Ignite Creation Date:
2024-05-05 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00744640
Status:
COMPLETED
Last Update Posted:
2010-01-12
First Post:
2008-08-29
Brief Title:
Gemcitabine Oxaliplatin and Capecitabine for Advanced Pancreatic Carcinoma
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Gemcitabine Oxaliplatin and Capecitabine GEMOXEL for Patients With Advanced Pancreatic Adenocarcinoma APC A Phase III Study
Status:
COMPLETED
Status Verified Date:
2010-01
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:
GEMOXEL
Brief Summary:
Gemcitabine is the mainstay of palliative chemotherapy for patients with advanced pancreatic cancer APC Recent randomized trials have shown increased clinical benefit with the addition of oxaliplatin and prolonged median survival with the addition of capecitabine to gemcitabine Gemcitabine capecitabine and oxaliplatin are 3 newer well tolerated anticancer drugs with mild and non-overlapping toxicity profiles We therefore propose a dose-finding and safety study of the triple combination gemcitabine capecitabine and oxaliplatin in patients with APC Phase I part followed by a phase II part to assess preliminary efficacy of this triple combination
Detailed Description:
Primary Objectives
Phase I to determine the maximum tolerated dose MTD of oxaliplatin in combination with gemcitabine and capecitabine GEMOXEL in patients with APC
Phase II to assess any anti-tumor activity of GEMOXEL in patients with APC
Secondary Objectives
to assess toxicity and safety of the combination treatment GEMOXEL in patients with APC
Primary Endpoints
Phase I Dose-limiting toxicity
Phase II Objective tumor response
Secondary Endpoints
Toxicity at MTD according to NCI CTC 30
Progression-free survival and Overall Survival
Phase I to determine the maximum tolerated dose MTD of oxaliplatin in combination with gemcitabine and capecitabine GEMOXEL in patients with APC
Phase II to assess any anti-tumor activity of GEMOXEL in patients with APC
Secondary Objectives
to assess toxicity and safety of the combination treatment GEMOXEL in patients with APC
Primary Endpoints
Phase I Dose-limiting toxicity
Phase II Objective tumor response
Secondary Endpoints
Toxicity at MTD according to NCI CTC 30
Progression-free survival and Overall Survival
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 |
|---|---|---|---|
| 2005DR2296 | None | None | None |