Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006029
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
2000-07-05
Brief Title:
Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkins Lymphoma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase III Study of Gemcitabine GEMZARVinorelbine NAVELBINELiposomal Doxorubicin DOXIL in RelapsedRefractory Hodgkins Disease
Status:
COMPLETED
Status Verified Date:
2016-07
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 III trial to study the effectiveness of combination chemotherapy in treating patients who have relapsed or refractory Hodgkins lymphoma
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy in treating patients who have relapsed or refractory Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and toxicity of gemcitabine vinorelbine and doxorubicin HCl liposome in patients with relapsed or refractory Hodgkins lymphoma
Determine the complete and partial response rates of patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study
Phase I
Patients receive vinorelbine IV over 6-10 minutes gemcitabine IV over 30 minutes and doxorubicin HCl liposome IV over 30-60 minutes on days 1 and 8 Treatment continues every 21 days for 2-6 courses in the absence of unacceptable toxicity or disease progression Patients who respond to treatment after 2 or more courses may stop protocol therapy to undergo peripheral blood stem cell transplantation
Cohorts of 3-6 patients receive escalating doses of vinorelbine gemcitabine and doxorubicin HCl liposome 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 Once the MTD is determined additional patients are accrued to receive treatment with gemcitabine vinorelbine and doxorubicin HCl liposome at the recommended phase II dose
Phase II
Patients are assigned to 1 of 2 treatment groups
Group 1 Patients who have not undergone prior transplantation receive vinorelbine gemcitabine and doxorubicin HCl liposome as in phase I
Group 2 Patients who have undergone prior transplantation receive lower doses of vinorelbine gemcitabine and doxorubicin HCl liposome as in group 1
Patients are followed every 6 months for 2 years and then annually for 6 years
PROJECTED ACCRUAL Approximately 3-100 patients 3-42 for phase I and 20-58 for phase II 29 per group will be accrued for this study within 3 years
Determine the maximum tolerated dose and toxicity of gemcitabine vinorelbine and doxorubicin HCl liposome in patients with relapsed or refractory Hodgkins lymphoma
Determine the complete and partial response rates of patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study
Phase I
Patients receive vinorelbine IV over 6-10 minutes gemcitabine IV over 30 minutes and doxorubicin HCl liposome IV over 30-60 minutes on days 1 and 8 Treatment continues every 21 days for 2-6 courses in the absence of unacceptable toxicity or disease progression Patients who respond to treatment after 2 or more courses may stop protocol therapy to undergo peripheral blood stem cell transplantation
Cohorts of 3-6 patients receive escalating doses of vinorelbine gemcitabine and doxorubicin HCl liposome 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 Once the MTD is determined additional patients are accrued to receive treatment with gemcitabine vinorelbine and doxorubicin HCl liposome at the recommended phase II dose
Phase II
Patients are assigned to 1 of 2 treatment groups
Group 1 Patients who have not undergone prior transplantation receive vinorelbine gemcitabine and doxorubicin HCl liposome as in phase I
Group 2 Patients who have undergone prior transplantation receive lower doses of vinorelbine gemcitabine and doxorubicin HCl liposome as in group 1
Patients are followed every 6 months for 2 years and then annually for 6 years
PROJECTED ACCRUAL Approximately 3-100 patients 3-42 for phase I and 20-58 for phase II 29 per group will be accrued for this study within 3 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 |
|---|---|---|---|
| CLB-59804 | None | None | None |
| CDR0000068042 | REGISTRY | NCI Physician Data Query | None |