Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059865
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2003-05-06
Brief Title:
Gemcitabine Plus Pemetrexed Disodium in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase III Trial Of Gemcitabine And ALIMTA In Patients With Measurable Or Evaluable Unresectable Or Metastatic Biliary Tract Carcinoma Intrahepatic Extrahepatic Ampulla Or Vater And Gallbladder Carcinoma
Status:
COMPLETED
Status Verified Date:
2016-12
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 Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth Combining gemcitabine with pemetrexed disodium may kill more tumor cells
PURPOSE This phase III trial is studying the side effects and best dose of gemcitabine when given together with pemetrexed disodium to see how well it works in treating patients with unresectable or metastatic biliary tract or gallbladder cancer
PURPOSE This phase III trial is studying the side effects and best dose of gemcitabine when given together with pemetrexed disodium to see how well it works in treating patients with unresectable or metastatic biliary tract or gallbladder cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of gemcitabine when administered with pemetrexed disodium in patients with unresectable or metastatic biliary tract or gallbladder cancer Phase I closed to accrual as of Oct 2005
Determine the 6-month survival rate of patients treated with this regimen
Determine the best objective tumor response rate and duration of best objective tumor response in patients treated with this regimen
Determine the time to progression and overall survival of patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine the individual patient variation in toxicity of andor response to this regimen due to genetic differences in proteins involved in drug response in these patients
OUTLINE This is a multicenter phase I dose-escalation study of gemcitabine followed by a phase II study
Phase I Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine IV over 30 minutes on days 1 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity phase I closed to accrual as of October 2005
Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive pemetrexed disodium as in phase I and gemcitabine at the recommended phase II dose
Patients are followed every 3 months for 1 year and then every 6 months for 4 years
PROJECTED ACCRUAL A total of 85 patients will be accrued for this study
Determine the maximum tolerated dose of gemcitabine when administered with pemetrexed disodium in patients with unresectable or metastatic biliary tract or gallbladder cancer Phase I closed to accrual as of Oct 2005
Determine the 6-month survival rate of patients treated with this regimen
Determine the best objective tumor response rate and duration of best objective tumor response in patients treated with this regimen
Determine the time to progression and overall survival of patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine the individual patient variation in toxicity of andor response to this regimen due to genetic differences in proteins involved in drug response in these patients
OUTLINE This is a multicenter phase I dose-escalation study of gemcitabine followed by a phase II study
Phase I Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine IV over 30 minutes on days 1 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity phase I closed to accrual as of October 2005
Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive pemetrexed disodium as in phase I and gemcitabine at the recommended phase II dose
Patients are followed every 3 months for 1 year and then every 6 months for 4 years
PROJECTED ACCRUAL A total of 85 patients 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 |
|---|---|---|---|
| NCI-2012-02530 | REGISTRY | CTRP Clinical Trials Reporting System | None |
| NCCTG-N9943 | None | None | None |
| CDR0000298862 | REGISTRY | None | None |