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Active Clinical Trials: Cancer of Unknown Primary (CUP)

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ProtocolTitle
NCCTG-N0871A Phase II Study of Carboplatin (CBDCA), Paclitaxel (TAXOL), and Everolimus (RAD001) in previously Untreated Patients with Measurable Disease with Cancer of Unknown Primary (CUP) (1750)
  • Eligibility: click to view information

    DISEASE CHARACTERISTICS:

    Histologically confirmed diagnosis of 1 of the following:

    Metastatic adenocarcinoma
    Poorly differentiated non-small cell carcinoma
    Poorly differentiated squamous cell carcinoma
    Patients with biopsy proven TTF-1 positive tumor who do not have clinical evidence for either lung or thyroid cancer (e.g., a dominant lung mass) are still eligible
    Adequate FFPE tissue samples available
    Measurable disease defined as = 1 lesion whose longest diameter can be accurately measured as = 2.0 cm by conventional techniques OR as = 1.0 cm to = 2 cm by spiral CT scan

    Disease that has received prior radiotherapy for palliative reasons not considered measurable disease
    No untreated brain metastases

    Patients with treated, stable brain metastases for = 12 weeks prior to study entry allowed
    PATIENT CHARACTERISTICS:

    ECOG performance status of 0-2
    ANC = 1,500/mm^3
    Platelet count = 100,000/mm^3
    Hemoglobin = 9.0 g/dL
    Total bilirubin normal (= 2 times upper limit of normal [ULN] in presence of liver metastasis)
    AST = 2.5 times ULN (= 5 times ULN in presence of liver metastasis)
    Creatinine = 1.25 times ULN OR creatinine clearance = 60 mL/min
    Not pregnant or nursing
    Negative pregnancy test
    Fertile patients must agree to use effective contraception
    No co-morbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
    No immunocompromised patients including patients known to be HIV positive
    No uncontrolled intercurrent illness including, but not limited to, the following conditions:

    Ongoing or active infection (acute or chronic)
    Symptomatic congestive heart failure
    Unstable angina pectoris
    Cardiac arrhythmia
    Severely impaired lung function
    Uncontrolled diabetes as defined by fasting serum glucose > 1.5 times ULN
    Liver disease (e.g., cirrhosis, chronic active hepatitis, or chronic persistent hepatitis)
    Psychiatric illness and/or social situations that would limit compliance with study requirements
    More than 5 years since diagnosis of other malignancy except for non-melanotic skin cancer or carcinoma in situ of the cervix
    No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
    No active bleeding diathesis
    No known HIV positivity
    No innoculation with live attenuated vaccines = 2 weeks prior to registration
    PRIOR CONCURRENT THERAPY:

    See Disease Characteristics
    Concurrent bisphosphonates allowed
    No prior chemotherapy for this cancer
    No prior radiotherapy to > 25% bone marrow

    Prior radiotherapy for palliative reasons for this cancer allowed
    No investigational agent within the past 4 weeks that would be considered treatment for the primary neoplasm
    No concurrent chronic systemic treatment with corticosteroids or another immunosuppressive agent

    Topical or inhaled corticosteroids allowed
    No concurrent enzyme-inducing anti-convulsants or other strong inducers or strong inhibitors of CYP3A4 (e.g., carbamazepine, phenytoin, phenobarbital, primidone, rifabutin, rifampin, or St. John wort)
    No concurrent warfarin (coumadin) except for low-molecular weight heparin use
    No concurrent grapefruit, Seville oranges, or star fruit or their juices
    No other concurrent investigational therapy
    No other concurrent anticancer agents


  • Consent Forms: N0871 Consent
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