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| Sponsor: | Mayo Clinic |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00033462 |
Purpose
RATIONALE: Biological therapies such as erlotinib may interfere with the growth of cancer cells and slow the growth of the tumor.
PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have unresectable liver, bile duct, or gallbladder cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer |
Drug: erlotinib hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Trial Of OSI-774 In Patients With Hepatocellular Or Biliary Carcinoma |
| Study Start Date: | March 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups according to cancer type (hepatocellular vs biliary).
Patients receive oral erlotinib once daily. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for up to 3 years.
PROJECTED ACCRUAL: A total of 78 patients (39 per group) will be accrued for this study within 13 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed hepatocellular or biliary carcinoma
Measurable disease
Indicator lesions must be outside of prior treatment area and edges of lesions must be clearly distinct
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Gastrointestinal:
Ophthalmic:
No known abnormalities of the cornea including, but not limited to, the following:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
No more than 1 prior systemic anticancer therapy
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Arizona | |
| Mayo Clinic Scottsdale | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, District of Columbia | |
| Howard University Hospital | |
| Washington, District of Columbia, United States, 20060-0001 | |
| United States, Florida | |
| Mayo Clinic | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Wisconsin | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792 | |
| Study Chair: | Philip A. Philip, MD, PhD, FRCP | Barbara Ann Karmanos Cancer Institute |
More Information
| Study ID Numbers: | CDR0000069285, MAYO-MC0152, NCI-5429 |
| Study First Received: | April 9, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00033462 History of Changes |
| Health Authority: | United States: Federal Government |
|
localized unresectable adult primary liver cancer advanced adult primary liver cancer recurrent adult primary liver cancer unresectable gallbladder cancer recurrent gallbladder cancer unresectable extrahepatic bile duct cancer |
recurrent extrahepatic bile duct cancer adult primary hepatocellular carcinoma cholangiocarcinoma of the gallbladder cholangiocarcinoma of the extrahepatic bile duct adult primary cholangiocellular carcinoma |
|
Gallbladder Diseases Erlotinib Liver Diseases Biliary Tract Neoplasms Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
Liver Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Bile Duct Diseases Biliary Tract Diseases Gallbladder Neoplasms Bile Duct Neoplasms |