Safety And Efficacy Of Irinotecan Plus Capecitabine As First-Line Treatment In Asian Subjects With Hepatocellular Carcinoma
NCT00635323
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Asian subjects with histologically or cytologically confirmed hepatocellular carcinoma
- Inoperable disease (unable to completely remove surgically, presence of extra-hepatic disease, main portal vein or hepatic vein involvement)
- Eastern Cooperative Oncology Group performance status of ?2
- Decompensated cirrhosis or stage C (Index>10) according to the Child-Pugh
Classification
- Current history of chronic diarrhoea
- Reproductive potential not using adequate contraceptive measures
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Calgary, Alberta
- Toronto, Ontario
- Montreal, Quebec
- San Francisco, California
- Chicago, Illinois
- Fountain Valley, California
- La Jolla, California
- La Jolla, California
- Orange, California
- San Diego, California
- Miami, Florida
- Ringgold, Georgia
- Iowa City, Iowa
- Crestview Hills, Kentucky
- Bronx, New York
- Cincinnati, Ohio
- Cincinnati, Ohio
- Cincinnati, Ohio
- Cincinnati, Ohio
- Cincinnati, Ohio
- Cincinnati, Ohio
- Fairfield, Ohio
- Hamilton, Ohio
- Chattanooga, Tennessee
- Franklin, Tennessee
- Gallatin, Tennessee
- Hermitage, Tennessee
- Hixson, Tennessee
- Lebanon, Tennessee
- Murfreesboro, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Smyrna, Tennessee
- Mechanicsville, Virginia
- Midlothian, Virginia
- Richmond, Virginia
- Richmond, Virginia
- Seattle, Washington
- Concord, New South Wales
- Elizabeth Vale, South Australia
- Woodville South, South Australia
- Melbourne, Victoria
- Parkville, Victoria
- Bruxelles,
- Bruxelles,
- Gent,
- Calgary, Alberta
- Vancouver, British Columbia
- Kingston, Ontario
- Toronto, Ontario
- Montreal, Quebec
- Hefei, Anhui
- Fuzhou City, Fujian
- Guangzhou, Guangdong
- Guangzhou, Guangdong
- Nanning, Guangxi
- Wuhan, Hubei
- Nanjing, Jiangsu
- Chengdu, Sichuan
- Hangzhou, Zhejiang
- Hangzhou, Zhejiang
- Beijing,
- Beijing,
- Bejing,
- Chong qing,
- Guangzhou,
- Nanjing,
- Shanghai,
- Amiens Cedex 1,
- Bordeaux Cedex,
- Clichy Cedex,
- Creteil Cedex,
- Lille Cedex,
- Nice Cedex 2,
- Paris Cedex 13,
- Paris,
- St Herblain Cedex,
- Strasbourg Cedex,
- Toulouse,
- Vandoeuvre Les Nancy Cedex,
- Villejuif Cedex,
- Hamburg,
- Hannover,
- Mainz,
- Muenchen,
- Hong Hong,
- Kowloon,
- Shatin, New Territories,
- Tuen Mun, New Territories,
- Meldola, FC
- Bari,
- Bologna,
- Cattolica (RN),
- Milano,
- Milano,
- Padova,
- Pavia,
- Ravenna,
- Rimini,
- Nagoya, Aichi
- Chiba city, Chiba
- Kashiwa-shi, Chiba
- Kurume city, Fukuoka
- Gifu-shi, Gifu
- Sapporo-shi, Hokkaido
- Nishinomiya, Hyogo
- Kanazawa city, Ishikawa
- Omura-shi, Nagasaki
- Osaka-shi, Osaka-fu
- Osaka-Sayama, Osaka
- Izunokuni-shi, Shizuoka
- Bunkyo-ku, Tokyo
- Chiyoda-ku, Tokyo
- Chuo-ku, Tokyo
- Itabashi-ku, Tokyo
- Mitaka-shi, Tokyo
- Setagaya-ku, Tokyo
- Okayama,
- Chonju, Chonbuk
- Goyang-si, Gyeonggi-do
- Hwasun-gun, Jeollanam-do
- Busan,
- Daegu,
- Daegu,
- Incheon,
- Seoul,
- Seoul,
- Seoul,
- Seoul,
- Seoul,
- Lembah Pantai, Kuala Lumpur
- Subang Jaya, Selangor
- Kuala Lumpur,
- Cebu City, Cebu
- Cebu City,
- Davao City,
- Manila,
- Manila,
- Quezon City,
- Quezon City,
- Quezon City,
- Warszawa,
- Warszawa,
- Chelyabinsk,
- Pyatigorsk,
- St.Petersburg,
- Singapore,
- Singapore,
- Parktown,
- Sabadell, Barcelona
- Santander, Cantabria
- Palma de Mallorca, Illes Balears
- El Palmar, Murcia
- Sevilla,
- Linkoping,
- Pu-Tz City, Chai-Yi
- Kwei-Shan, Taoyuan
- Changhua,
- Kaohsiung,
- Kaohsiung,
- Taichung City,
- Taichung,
- Tainan,
- Tainan,
- Taipei,
- Taipei,
- Bangkok Noi, Bangkok
- Ptumwan, Bangkok
- Amphoe Mueang, Chiang Mai
- Ankara,
- Istanbul,
- Cambridge, Cambridgeshire
- London,
- London,
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Safety And Efficacy Of Irinotecan Plus Capecitabine As First-Line Treatment In Asian Subjects With Hepatocellular Carcinoma | |||
Official Title ICMJE | A Phase 2 Study of the Efficacy and Safety of Irinotecan (Campto®) in Combination With Capecitabine (Xeloda®) as First-Line Chemotherapy in Asian Subjects With Inoperable Hepatocellular Carcinoma | |||
Brief Summary | To evaluate the safety and efficacy of irinotecan and capecitabine in Asian subjects with inoperable hepatocellular carcinoma. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Carcinoma, Hepatocellular | |||
Intervention ICMJE | Drug: Irinotecan plus capecitabine
Irinotecan 200-250 mg/m2 intravenous infusion over 30 to 90 minutes on day 1 of a 3-week cycle. Capecitabine 1000 mg/m2 oral tablet twice daily for 14 days followed by a 7 day rest throughout the treatment period for | |||
Study Arms ICMJE | Experimental: A
Intervention: Drug: Irinotecan plus capecitabine | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE | 73 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | May 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China, Hong Kong, Korea, Republic of, Taiwan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00635323 | |||
Other Study ID Numbers ICMJE | XRP4174/2501 A5961080 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | April 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |