Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075686
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
2004-01-09
Brief Title:
S0205 Gemcitabine w or wo Cetuximab as First-Line Therapy in Locally Advanced Pancreas Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab IMC-C225 Versus Gemcitabine As First-Line Therapy Of Patients With Advanced Pancreas Cancer
Status:
COMPLETED
Status Verified Date:
2015-11
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 such as gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells It is not yet known whether gemcitabine is more effective with or without cetuximab in treating pancreatic cancer
PURPOSE This randomized phase III trial is studying giving gemcitabine together with cetuximab to see how well it works compared to giving gemcitabine alone as first-line therapy in treating patients with locally advanced unresectable or metastatic adenocarcinoma of the pancreas
PURPOSE This randomized phase III trial is studying giving gemcitabine together with cetuximab to see how well it works compared to giving gemcitabine alone as first-line therapy in treating patients with locally advanced unresectable or metastatic adenocarcinoma of the pancreas
Detailed Description:
OBJECTIVES
Compare the overall survival of patients with locally advanced unresectable or metastatic adenocarcinoma of the pancreas treated with gemcitabine and cetuximab vs gemcitabine alone
Compare the time to treatment failure in patients treated with these regimens
Estimate the percentage of patients with epidermal growth factor receptor EGFR tumor expression in patients treated with these regimens
Compare the overall survival of patients in the EGFR-positive subset treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the total response rate confirmed and unconfirmed complete and partial response in patients with measurable disease treated with these regimens
Compare the patient report of pain and quality of life of patients treated with these regimens
OUTLINE This is an open-label randomized multicenter study Patients are stratified according to disease status locally advanced unresectable vs metastatic Zubrod performance status 0 or 1 vs 2 and prior pancreatectomy yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cetuximab IV over 1-2 hours on days 1 8 15 and 22 and gemcitabine IV over 30 minutes on days 1 8 15 and 22 for course 1 and days 1 8 and 15 for all subsequent courses
Arm II Patients receive gemcitabine as in arm I In both arms courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline before each course and at the end of study therapy
Patients are followed every 6 months for 2 years and then annually for 1 year
PROJECTED ACCRUAL A total of 704 patients 352 per treatment arm will be accrued for this study within 5 years
Compare the overall survival of patients with locally advanced unresectable or metastatic adenocarcinoma of the pancreas treated with gemcitabine and cetuximab vs gemcitabine alone
Compare the time to treatment failure in patients treated with these regimens
Estimate the percentage of patients with epidermal growth factor receptor EGFR tumor expression in patients treated with these regimens
Compare the overall survival of patients in the EGFR-positive subset treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the total response rate confirmed and unconfirmed complete and partial response in patients with measurable disease treated with these regimens
Compare the patient report of pain and quality of life of patients treated with these regimens
OUTLINE This is an open-label randomized multicenter study Patients are stratified according to disease status locally advanced unresectable vs metastatic Zubrod performance status 0 or 1 vs 2 and prior pancreatectomy yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cetuximab IV over 1-2 hours on days 1 8 15 and 22 and gemcitabine IV over 30 minutes on days 1 8 15 and 22 for course 1 and days 1 8 and 15 for all subsequent courses
Arm II Patients receive gemcitabine as in arm I In both arms courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline before each course and at the end of study therapy
Patients are followed every 6 months for 2 years and then annually for 1 year
PROJECTED ACCRUAL A total of 704 patients 352 per treatment arm will be accrued for this study within 5 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 |
|---|---|---|---|
| S0205 | OTHER | None | None |
| CALGB-S0205 | OTHER | None | None |
| CAN-NCIC-PAC1 | OTHER | None | None |
| U10CA032102 | NIH | NCIC-CTG | httpsreporternihgovquickSearchU10CA032102 |