Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014209
Status:
COMPLETED
Last Update Posted:
2020-04-09
First Post:
2001-04-10
Brief Title:
Combination Chemotherapy in Hodgkins Disease or Non-Hodgkins Lymphoma Not Responding to Previous Treatment
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase II Study Of Gemcitabine Dexamethasone And Cisplatin GDP In Patients With Either Hodgkins Disease Or Aggressive Histology Non-Hodgkins Lymphoma Which Is Relapsed Or Refractory
Status:
COMPLETED
Status Verified Date:
2020-04
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
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have Hodgkins disease or non-Hodgkins lymphoma that has not responded to previous treatment
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have Hodgkins disease or non-Hodgkins lymphoma that has not responded to previous treatment
Detailed Description:
OBJECTIVES
Determine the efficacy of gemcitabine dexamethasone and cisplatin in patients with relapsed or refractory Hodgkins disease or aggressive non-Hodgkins lymphoma
Determine the qualitative and quantitative toxicity of this regimen in these two patient populations
OUTLINE This is a multicenter study Patients are stratified according to disease Hodgkins disease vs non-Hodgkins lymphoma
Patients receive oral dexamethasone on days 1-4 cisplatin IV over 1 hour on day 1 and gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks 3 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 44-88 patients 22-44 per stratum will be accrued for this study within 4-10 months
Determine the efficacy of gemcitabine dexamethasone and cisplatin in patients with relapsed or refractory Hodgkins disease or aggressive non-Hodgkins lymphoma
Determine the qualitative and quantitative toxicity of this regimen in these two patient populations
OUTLINE This is a multicenter study Patients are stratified according to disease Hodgkins disease vs non-Hodgkins lymphoma
Patients receive oral dexamethasone on days 1-4 cisplatin IV over 1 hour on day 1 and gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks 3 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 44-88 patients 22-44 per stratum will be accrued for this study within 4-10 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| LILLY-CAN-NCIC-LY10 | OTHER | None | None |
| CDR0000068518 | OTHER | PDQ | None |