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SWOG Update
April 2010

Welcome to the April 2010 SWOG Update.

For all members and friends of the Southwest Oncology Group, the SWOG Update will keep you informed of what's happening with the Group. News to report? Send it to

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Study Updates  
S0941: TKIs against biliary cancers
bile ducts illustration Just launched, S0941 tests combined erlotinib and sorafenib on patients with unresectable or metastasized gallbladder carcinoma or cholangiocarcinoma. [more]
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Study Update

S0941: New study uses tyrosine kinase inhibitors against biliary cancers

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

diagram highlighting gall bladder, pancreas, and associated ducts
Credit: NCI
Cancer of the bile ducts or gallbladder is diagnosed in almost 10,000 new patients each year in the U.S., according to American Cancer Society figures.

For patients whose biliary cancer is unresectable or has metastasized, cytotoxic chemotherapy generally has limited effect, resulting in mean survival times of less than a year. Gemcitabine-based chemo is the one used most frequently, and the gemcitabine and cisplatin combination is one standard option, based on the results of a recent phase II study showing an overall survival of 11 months and progression-free survival of 8 months with this combination.

This modest success with chemotherapy has turned more recent research efforts toward better understanding the molecular origins of biliary cancers, leading to the identification of promising molecular targets for therapy, including vascular endothelial growth factor (VEGF) and epidermal growth factor receptor (EGFR).

In one recent study, more than half of 236 cases of cholangiocarcinoma showed overexpression of VEGF, and almost one quarter of the cases showed overexpression of EGFR. VEGF expression showed an association with metastasis, and EGFR expression an association with tumor progression.

The newly launched S0941 aims for both targets, combining a VEGF pathway inhibitor -- sorafenib -- with an EGFR inhibitor -- erlotinib. Therapies combining tyrosine kinase inhibitors to target both VEGF and EGFR pathways simultaneously have shown significant clinical activity in colon cancer and other tumor types.

"The cross-talk between the EGFR and VEGF pathways lends theoretical support to combining two agents that target these pathways," says study coordinator Anthony B. El-Khoueiry, M.D., of the University of Southern California's Norris Cancer Center. "This study builds on the previous SWOG S0514 study of sorafenib alone in cholangiocarcinoma as well as on a study of erlotinib alone in the same patient population."

S0941 patients will take 100 mg of oral erlotinib each day and 400 mg of oral sorafenib twice a day until their disease progresses or drug toxicity becomes unacceptable. They will be followed for up to three years.

The primary objective will be progression-free survival, with overall survival as a secondary objective in patients with advanced biliary cancers who have not had any prior therapy for metastatic or unresectable disease. The study also seeks to assess the response rate and the frequency and severity of toxicities.

Patients with a confirmed diagnosis of either gallbladder carcinoma or cholangiocarcinoma with disease that is unresectable or metastatic may be eligible. Disease should be measurable and confirmed cytologically or pathologically. Patients with ampullary carcinoma are not eligible. Patients must not have received any prior therapy for metastatic disease. The study accrual target is 50 patients. Please review the detailed eligibility criteria.

Eligible patients can find the nearest participating institution online or by contacting the Southwest Oncology Group at (210) 614-8808 or at

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