Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Georgetown University GlaxoSmithKline |
---|---|
Information provided by: | Georgetown University |
ClinicalTrials.gov Identifier: | NCT00881621 |
Patients are being asked to participate in this study who have locally advanced or metastatic pancreatic cancer (cancer of the pancreas that has spread to another part of the body) that has gotten worse after first-line chemotherapy.
The purpose of this study is to see if the drugs, Capecitabine and Lapatinib (two chemotherapy agents), prolong survival and improve quality of life as compared to supportive care alone.
Lapatinib in combination with a drug called capecitabine, has been approved by the Food and Drug Administration (FDA) for the treatment of metastatic breast cancer. It has not yet been approved to treat this type of cancer.
Both of these drugs are pills.
This research is being done because it is not known if the combination of Capecitabine and Lapatinib is better than supportive care alone for pancreatic cancer.
Condition | Intervention | Phase |
---|---|---|
Pancreas Cancer |
Drug: Lapatinib and Capecitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Study of Lapatinib and Capecitabine in 2nd Line Treatment of Locally Advanced/Metastatic Pancreatic Cancer |
Estimated Enrollment: | 51 |
Study Start Date: | August 2009 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Lapatinib and Capecitabine: Experimental
Treatment
|
Drug: Lapatinib and Capecitabine
Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles
|
This is an open-label single-arm Phase II trial for patients with metastatic pancreatic cancer who have failed first line Gemcitabine-based therapy. Patients will be treated with a combination of Capecitabine and Lapatinib, a dual tyrosine-kinase inhibitor of EGFR and HER-2.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lisa Ley, MSN | 202-687-6533 | leyl@georgetown.edu |
United States, District of Columbia | |
Georgetown University Medical Center | Recruiting |
Washington, District of Columbia, United States, 20007 | |
Contact: Lisa Ley, MSN 202-687-6533 leyl@georgetown.edu | |
Principal Investigator: Ruth He, MD PhD |
Principal Investigator: | Ruth He, MD, PhD | Georgetown University |
Responsible Party: | Georgetown University Medical Center ( Aiwu Ruth He, MD, PhD ) |
Study ID Numbers: | 011438, IND #103,981, 2008-437 |
Study First Received: | April 13, 2009 |
Last Updated: | August 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00881621 History of Changes |
Health Authority: | United States: Institutional Review Board |
Pancreas cancer lapatinib capecitabine |
Antimetabolites Capecitabine Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Lapatinib Pancrelipase |
Protein Kinase Inhibitors Digestive System Diseases Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Endocrine Gland Neoplasms |
Antimetabolites Capecitabine Digestive System Neoplasms Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Endocrine System Diseases Enzyme Inhibitors |
Lapatinib Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Pancreatic Diseases Endocrine Gland Neoplasms |