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Active Clinical Trials: Gallbladder

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ProtocolTitle
S0941
(GI- Gallbladder)
Phase II Study of Sorafenib (NSC-724772) and Erlotinib (NSC-718781) in Patients with Advanced Gallbladder Carcinoma or Cholangiocarcinoma (1805)
  • Eligibility: click to view information

    DISEASE CHARACTERISTICS:

    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
    PATIENT CHARACTERISTICS:

    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
    PRIOR CONCURRENT THERAPY:

    See Disease Characteristics
    At least 6 months since 1 adjuvant or neoadjuvant regimen of chemotherapy, hormonal therapy, immunotherapy, radiotherapy (to < 25% of bone marrow only), or chemoradiotherapy prior to documented recurrence or metastatic disease
    No prior treatment with any anti-angiogenic 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
    No concurrent grapefruit or its juice


  • Consent Forms: S0941 Consent
SWOG-S0809
(GI- Gallbladder)
A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed by Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC). (1652)
  • Eligibility: click to view information

    DISEASE CHARACTERISTICS:
    Histopathologically confirmed extrahepatic cholangiocarcinoma of the gallbladder or bile duct, meeting at least 1 of the following criteria:
    Pathological T2-4 disease
    Pathological N1 disease
    Positive margins (any T or N )
    Must have undergone potentially curative radical resection with negative (R0) or microscopically positive (R1) margins within the past 56 days and recovered
    No distant metastatic disease as indicated by a CT scan or MRI of the chest, abdomen, and pelvis within the past 42 days

    Positive resected regional lymph nodes allowed
    No ampullary cancer
    PATIENT CHARACTERISTICS:

    Zubrod performance status 0-1
    ANC > 1,500/¼L
    Platelet count > 100,000/¼L
    Serum creatinine < 1.5 mg/dL
    Total bilirubin < 1.5 times upper limit of normal (ULN)
    SGOT or SGPT < 2.5 times ULN
    Not pregnant or nursing
    Fertile patients must use effective contraception
    Able to swallow enteral medications and no requirement for a feeding tube
    No intractable nausea or vomiting
    No gastrointestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, requirement for IV alimentation, prior surgical procedures affecting absorptions. or uncontrolled inflammatory GI disease (e.g., Crohn disease, ulcerative colitis)
    No uncontrolled intercurrent illness including but not limited to any of the following:

    Ongoing or active infection
    Symptomatic congestive heart failure
    Unstable angina pectoris
    Cardiac arrhythmia
    Myocardial infarction or cerebrovascular accident within the past 3 months
    Uncontrolled diarrhea
    Psychiatric illness or social situations that would limit compliance with study requirements
    PRIOR CONCURRENT THERAPY:

    See Disease Characteristics
    No prior chemotherapy or radiotherapy for this disease
    No prior upper abdominal radiotherapy


  • Consent Forms: S0809 Consent
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