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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00238212 |
RATIONALE: 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.
PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with unresectable or metastatic gallbladder cancer or cholangiocarcinoma.
Condition | Intervention | Phase |
---|---|---|
Extrahepatic Bile Duct Cancer Gallbladder Cancer |
Drug: sorafenib tosylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of BAY 43-9006 (NSC #724772) as Single Agent in Unresectable or Metastatic Gallbladder Carcinoma and Cholangiocarcinoma |
Estimated Enrollment: | 50 |
Study Start Date: | October 2005 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within approximately 8.3 - 25 months.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed cholangiocarcinoma or gallbladder carcinoma
Histologic confirmation of adenocarcinoma of a metastatic site with clinical documentation of gallbladder or bile duct involvement allowed provided there is no evidence of another primary
Patients must have 1 of the following histologic types:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
None of the following significant uncontrolled cardiac diseases:
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent therapeutic anticoagulation
Study ID Numbers: | CDR0000444959, SWOG-S0514 |
Study First Received: | October 12, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00238212 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the gallbladder adenocarcinoma with squamous metaplasia of the gallbladder cholangiocarcinoma of the gallbladder squamous cell carcinoma of the gallbladder adenocarcinoma of the extrahepatic bile duct |
cholangiocarcinoma of the extrahepatic bile duct unresectable extrahepatic bile duct cancer recurrent extrahepatic bile duct cancer recurrent gallbladder cancer unresectable gallbladder cancer |
Gallbladder Diseases Cholangiocarcinoma Biliary Tract Neoplasms Digestive System Neoplasms Bile Duct Cancer, Extrahepatic Squamous Cell Carcinoma Protein Kinase Inhibitors Recurrence Carcinoma Gall Bladder Cancer Digestive System Diseases |
Bile Duct Diseases Metaplasia Biliary Tract Diseases Epidermoid Carcinoma Gastrointestinal Neoplasms Gallbladder Neoplasms Bile Duct Neoplasms Carcinoma, Squamous Cell Adenocarcinoma Sorafenib Neoplasms, Glandular and Epithelial |
Gallbladder Diseases Cholangiocarcinoma Neoplasms by Histologic Type Biliary Tract Neoplasms Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Digestive System Diseases Bile Duct Diseases Therapeutic Uses Biliary Tract Diseases Gallbladder Neoplasms Bile Duct Neoplasms Adenocarcinoma Sorafenib Neoplasms, Glandular and Epithelial |