Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gallbladder Cancer or Cholangiocarcinoma

Completed · Phase 2

Conditions studied: Extrahepatic Bile Duct Adenocarcinoma, Gallbladder Adenocarcinoma, Gallbladder Adenocarcinoma With Squamous Metaplasia, Hilar Cholangiocarcinoma, Recurrent Extrahepatic Bile Duct Carcinoma, Recurrent Gallbladder Carcinoma, Undifferentiated Gallbladder Carcinoma, Unresectable Extrahepatic Bile Duct Carcinoma, Unresectable Gallbladder Carcinoma

In brief

This phase II trial is studying how well giving sorafenib tosylate together with erlotinib hydrochloride works in treating patients with locally advanced, unresectable, or metastatic gallbladder cancer or cholangiocarcinoma. Sorafenib tosylate and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.

Key facts

Study ID

NCT01093222

Run by

National Cancer Institute (NCI)

People needed

40

Starts

2010-04-01

Expected to finish

2014-09-01

Last updated by the study team

2015-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cytologically or pathologically confirmed gallbladder carcinoma or cholangiocarcinoma
• No ampullary carcinoma
• Locally advanced unresectable or distant metastatic disease
• Measurable disease
• Patients with biliary obstruction must have decompression of the biliary tree by ERCP and stenting or percutaneous drainage
• No prior systemic treatment for metastatic or unresectable locally advanced disease
• No known brain metastases
• Zubrod performance status of 0-1
• Leukocyte count ≥ 3,000/mm\^3
• ANC ≥ 1,000/mm\^3
• Platelet count ≥100,000/mm\^3
• Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
• For patient who had decompression of the biliary tree within the past 14 days, stability of the bilirubin level needs to be confirmed with two measurements within 5 to 7 days of each other
• Serum albumin ≥ 2.5 g/dL
• AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN for liver metastases)
• Creatinine clearance ≥ 60 mL/min
• Not pregnant or nursing
• Fertile patients must agree to use effective contraception
• No active biliary sepsis
• No bleeding diathesis
• No uncontrolled or clinically significant cardiovascular disease, including any of the following:
• Myocardial infarction within the past 6 months
• Uncontrolled angina within the past 6 months
• NYHA class II-IV congestive heart failure
• Grade 3 cardiac valve dysfunction

Where it is running

• Loma Linda University Medical Center — Loma Linda, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Fremont - Rideout Cancer Center — Marysville, California, United States
• Sutter Cancer Research Consortium — Novato, California, United States
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
• Valley Medical Oncology Consultants — Pleasanton, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• Poudre Valley Hospital — Fort Collins, Colorado, United States
• Saint Francis Hospital and Medical Center — Hartford, Connecticut, United States
• UF Cancer Center at Orlando Health — Orlando, Florida, United States
• Northeast Georgia Medical Center — Gainesville, Georgia, United States
• Memorial University Medical Center — Savannah, Georgia, United States
• Oncare Hawaii Inc-POB II — Honolulu, Hawaii, United States
• Queen's Medical Center — Honolulu, Hawaii, United States
• Straub Clinic and Hospital — Honolulu, Hawaii, United States
• University of Hawaii Cancer Center — Honolulu, Hawaii, United States
• Oncare Hawaii Inc-Kuakini — Honolulu, Hawaii, United States
• The Cancer Center of Hawaii-Liliha — Honolulu, Hawaii, United States
• Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States
• Maui Memorial Medical Center — Wailuku, Hawaii, United States
• Pali Momi Medical Center — ‘Aiea, Hawaii, United States
• Central Illinois CCOP — Decatur, Illinois, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• The University of Arizona Medical Center-University Campus — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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