Last updated on September 2008

Feasibility Study of CDDP + CPT-11 + PSK for Extensive-Stage Disease (ED) Small Cell Lung Cancer

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Small Cell Lung Cancer
  • Age: Between 20 - 74 Years
  • Gender: Male or Female
  • Other:
    Patients with histologically or cytologically proven small cell lung cancer
    Patients receiving chemotherapy for the first time
    Patients with no indication for radical radiotherapy or surgical resection
    Patients diagnosed as ED* by full staging [chest X ray, chest C, brain CT or MRI,
    abdominal CT or abdominal ultrasonography, whole body bone scintigraphy (may be
    replaced by PET/CT)]
    ED: Patient with distant metastasis including contralateral hilar lymph node
    metastasis, but ipsilateral pleural effusion without distant metastasis is
    Patients with lesions measurable or evaluable by the RECIST criteria
    Patients aged from 20 years to below 75 years
    Patients with preserved organ functions as indicated by the following test values
    (data obtained within 14 days prior to registration) Hemoglobin: ≥9.0 g/dL White
    blood cell count: ≥4,000/mm3, ≤12,000 /mm3 Neutrophil count: ≥ 2,000/mm3 Platelet
    count: ≥100,000 /mm3 GOT, GPT: below 2.5 times the upper limit of normal range for
    individual facility Total bilirubin: ≤1.5 mg/dL Serum creatinine: below the lower
    limit of normal range for individual facility Creatinine clearance: ≥ 60mL/min
    Arterial oxygen tension (PaO2): ≥60 torr (resting)
    Performance status (PS): 0-1
    Absence of serious concurrent cardiac or pulmonary disease
    Patients expected to survive for at least 3 months
    Patients from whom written informed consent can be obtained

You may not be eligible for this study if the following are true:

  • Patients with serious infection and other serious complications (including
    gastrointestinal bleeding and diarrhea)
    Patients with pleural effusion, ascites, or pericardial effusion that requires
    treatments including puncture drainage and intracavity administration
    Patients showing definite interstitial pneumonitis or pulmonary fibrosis on plain
    chest radiograph
    Patients manifesting central nervous system symptoms due to brain metastasis at
    Patients with active multiple cancers
    Patients who had undergone bone marrow transplantation
    Patients who had undergone peripheral blood stem cell transplantation
    Patients with a history of definite drug allergy
    Pregnant and nursing patients, patients who may be pregnant or who intend to become
    Male patients with reproductive capacity who have no intention of contraception
    during the clinical trial
    Patients with poorly controlled diabetes
    Patients who had been administered Krestin in the past
    Others: patients who are judged by the investigator or subinvestigator to be
    unsuitable as subject

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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