NIPH Clinical Trials Search

UMIN ID: C000000113

Registered date:05/09/2005

phase II study of irinotecan plus cisplatin followed by amrubicin in patients with extensive disease small-cell lung cancer.

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedextensive disease small-cell lung cancer
Date of first enrollment2004/09/01
Target sample size45
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)single-arm phse II study. Patients receive irinotecan 60 mg/m2 intravenously on day 1 and 8 plus cisplatin 60 mg/m2 intravenously on day 1 every three weeks for three cycle, then amrubicin 40 mg/m2 intravenously on day 1 to 3 every three weeks for three cycle.


Primary OutcomePrimary endpoint: response rate. Secondary endpoints: overall survival, time to progression, and toxicity.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum70years-old
GenderMale and Female
Include criteria1) small-cell lung cancer; 2) extensive disease; 3) Eastern Cooperative Oncology Group performance status of 0 or 1; 4) age of 20 to 70 years; 5) no prior chemotherapy; 6) neither palliative radiation nor surgery within 14 days; 7) measurable lesions; 8) a life expectancy of at least two months; 9) adequate organ fanctions; and 10) written informed consent.
Exclude criteria1) symptomatic brain metastases; 2) pleural or pericardial effusion requiring drainage; 3) interstitial pneumonitis or pulmonary fibrosis; 4) active infection; 5) watery diarrhea, paralysis of the intestine, or ileus; 6) active gastric or duodenal ulcer; 7) continuous administration of steroids or non-steroidal anti-inflammatory drugs; 8) uncontrolled diabetes mellitus or angina pectoris; 9) active concomitant malignancies; 10) a history of serious drug allergy; 11) pregnancy or lactation; and 12) unsuitable for entry to the study, decided by a medical oncologist.

Related Information


public contact
Name Shinichiro Nakamura
Address Japan
Telephone 06-6633-7400
Affiliation West Japan Oncology Group WJOG datacenter
scientific contact
Name aoru Matsui (head), Masashi Kobayashi (secretariat)
Address 3-7-1 Habikino, Habikino-shi, Osaka 583-8588, Japan. Japan
Affiliation Osaka Prefectural Medical Center for Respiratory and Allergic Diseases Department of Thoracic Malignancy