Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023972
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
2001-09-13
Brief Title:
Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Randomized Open-Label Multicenter Phase III Study Comparing the Efficacy and Safety of a Combination of Intravenous DX-8951f Exatecan Mesylate Plus Gemcitabine to Gemcitabine Alone in Patients With Locally Advanced or Metastatic Cancer of the Exocrine Pancreas Who Have Not Received Prior Chemotherapy
Status:
COMPLETED
Status Verified Date:
2012-05
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 It is not yet known if gemcitabine is more effective with or without exatecan mesylate in treating pancreatic cancer
PURPOSE Randomized phase III trial to compare the effectiveness of gemcitabine alone to that of gemcitabine and exatecan mesylate in treating patients who have locally advanced or metastatic pancreatic cancer
PURPOSE Randomized phase III trial to compare the effectiveness of gemcitabine alone to that of gemcitabine and exatecan mesylate in treating patients who have locally advanced or metastatic pancreatic cancer
Detailed Description:
OBJECTIVES
Compare the overall survival of patients with chemotherapy-naive locally advanced or metastatic cancer of the exocrine pancreas treated with exatecan mesylate and gemcitabine versus gemcitabine alone
Compare the measures of clinical benefit in patients treated with these regimens
Compare the anti-tumor efficacy of these regimens in this patient population
Determine the safety profile of exatecan mesylate and gemcitabine in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to performance status 60 vs 70-80 vs 90-100 extent of disease locally advanced vs metastatic and prior radiotherapy for pancreatic cancer yes or no Patients are randomized to one of two treatment arms
Arm I Patients receive exatecan mesylate DX-8951f IV over 30 minutes immediately followed by gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Arm II Patients receive gemcitabine IV over 30 minutes once weekly for up to 7 weeks followed by one week of rest course 1 For all subsequent courses patients receive gemcitabine once weekly for 3 weeks followed by one week of rest Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed monthly
PROJECTED ACCRUAL Approximately 340 patients 170 per treatment arm will be accrued for this study within 18 months
Compare the overall survival of patients with chemotherapy-naive locally advanced or metastatic cancer of the exocrine pancreas treated with exatecan mesylate and gemcitabine versus gemcitabine alone
Compare the measures of clinical benefit in patients treated with these regimens
Compare the anti-tumor efficacy of these regimens in this patient population
Determine the safety profile of exatecan mesylate and gemcitabine in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to performance status 60 vs 70-80 vs 90-100 extent of disease locally advanced vs metastatic and prior radiotherapy for pancreatic cancer yes or no Patients are randomized to one of two treatment arms
Arm I Patients receive exatecan mesylate DX-8951f IV over 30 minutes immediately followed by gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Arm II Patients receive gemcitabine IV over 30 minutes once weekly for up to 7 weeks followed by one week of rest course 1 For all subsequent courses patients receive gemcitabine once weekly for 3 weeks followed by one week of rest Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed monthly
PROJECTED ACCRUAL Approximately 340 patients 170 per treatment arm will be accrued for this study within 18 months
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 |
|---|---|---|---|
| MSKCC-02011 | None | None | None |
| DAIICHI-8951A-PRT031 | None | None | None |