Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gallbladder Cancer or Cholangiocarcinoma
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|ClinicalTrials.gov Identifier: NCT01093222|
Recruitment Status : Completed
First Posted : March 25, 2010
Results First Posted : January 29, 2014
Last Update Posted : June 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Erlotinib Hydrochloride Drug: Sorafenib Tosylate||Phase 2|
I. To assess the progression-free survival in patients with unresectable or metastatic gallbladder carcinoma or cholangiocarcinoma treated with the combination of sorafenib (sorafenib tosylate) and erlotinib (erlotinib hydrochloride).
II. To assess the overall survival in patients with unresectable or metastatic gallbladder carcinoma or cholangiocarcinoma treated with the combination of sorafenib and erlotinib.
III. To assess the objective response rate. IV. To assess the frequency and severity of toxicities. V. To collect specimens for banking for future research.
OUTLINE: This is a multicenter study.
Patients receive sorafenib tosylate orally (PO) twice daily and erlotinib hydrochloride PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up every 6 months for 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Sorafenib (NSC-724772) and Erlotinib (NSC-718781) in Patients With Advanced Gallbladder Carcinoma or Cholangiocarcinoma|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2014|
Experimental: Treatment (sorafenib tosylate and erlotinib hydrochloride)
Patients receive sorafenib tosylate PO twice daily and erlotinib hydrochloride PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Erlotinib Hydrochloride
Drug: Sorafenib Tosylate
- Progression-free Survival [ Time Frame: Up to 3 years ]From date of registration to date of first documentation of progression or symptomatic deterioration (as defined in protocol), or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.
- Overall Survival [ Time Frame: Up to 3 years ]From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
- Objective Response [ Time Frame: Up to 3 years ]Complete response (CR) is complete disappearance of all target and non-target lesions, no new lesions and no disease related symptoms. Partial response (PR) is a greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Confirmed response is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.
- Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug [ Time Frame: Up to 3 years ]Only adverse events that are possibly, probably or definitely related to study drug are reported.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093222
|Principal Investigator:||Anthony El-Khoueiry||Southwest Oncology Group|