Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052689
Status:
COMPLETED
Last Update Posted:
2013-10-08
First Post:
2003-01-24
Brief Title:
Bortezomib With or Without Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Trial of PS-341 and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2013-10
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:
Randomized phase II trial to compare the effectiveness of bortezomib with or without gemcitabine in treating patients who have metastatic pancreatic cancer Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining bortezomib with gemcitabine may kill more tumor cells
Detailed Description:
OBJECTIVES
I Compare the objective response rate in previously untreated patients with metastatic pancreatic adenocarcinoma treated with bortezomib with or without gemcitabine
II Compare the toxicity of these regimens in these patients III Compare the progression-free 6-month and overall survival of patients treated with these regimens
IV Compare the change in overall quality of life QOL and in subcomponents of QOL of patients after treatment with 2 consecutive courses of these regimens
OUTLINE This is a randomized study Patients are randomized to 1of 2 treatment arms
ARM I Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Patients with progressive disease crossover to arm II
ARM II Patients receive bortezomib as in arm I and gemcitabine IV over 30 minutes on days 1 and 8
Courses in both arms repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Quality of life QOL is assessed at baseline and before courses 2 and 4 Patients who crossover to arm II from arm I complete QOL questionnaires before the first 2 courses of arm II therapy
Patients are followed every 3 months for 1 year and then every 6 months for 4 years
I Compare the objective response rate in previously untreated patients with metastatic pancreatic adenocarcinoma treated with bortezomib with or without gemcitabine
II Compare the toxicity of these regimens in these patients III Compare the progression-free 6-month and overall survival of patients treated with these regimens
IV Compare the change in overall quality of life QOL and in subcomponents of QOL of patients after treatment with 2 consecutive courses of these regimens
OUTLINE This is a randomized study Patients are randomized to 1of 2 treatment arms
ARM I Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Patients with progressive disease crossover to arm II
ARM II Patients receive bortezomib as in arm I and gemcitabine IV over 30 minutes on days 1 and 8
Courses in both arms repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Quality of life QOL is assessed at baseline and before courses 2 and 4 Patients who crossover to arm II from arm I complete QOL questionnaires before the first 2 courses of arm II therapy
Patients are followed every 3 months for 1 year and then every 6 months for 4 years
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 |
|---|---|---|---|
| U10CA025224 | NIH | CTEP | httpsreporternihgovquickSearchU10CA025224 |
| NCI-2012-01799 | REGISTRY | None | None |
| NCCTG-N014C | None | None | None |
| CDR0000258670 | None | None | None |
| N014C | OTHER | None | None |
| N014C | OTHER | None | None |