Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT00351195
Status:
TERMINATED
Last Update Posted:
2008-08-26
First Post:
2006-07-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Etoposide, Oxaliplatin and Capecitabine in Advanced Hepatocellular Carcinoma (HCC)
Sponsor:
Rigshospitalet, Denmark
Organization:
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 mg/m2 on day 1 and orally 200 mg/m2 on days 2 and 3.
Capecitabine (Xeloda) are administered 1000 mg/m2 twice daily with 12 hours interval for two weeks and one week off
Oxaliplatin are administered intravenously 100 mg/m2 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 mg/m2 on day 1 and orally 200 mg/m2 on days 2 and 3.
Capecitabine (Xeloda) are administered 1000 mg/m2 twice daily with 12 hours interval for two weeks and one week off
Oxaliplatin are administered intravenously 100 mg/m2 on day 1 in each cycle as a 2 hours infusion.
One cycle is 3 weeks.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: