S0514 Sorafenib in Treating Patients With Unresectable or Metastatic Gallbladder Cancer or Cholangiocarcinoma

Completed · Phase 2

Conditions studied: Adenocarcinoma of the Extrahepatic Bile Duct, Adenocarcinoma of the Gallbladder, Adenocarcinoma With Squamous Metaplasia of the Gallbladder, Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma of the Gallbladder, Recurrent Extrahepatic Bile Duct Cancer, Recurrent Gallbladder Cancer, Squamous Cell Carcinoma of the Gallbladder, Unresectable Extrahepatic Bile Duct Cancer, Unresectable Gallbladder Cancer

In brief

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

Key facts

Study ID

NCT00238212

Run by

National Cancer Institute (NCI)

People needed

50

Starts

2005-10-01

Last updated by the study team

2013-01-14

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have a cytologically or pathologically confirmed diagnosis of cholangiocarcinoma or gallbladder carcinoma
• The pathologic confirmation of gallbladder or cholangiocarcinoma may be made from the primary or metastatic site; biopsy of the gallbladder or bile duct mass is not necessary; patients with pathologic confirmation of adenocarcinoma of a metastatic site, along with clinical documentation of gallbladder or bile duct involvement and no evidence of another primary are also eligible; if clinical documentation of gallbladder or bile duct involvement is not possible because of removal of the organ, a clinically and/or radiographically consistent picture plus pathologic findings from the metastatic site that are determined to be consistent with cholangiocarcinoma are acceptable
• Eligible pathologic type: Patient must have one of the following subtypes: adenocarcinoma NOS, papillary carcinoma, adenocarcinoma, intestinal type, clear cell adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, squamous cell carcinoma, adenosquamous carcinoma, small cell carcinoma, undifferentiated carcinoma, carcinoma NOS; patient must not have carcinoid tumors or sarcomas
• Patient must have locally advanced or distant metastatic disease that is not surgically curable
• Patient must have measurable disease; x-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; x-rays, scans or other tests for assessment of non-measurable disease must have been performed within 42 days prior to registration; all disease must be assessed
• Institutions are required to submit paraffin-embedded specimens
• Institutions are required to seek additional patient consent for submission of blood
• Patient may have had prior surgery, including surgery for their gallbladder or cholangiocarcinoma; patients must be at least 14 days beyond any major surgery, and recovered from all effects of surgery
• Patient must not have received prior therapy for unresectable or metastatic disease; patient may have received prior chemotherapy, hormonal therapy, immunotherapy, radiation therapy (to less than 25% of bone marrow only) or chemoradiotherapy as neoadjuvant or adjuvant treatment; this must have been completed at least 12 months prior to documented recurrence or metastatic disease; patient must have recovered from all radiation induced toxicities
• Prior radiation therapy to metastatic sites, such as bone, is allowed as long as the patient has measurable lesion(s) that were not treated with radiation therapy; at least 28 days must have elapsed since completion of radiation therapy, and patient must have recovered from all effects
• Patient must not have received prior BAY 43-9006 or any inhibitor of VEGFR or the MAPK pathway
• Patient must have Zubrod performance status of 0-1
• Total serum bilirubin =< 3 x the institutional upper limit of normal (IULN)
• Serum transaminase (SGOT or SGPT) =< 2.5 x IULN; if liver metastasis is present, SGOT or SGPT must be =< 5 x IULN
• Patients with biliary obstruction must have decompressions of the biliary tree by ERCP and stenting or percutaneous drainage
• Serum creatinine =< 1.5 x IULN OR measured creatinine clearance >= 60 mL/min OR estimated creatinine clearance >= 60 mL/min
• Leukocyte count >= 3,000/mcL
• ANC >= 1,000/mcL
• Platelets >= 100,000/mcL
• PT, INR and PTT =< IULN
• Patients must not be taking the cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine, and Phenobarbital), rifampin, or St. Johns Wort
• Patient must not be on therapeutic anticoagulation; prophylactic anticoagulation (i.e., low dose warfarin) of venous or arterial access devices is allowed provided that the requirements for PT, INR and PTT are met
• Patient must not have any evidence of bleeding diathesis
• Patients must not have clinically significant cardiac disease that is not well controlled by medication (e.g., congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction within 12 months prior to registration
• Patient must not have uncontrolled hypertension

Where it is running

• Southwest Oncology Group — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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