Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006117
Status:
UNKNOWN
Last Update Posted:
2009-10-30
First Post:
2000-08-03
Brief Title:
Gemcitabine and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Gemcitabine Plus Oxaliplatin in Patients With Locally Advanced or Metastatic Pancreatic Cancer
Status:
UNKNOWN
Status Verified Date:
2009-10
Last Known Status:
ACTIVE_NOT_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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of gemcitabine and oxaliplatin in treating patients who have locally advanced or metastatic pancreatic cancer
PURPOSE Phase II trial to study the effectiveness of gemcitabine and oxaliplatin in treating patients who have locally advanced or metastatic pancreatic cancer
Detailed Description:
OBJECTIVES I Determine the objective tumor response rate in patients with locally advanced or metastatic pancreatic carcinoma when treated with gemcitabine and oxaliplatin II Determine the tolerablility and clinical benefit of this regimen in these patients III Evaluate the progression free survival and the overall survival of these patients when treated with this regimen
OUTLINE This is a multicenter study Patients receive gemcitabine IV on day 1 over 15 hours and oxaliplatin IV over 2 hours on day 2 Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity Patients with locally advanced disease receive 6-8 courses and then may undergo surgery radiotherapy andor additional chemotherapy
PROJECTED ACCRUAL A total of 66 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive gemcitabine IV on day 1 over 15 hours and oxaliplatin IV over 2 hours on day 2 Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity Patients with locally advanced disease receive 6-8 courses and then may undergo surgery radiotherapy andor additional chemotherapy
PROJECTED ACCRUAL A total of 66 patients will be accrued for this study
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 |
|---|---|---|---|
| EU-20027 | None | None | None |
| FRE-GERCOR-GEMOX-D99-2 | None | None | None |