Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004884
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2000-03-07
Brief Title:
Docetaxel and Gemcitabine Compared With Docetaxel and Cisplatin in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Randomized Phase II Study of DocetaxelGemcitabine vs DocetaxelCisplatin in Metastatic or Locoregionally Advanced Pancreatic Carcinoma
Status:
COMPLETED
Status Verified Date:
2012-09
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 than one drug may kill more tumor cells It is not yet known whether docetaxel plus gemcitabine is more effective than docetaxel plus cisplatin in treating advanced pancreatic cancer
PURPOSE Randomized phase II trial to compare the effectiveness of docetaxel and gemcitabine with that of docetaxel and cisplatin in treating patients who have metastatic or locally advanced pancreatic cancer
PURPOSE Randomized phase II trial to compare the effectiveness of docetaxel and gemcitabine with that of docetaxel and cisplatin in treating patients who have metastatic or locally advanced pancreatic cancer
Detailed Description:
OBJECTIVES I Assess the efficacy of docetaxel and gemcitabine vs docetaxel and cisplatin in patients with metastatic or locoregionally advanced pancreatic cancer II Assess the toxicity response rate duration of response time to progression survival performance status and weight associated with these treatment regimens in these patients
OUTLINE This is a randomized open label multicenter study Patents are randomized to one of two treatment arms Arm I Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8 Arm II Patients receive docetaxel IV over 1 hour followed by cisplatin IV over 1 hour on day 1 Treatment is repeated every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 6 weeks until disease progression and then every 8 weeks until death
PROJECTED ACCRUAL Up to 82 patients 41 per arm will be accrued for this study
OUTLINE This is a randomized open label multicenter study Patents are randomized to one of two treatment arms Arm I Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8 Arm II Patients receive docetaxel IV over 1 hour followed by cisplatin IV over 1 hour on day 1 Treatment is repeated every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 6 weeks until disease progression and then every 8 weeks until death
PROJECTED ACCRUAL Up to 82 patients 41 per arm 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 |
|---|---|---|---|
| EORTC-40984 | None | None | None |