SWOG clinical trial number
S0941

Phase II Study of Sorafenib (NSC-724772) and Erlotinib (NSC-718781) in Patients with Advanced Gallbladder Carcinoma or Cholangiocarcinoma

Closed
Phase
II
Accrual
73%
Published
Abbreviated Title
Phase II Cholangiocarcinoma with Sorafenib + Erlotinib
Activated
04/15/2010
Closed
09/15/2011
Participants
NCORP, Members, Medical Oncologists, Affiliates

Research committees

Gastrointestinal Cancer

Treatment

Erlotinib BAY 43-9006

Eligibility Criteria Expand/Collapse

Cytologically or pathologically confirmed diagnosis of gallbladder carcinoma or cholangiocarcinoma. No ampullary carcinoma. Locally advanced unresectable disease or distant metastatic disease. Must seek additional consent for specimen submission. Measurable disease. Must not have received prior systemic treatment for metastatic or unresectable locally advanced disease. May have received at most one adjuvant or neoadjuvant regimen of prior chemo, hormonal tx, immunotherapy, RT, or chemoRT. This must have been completed at least 6 months prior to documented recurrence or metastatic disease. Must not have received prior tx with any anti-angiogenic agent or EGFR inhibitor. Must meet hepatic function criteria detailed in Section 5.8. Zubrod performance status 0-1. Pts with biliary obstruction must have decompression of the biliary tree by ERCP and stenting or percutaneous drainage prior to registration. Must not have evidence of active biliary sepsis or of bleeding diathesis. Must not have uncontrolled or clinically significant cardiovascular disease. Must not have uncontrolled hypertension. Must be able to swallow and tolerate oral meds. No known brain mets. Must have no plans to receive concurrent chemo, hormonal tx, RT, immunotherapy, or any other tx including herbal or alternative meds for treatment of cancer. Must not be pregnant or nursing. No prior malignancy except: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the pt is currently n complete remission, or any other cancer from which the pt has been disease free for 3 years. Within 7 days prior to reg: measured or calculated creatinine clearance >/= 60 mL/min. Within 14 days prior to reg: leukocytes >/= 3,000/mcL; ANC >/= 1,000/mcL; platelets >/= 100,000/mcL. Within 28 days prior to reg: assessments of measurable disease. Within 42 days prior to reg: assessments of non-measurable disease.

Publication Information Expand/Collapse

2014

SWOG S0941: A phase II study of sorafenib and erlotinib in patients with advanced gallbladder carcinoma or cholangiocarcinoma

AB El-Khoueiry;C Rankin;AB Siegel;S Iqbal;I-Yeh Gong;KC Micetich;O Kayaleh;H Lenz;CD Blanke British Journal of Cancer 110(4):882-887;

PMid: PMID24423918 | PMC number: PMC3929880

2012

SWOG 0941: A phase II study of Sorafenib and Erlotinib in patients (pts) with advanced gallbladder cancer or cholangiocarcinoma

A El-Khoueiry;C Rankin;S Iqbal;K Micetich;O Kayaleh;H Lenz;C Blanke J Clin Oncol 30 (suppl; abstr 4113); American Society of Clinical Oncology 2012 Annual Mtg (June 1-5, 2012, Chicago, IL), poster presenetation;

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Research Committee(s)
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Activated
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Phase
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