Ignite Creation Date:
2024-05-06 @ 1:08 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03943043
Status:
UNKNOWN
Last Update Posted:
2020-07-29
First Post:
2018-04-09
Brief Title:
Gemcitabine Oxaliplatin Nab-paclitaxel in Subjects With Advanced Biliary Tract Cancer
Sponsor:
Istituto Clinico Humanitas
Organization:
Istituto Clinico Humanitas
Study Overview
Official Title:
A Multicenter Phase I-II Trial of Gemcitabine Plus Oxaliplatin and Nab-paclitaxel in Subjects With Advanced Unresectable or Metastatic Biliary Tract Cancer
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
RECRUITING
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:
The objective of the study is to determine a new combination of drug that improves the outcome in patients with advanced unresectable or metastatic BTC The primary objective of the phase I part of the study is to determine the maximum tolerated dose MTD of the combination gemcitabine plus oxaliplatin plus nab-paclitaxel established in the first cycle of therapy in order to determine the recommended phase II dose RP2D
The primary objective of the phase II is to determine activity of GEMOX plus nab-paclitaxel The secondary objectives of the study consist in to better define the safety profile and the outcome of the study treated population
The primary objective of the phase II is to determine activity of GEMOX plus nab-paclitaxel The secondary objectives of the study consist in to better define the safety profile and the outcome of the study treated population
Detailed Description:
Systemic chemotherapy is increasingly being applied in cases of biliary tract cancers A benefit for chemotherapy over best supportive care alone was suggested in a trial that randomly assigned 90 patients with advanced pancreatic or biliary cancer 37 with bile duct cancer to fluorouracil FU-based systemic chemotherapy or best supportive care alone median survival 6 versus 25 months respectively 1
The literature regarding treatment results with specific regimens is limited because most series are small and many reports consist of a mix of bile duct cancers gallbladder cancer ampullary cancer and either pancreatic or hepatocellular cancers Although they arise in similar locations these cancers all have a unique natural history and response to chemotherapy In general no single drug or combination has consistently increased median survival beyond the expected six to eight months
The literature regarding treatment results with specific regimens is limited because most series are small and many reports consist of a mix of bile duct cancers gallbladder cancer ampullary cancer and either pancreatic or hepatocellular cancers Although they arise in similar locations these cancers all have a unique natural history and response to chemotherapy In general no single drug or combination has consistently increased median survival beyond the expected six to eight months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2016-004118-84 | EUDRACT_NUMBER | None | None |