive sorafenib tosylate or placebo in the absence of disease progression or unacceptable toxicity.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Diagnosis of adenocarcinoma of the pancreas
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Other severe illness, including any of the following:
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Exclusion criteria:
France | |
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes | Recruiting |
Marseille, France, 13273 | |
Contact: Frederic Viret, MD 33-4-91-22-35-37 viretf@marseille.fnclcc.fr |
Investigator: | Frederic Viret, MD | Institut Paoli-Calmettes |
Study ID Numbers: | CDR0000564099, IPC-BAYPAN, INCA-RECF0426, IPC-2005-006 |
Study First Received: | October 5, 2007 |
Last Updated: | July 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00541021 History of Changes |
Health Authority: | Unspecified |
stage III pancreatic cancer stage IV pancreatic cancer adenocarcinoma of the pancreas recurrent pancreatic cancer |
Antimetabolites Anti-Infective Agents Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Endocrine System Diseases Protein Kinase Inhibitors Immunosuppressive Agents Antiviral Agents Pancrelipase Recurrence |
Digestive System Diseases Radiation-Sensitizing Agents Neoplasm Metastasis Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Gemcitabine Sorafenib Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Digestive System Neoplasms Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Endocrine System Diseases Enzyme Inhibitors Protein Kinase Inhibitors |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Radiation-Sensitizing Agents Therapeutic Uses Pancreatic Diseases Gemcitabine Sorafenib Endocrine Gland Neoplasms |