Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003810
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase II Study of Gemcitabine and Docetaxel in Pancreatic Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2023-06
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more that one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining gemcitabine and docetaxel in treating patients who have locally advanced or metastatic cancer of the pancreas
PURPOSE Phase II trial to study the effectiveness of combining gemcitabine and docetaxel in treating patients who have locally advanced or metastatic cancer of the pancreas
Detailed Description:
OBJECTIVES I Determine the objective response rate of patients with pancreatic adenocarcinoma treated with combination gemcitabine and docetaxel II Determine the toxicity profile of this combination therapy in these patients III Assess the survival rate of these patients
OUTLINE Patients receive docetaxel IV over 1 hour followed by gemcitabine IV over 30 minutes Patients receive treatment every other week for 8 weeks 4 courses Patients may continue treatment in the absence of unacceptable toxicity or disease progression Patients are followed every 12 weeks until death
PROJECTED ACCRUAL This study will accrue approximately 10 patients per month for a maximum of 33 patients
OUTLINE Patients receive docetaxel IV over 1 hour followed by gemcitabine IV over 30 minutes Patients receive treatment every other week for 8 weeks 4 courses Patients may continue treatment in the absence of unacceptable toxicity or disease progression Patients are followed every 12 weeks until death
PROJECTED ACCRUAL This study will accrue approximately 10 patients per month for a maximum of 33 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 |
|---|---|---|---|
| ECOG-1298 | None | None | None |