UMIN ID: UMIN000001615
Registered date:03/01/2009
The efficacy and safety of gemcitabine / cisplatin combination therapy in patients with advanced refractory biliary tract cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Advanced biliary tract cancer refractory to gemcitabine and S-1 |
| Date of first enrollment | 2007/03/01 |
| Target sample size | 20 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Gemcitabine 1,000mg/m2 is administered as a 30min intravenous infusion on day 1 and day 8. Cisplatin 23mg/m2 is administered as 120min intravenous infusion on day 1 and day 8. The cycle is repeated every 3 weeks until disease progression. |
Outcome(s)
| Primary Outcome | response rate |
|---|---|
| Secondary Outcome | Time to progression, Overall survival, Toxicity |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Patients with an active concomitant infection 2) Patients with digestive ulcer or gastrointestinal bleeding 3) Patients with severe cardiovascular or renal disease 4) Patients with an active pulmonary fibrosis or interstitial pneumonia 5) Patients with uncontrollable massive pleural effusion or massive ascites 6) Patients with an active concomitant malignancy 7) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception 8) Patients with a previous history of a severe drug hypersensitivity 9) Patients receiving anti-cancer drugs 10) Inappropriate patients for entry on this study in the judgement of the investigator |
Related Information
| Primary Sponsor | Faculty of Medicine, University of Tokyo |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Takashi Sasaki |
| Address | 7-3-1, Hongo, Bunkyo-ku, Tokyo Japan |
| Telephone | 03-3815-5411 |
| Affiliation | Faculty of Medicine, University of Tokyo Department of Gastroenterology |
| scientific contact | |
| Name | Hiroyuki Isayama |
| Address | 7-3-1, Hongo, Bunkyo-ku, Tokyo Japan |
| Telephone | 03-3815-5411 |
| Affiliation | Faculty of Medicine, University of Tokyo Department of Gastroenterology |