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) studied | small cell lung cancer |
| Date of first enrollment | 2004/03/01 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | The Amrubicine is administered on day 1-3, and the Irinotecan is administered on day 1 and 8 every three weeks. |
Outcome(s)
| Primary Outcome | Phase 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 minimum | 20years-old |
|---|---|
| Age maximum | 70years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Presence 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
| Primary Sponsor | West Japan Oncology Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Shinichiro Nakamura |
| Address | Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN Japan |
| Telephone | 06-6633-7400 |
| datacenter@wjog.jp | |
| 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 |