Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gallbladder Cancer or Cholangiocarcinoma
Condition: 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
MeSH terms: Carcinoma; Adenocarcinoma; Cholangiocarcinoma; Klatskin Tumor; Carcinoma, Ductal; Gallbladder Neoplasms; Bile Duct Neoplasms; Recurrence; Metaplasia
Intervention: Erlotinib Hydrochloride; Sorafenib Tosylate
Intervention description: Given PO; Given PO
Intervention MeSH terms: Erlotinib Hydrochloride; Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cytologically or pathologically confirmed gallbladder carcinoma or cholangiocarcinoma

               -  No ampullary carcinoma

          -  Locally advanced unresectable or distant metastatic disease

          -  Measurable disease

          -  Patients with biliary obstruction must have decompression of the biliary tree by ERCP
             and stenting or percutaneous drainage

          -  No prior systemic treatment for metastatic or unresectable locally advanced disease

          -  No known brain metastases

          -  Zubrod performance status of 0-1

          -  Leukocyte count ≥ 3,000/mm^3

          -  ANC ≥ 1,000/mm^3

          -  Platelet count ≥100,000/mm^3

          -  Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN)

               -  For patient who had decompression of the biliary tree within the past 14 days,
                  stability of the bilirubin level needs to be confirmed with two measurements
                  within 5 to 7 days of each other

          -  Serum albumin ≥ 2.5 g/dL

          -  AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN for liver metastases)

          -  Creatinine clearance ≥ 60 mL/min

          -  Not pregnant or nursing

          -  Fertile patients must agree to use effective contraception

          -  No active biliary sepsis

          -  No bleeding diathesis

          -  No uncontrolled or clinically significant cardiovascular disease, including any of the
             following:

               -  Myocardial infarction within the past 6 months

               -  Uncontrolled angina within the past 6 months

               -  NYHA class II-IV congestive heart failure

               -  Grade 3 cardiac valve dysfunction

               -  Cardiac arrhythmia not controlled by medication

               -  History of stroke or transient ischemic attack within the past 6 months

               -  History of arterial thrombotic event of any type in the past 6 months

          -  No uncontrolled hypertension, as evidenced by systolic BP ≥ 150 mm Hg or diastolic BP
             ≥ 100 mm Hg, within the past 28 days

          -  Must be able to swallow and tolerate oral medications

               -  No gastrointestinal tract disease or prior abdominal surgery that results in an
                  inability to absorb oral medication

          -  No other 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 patient is currently in complete remission, or any other cancer from which the
             patient has been disease-free within the past 3 years

          -  No concurrent grapefruit or its juice

          -  At least 6 months since 1 adjuvant or neoadjuvant regimen of chemotherapy, hormonal
             therapy, immunotherapy, radiotherapy (to < 25% of bone marrow only), or
             chemoradiotherapy before documented recurrence or metastatic disease

          -  No prior treatment with any antiangiogenic agent or any EGFR inhibitors for any reason

          -  Concurrent multiple anti-hypertensive medications allowed

          -  No plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy,
             immunotherapy, or any other therapy, including herbal or alternative medications for
             treatment of cancer