Safety And Efficacy Of Irinotecan Plus Capecitabine As First-Line Treatment In Asian Subjects With Hepatocellular Carcinoma
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00635323
First received: March 5, 2008
Last updated: April 2, 2008
Last verified: April 2008
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Purpose
To evaluate the safety and efficacy of irinotecan and capecitabine in Asian subjects with inoperable hepatocellular carcinoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Hepatocellular |
Drug: Irinotecan plus capecitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Overall response rate [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to progression [ Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year ] [ Designated as safety issue: No ]
- Duration of overall response [ Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year ] [ Designated as safety issue: No ]
- Overall tumour growth control rate [ Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year ] [ Designated as safety issue: Yes ]
- Physical exam [ Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year ] [ Designated as safety issue: Yes ]
- Laboratory tests [ Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 73 |
| Study Start Date: | November 2002 |
| Study Completion Date: | May 2005 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00635323
Locations
| China | |
| Pfizer Investigational Site | |
| Shanghai, China, 200433 | |
| Hong Kong | |
| Pfizer Investigational Site | |
| Hong Kong SAR, Hong Kong | |
| Korea, Republic of | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 135-710 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 138-736 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 152-703 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 136-705 | |
| Taiwan | |
| Pfizer Investigational Site | |
| Keelung, Taiwan, 204 | |
| Pfizer Investigational Site | |
| Taipei, Taiwan, 112 | |
| Pfizer Investigational Site | |
| Taipei, Taiwan | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00635323 History of Changes |
| Other Study ID Numbers: | XRP4174/2501, A5961080 |
| Study First Received: | March 5, 2008 |
| Last Updated: | April 2, 2008 |
| Health Authority: | Korea: Independent Review Committee |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Irinotecan Capecitabine Fluorouracil |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 18, 2013