Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086801
Status:
COMPLETED
Last Update Posted:
2016-07-01
First Post:
2004-07-08
Brief Title:
Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage I or Stage II Hodgkins Lymphoma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Trial of Doxorubicin Vinblastine and Gemcitabine AVG Chemotherapy for Non-Bulky Stage I and II Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2016-06
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 doxorubicin vinblastine and gemcitabine work in different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells
PURPOSE This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed stage I or stage II Hodgkins lymphoma
PURPOSE This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed stage I or stage II Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the complete response rate in patients with newly diagnosed stage IA IB IIA or IIB non-bulky Hodgkins lymphoma treated with doxorubicin vinblastine and gemcitabine
Secondary
Determine the event-free survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine whether fludeoxyglucose F 18 positron-emission tomography scanning is useful in predicting clinical relapse and determining the presence of residual disease in these patients after treatment with this regimen
OUTLINE This is a multicenter study
Patients receive doxorubicin IV over 3-5 minutes vinblastine IV over 3-5 minutes and gemcitabine IV over 30 minutes on days 1 and 15 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
Patients undergo fludeoxyglucose F 18 positron-emission tomography PET scanning and CT scan before treatment and after courses 2 and 6 of therapy to assess response Patients with a positive PET scan after completion of study therapy may undergo biopsy A PET scan is performed 3 months later if biopsy is negative or biopsy is unable to be performed
Patients are followed every 3 months for 1 year every 4 months for 2 years every 6 months for 2 years and then annually for 5 years
Primary
Determine the complete response rate in patients with newly diagnosed stage IA IB IIA or IIB non-bulky Hodgkins lymphoma treated with doxorubicin vinblastine and gemcitabine
Secondary
Determine the event-free survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine whether fludeoxyglucose F 18 positron-emission tomography scanning is useful in predicting clinical relapse and determining the presence of residual disease in these patients after treatment with this regimen
OUTLINE This is a multicenter study
Patients receive doxorubicin IV over 3-5 minutes vinblastine IV over 3-5 minutes and gemcitabine IV over 30 minutes on days 1 and 15 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
Patients undergo fludeoxyglucose F 18 positron-emission tomography PET scanning and CT scan before treatment and after courses 2 and 6 of therapy to assess response Patients with a positive PET scan after completion of study therapy may undergo biopsy A PET scan is performed 3 months later if biopsy is negative or biopsy is unable to be performed
Patients are followed every 3 months for 1 year every 4 months for 2 years every 6 months for 2 years and then annually for 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 |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CALGB-50203 | None | None | None |
| CDR0000370870 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |