NIPH Clinical Trials Search

UMIN ID: C000000150

Registered date:09/09/2005

A Phase I/II Study of Amrubicine and Irinotecan in Patients with Advanced Small Cell Lung Cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedsmall cell lung cancer
Date of first enrollment2004/03/01
Target sample size40
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)The Amrubicine is administered on day 1-3, and the Irinotecan is administered on day 1 and 8 every three weeks.


Primary OutcomePhase I: to determine the maximum tolerated dose and the recommended dose for phase II study Phase II: to confirm the efficacy and toxicity of the combined therapy at the recommended dose
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum70years-old
GenderMale and Female
Include criteria
Exclude criteriaPresence of pulmonary fibrosis with symptoms or apparent abnormality on chest X-rays, 2) Acute inflammation, infection 3) Massive pleural effusion or pericardial effusion 4) Uncontrollable diabetes mellitus 5) ileus, intestinal paralysis, diarrhea 6) Symptomatic brain metastasis 7) Severe heart disease 8) Pregnancy 9) Severe drug allergies 10) Prior radiotherapy to the chest or the pelvis.

Related Information


public contact
Name Shinichiro Nakamura
Address Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN Japan
Telephone 06-6633-7400
Affiliation West Japan Oncology Group WJOG datacenter
scientific contact
Name Yoichi Nakanishi
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan Japan
Telephone 092-642-5378
Affiliation Kyushu University Hospital Research institute for the disease of the chest