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Sponsors and Collaborators: |
Brown University Rhode Island Hospital The Miriam Hospital Memorial Hospital of Rhode Island |
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Information provided by: | Brown University |
ClinicalTrials.gov Identifier: | NCT00447122 |
Phase II study of lapatinib and gemcitabine for patients with metastatic pancreatic cancer.
Condition | Intervention | Phase |
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Metastatic Pancreatic Cancer |
Drug: gemcitabine and Lapatinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | BrUOG-PA-209: Lapatinib and Gemcitabine for Metastatic Pancreatic Cancer: A Phase II Study #108181 |
Estimated Enrollment: | 125 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | March 2009 |
103 patients with advanced pancreatic cancer will receive gemcitabine 1 gm/m2/week for 3 weeks then 1 week off and lapatinib 1500 mg/day until progression.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Women of child bearing potential must be non pregnant and non lactating.The effects of lapatinib on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A female is eligible to enter and participate in the study if she is of:
Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who:
Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment.
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Active cardiac disease, defined as:
United States, Rhode Island | |
Lifespan Hospitals | |
Providence, Rhode Island, United States, 02903 |
Principal Investigator: | howard safran, MD | Brown University |
Study ID Numbers: | BrUOG-PA-209 |
Study First Received: | March 12, 2007 |
Last Updated: | July 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00447122 |
Health Authority: | United States: Food and Drug Administration |
Pancreatic Cancer |
Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases |
Gastrointestinal Neoplasms Lapatinib Endocrinopathy Gemcitabine Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Protein Kinase Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |