Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250822
Status:
COMPLETED
Last Update Posted:
2011-10-05
First Post:
2005-11-04
Brief Title:
Gemcitabine and Oxaliplatin for Hepatocellular Carcinoma With Platelet Counts Greater Than 100000 Per Microliter
Sponsor:
New Mexico Cancer Care Alliance
Organization:
New Mexico Cancer Care Alliance
Study Overview
Official Title:
Single Arm Non Randomized Phase II Trial of Gemcitabine and Oxaliplatin GEM-OX for Hepatocellular Carcinoma HCC Patients With Platelet Counts Greater Than 100000 Per Microliter
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the primary end point response rate of the combinations of Gemcitabine and Oxaliplatin Gem-Ox in the treatment of hepatocellular carcinoma HCC in patients with platelet counts greater 100000 per microliter in a single arme Phase II trial
To determine the toxicity profile of this regimen To determine the effect of this treatment on patient survival time to treatment failure time ot progression time to response
To determine the toxicity profile of this regimen To determine the effect of this treatment on patient survival time to treatment failure time ot progression time to response
Detailed Description:
The treatment plan is a two-step design Day 1 the pt will receive Gemcitabine IV and Day 2 the pt will receive Oxaliplatin IV This treatment cycle is repeated approximately every 28 days Subsequent treatment cycle dosages are based on toxicity diaries and lab work results CT scans are repeated every 2 treatment cycles Continuation in the study is dependent upon tumor response
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