At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 40 enrolled
Drug / intervention
Erlotinib Hydrochloride +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of Sorafenib (NSC-724772) and Erlotinib (NSC-718781) in Patients With Advanced Gallbladder Carcinoma or Cholangiocarcinoma
In Brief
A Phase 2 clinical trial evaluating Erlotinib Hydrochloride and Sorafenib Tosylate for Extrahepatic Bile Duct Adenocarcinoma and 8 related conditions. Completed, enrolled 40 participants across 141 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsExtrahepatic 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
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2010
Enrollment StartApr 2010
Primary CompletionSep 2012
Study CompletionSep 2014
TodayJul 2026
First PostedMar 25, 2010
Enrollment StartApr 1, 2010
Primary CompletionSep 1, 2012
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 16.3 years ago
Interventions
Erlotinib Hydrochloridedrug
Given PO
Sorafenib Tosylatedrug
Given PO