Ignite Creation Date:
2024-05-05 @ 9:11 PM
Last Modification Date:
2024-10-26 @ 10:00 AM
Study NCT ID:
NCT00832637
Status:
TERMINATED
Last Update Posted:
2018-06-29
First Post:
2009-01-13
Brief Title:
Gemcitabine Oxaliplatin Tarceva or Cisplatin in HCC Biliary Tree Cancers
Sponsor:
New Mexico Cancer Care Alliance
Organization:
New Mexico Cancer Care Alliance
Study Overview
Official Title:
Gemcitabine and Cisplatin With Erlotinib in Hepatocellular Carcinoma HCC and Biliary Tree Cancer BTC Intra- and Extra-hepatic Cholangiocarcinoma Bile Duct Cancer Adenocarcinoma of the Ampulla of Vater and Gallbladder Carcinoma
Status:
TERMINATED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Gem-ox
Brief Summary:
This is a single arm phase II trial of Gemcitabine and Oxaliplatin Gem-Ox with Erlotinib Tarceva for the treatment of hepatocellular carcinoma HCC and biliary tree cancer BTC patients with platelet counts 100000µL The purpose of this study is to determine the tumor control rate following treatment with GEM-OX combined with Tarceva in patients with HCC Tumor control rate is defined as the percentage of patients achieving a complete response partial response or stable disease at 24 weeks following treatment
Detailed Description:
The incidence and mortality of HCC has increased in the United States Promising responses have been observed in HCC patients treated with gemcitabine and cisplatin inclusing good disease stabilization and progression free survival Cisplatin-gemcitabine enhances the cytotoxicity of cisplatin by increasing the formation of cytotoxic platinum DNA adducts Similarly Oxaliplatin also has DNA cross linkage properties and one could assume that its combination with gemcitabine is likely to potentiate the cytotoxicity of the latter Erlotinib has also been reported to result in clinical benefit in HCC and BTC patients Based on these prior findings we embarked on this phase II protocol of gemcitabine oxaliplatin and erlotinib in HCC and BTC patients
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2011-02729 | REGISTRY | None | None |
| B9E-US-X467 | OTHER_GRANT | Eli Lilly | None |