Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351195
Status:
TERMINATED
Last Update Posted:
2008-08-26
First Post:
2006-07-11
Brief Title:
Etoposide Oxaliplatin and Capecitabine in Advanced Hepatocellular Carcinoma HCC
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
A Phase II Study of Etoposide Oxaliplatin and Capecitabine in Patients With Advanced HCC
Status:
TERMINATED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Did not meet the criteria for continuation to second stage
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Various cytotoxic agents have been evaluated in advanced hepatocellular carcinoma but response rates have been low with significant toxicity most often due to parenchymal liver disease The three agents etoposide oxaliplatin and capecitabine each has sparse efficacy as single agents but the combination may act synergistically with an acceptable toxicity profile
Detailed Description:
Design
Open phase II study
Purpose
Response rate for the combination of etoposide oxaliplatin and capecitabine given every 3 weeks on an outpatient basis
Secondary endpoint are safety time to progression and survival
Treatment
Etoposide are administered intravenously 100 mgm2 on day 1 and orally 200 mgm2 on days 2 and 3
Capecitabine Xeloda are administered 1000 mgm2 twice daily with 12 hours interval for two weeks and one week off
Oxaliplatin are administered intravenously 100 mgm2 on day 1 in each cycle as a 2 hours infusion
One cycle is 3 weeks
Open phase II study
Purpose
Response rate for the combination of etoposide oxaliplatin and capecitabine given every 3 weeks on an outpatient basis
Secondary endpoint are safety time to progression and survival
Treatment
Etoposide are administered intravenously 100 mgm2 on day 1 and orally 200 mgm2 on days 2 and 3
Capecitabine Xeloda are administered 1000 mgm2 twice daily with 12 hours interval for two weeks and one week off
Oxaliplatin are administered intravenously 100 mgm2 on day 1 in each cycle as a 2 hours infusion
One cycle is 3 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None