feasibility study of cddp + cpt-11 + psk for extensive-stage disease (ed) small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: the purpose of this study is to examine whether setting test groups of cisplatin + irinotecan + krestin therapy as first-line treatment and chemotherapy (radiotherapy or radiotherapy + chemotherapy also allowed) combined with krestin as second-line treatment after exacerbation and comparing with historical control or community control is appropriate as the protocol and regimen for the phase iii clinical trial on extensive-stage disease (ed) small cell lung cancer.

to examine whether the following protocol and regimen is appropriate for the phase iii clinical trial on extensive-stage disease (ed) small cell lung cancer: set test groups of cisplatin + irinotecan + krestin therapy as first-line treatment and chemotherapy (radiotherapy or radiotherapy + chemotherapy also allowed) combined with krestin as second-line treatment after exacerbation, evaluate the efficacy and safety of treatment in a small number of cases, and compare with historical control or community control.

Eligibility criteria:
inclusion criteria: * 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 excluded. * 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 exclusion criteria: * 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 registration * 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 pregnant * 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

Keywords: ed-sclc small cell lung cancer cpt-11 irinotecan hydrochloride cddp cisplatin psk krestin