Back to resultsPegylated Liposomal Doxorubicin Containing Chemotherapy in the Treatment of Older Non-Hodgkin's Lymphoma Patients
Primary Purpose
Non-Hodgkin's Lymphoma
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CDOP plus rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring NHL, elderly
Eligibility Criteria
Inclusion Criteria: Age 65 years and older; Diagnosis of Non-Hodgkin's lymphoma where therapy with CHOP plus rituximab is considered; Previously untreated; ECOG 0-2 Adequate renal and hepatic functions; Cardiac ejection fraction at least 50% by MUGA. No significant cardiac abnormalities by EKG; Signed informed consent Exclusion Criteria: CNS involvement by lymphoma; Hypersensitivity to study drugs; Active infection; Prior treatment with monoclonal antibodies for cancer; History of cardiac disease with New York Heart Association Class II or greater or clinical evidence of congestive heart failure
Sites / Locations
Outcomes
Primary Outcome Measures
To evaluate the feasibility and tolerability of CDOP plus rituximab in elderly patients with previously untreated NHL.
Secondary Outcome Measures
Tumor response
duration of response
median time to disease progression
overall survival
Full Information
NCT ID
NCT00120198
First Posted
July 8, 2005
Last Updated
November 15, 2007
Sponsor
Geriatric Oncology Consortium
Collaborators
Tibotec Pharmaceutical Limited
1. Study Identification
Unique Protocol Identification Number
NCT00120198
Brief Title
Pegylated Liposomal Doxorubicin Containing Chemotherapy in the Treatment of Older Non-Hodgkin's Lymphoma Patients
Official Title
A Pilot Study of Cyclophosphamide/Pegylated Liposomal Doxorubicin/Vincristine/Prednisone (CDOP) Plus Rituximab for Treatment of Elderly Patients With Previously Untreated Non-Hodgkin's Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Terminated
Why Stopped
slow accrual
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Geriatric Oncology Consortium
Collaborators
Tibotec Pharmaceutical Limited
4. Oversight
5. Study Description
Brief Summary
Currently there is no one standard of care for older patients with Non-Hodgkin's Lymphoma (NHL). The study will examine the tolerability and feasibility to the combination of Cyclophosphamide, Pegylated Liposomal Doxorubicin, Vincristine, Prednisone (CDOP) plus Rituximab.
Detailed Description
Elderly NHL patients tend to tolerate the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) less well when compared to the younger population. Cardiotoxicity, as well as neutropenia, are the most common side effects in the elderly population with age being a risk factor for doxorubicin induced cardiac toxicity. Treatment related toxicity in the older population can preclude adequate therapy and potentially contribute to poor outcomes. Pegylated liposomal doxorubicin has shown similar efficacy with a significant lower incidence of cardiotoxicity ad significantly fewer cardiac events compared with conventional doxorubicin. Exploration of alternative regimens to maximize tolerability and thus enhance overall efficacy in this population is warranted. Both safety and efficacy will be evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
Keywords
NHL, elderly
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
CDOP plus rituximab
Primary Outcome Measure Information:
Title
To evaluate the feasibility and tolerability of CDOP plus rituximab in elderly patients with previously untreated NHL.
Secondary Outcome Measure Information:
Title
Tumor response
Title
duration of response
Title
median time to disease progression
Title
overall survival
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 65 years and older;
Diagnosis of Non-Hodgkin's lymphoma where therapy with CHOP plus rituximab is considered;
Previously untreated;
ECOG 0-2
Adequate renal and hepatic functions;
Cardiac ejection fraction at least 50% by MUGA. No significant cardiac abnormalities by EKG;
Signed informed consent
Exclusion Criteria:
CNS involvement by lymphoma;
Hypersensitivity to study drugs;
Active infection;
Prior treatment with monoclonal antibodies for cancer;
History of cardiac disease with New York Heart Association Class II or greater or clinical evidence of congestive heart failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lodovico Balducci, MD
Organizational Affiliation
Geriatric Oncology Consortium
Official's Role
Study Chair
Facility Information:
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
City
Lecanto
State/Province
Florida
ZIP/Postal Code
34461
Country
United States
City
Belleville
State/Province
New Jersey
ZIP/Postal Code
07109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pegylated Liposomal Doxorubicin Containing Chemotherapy in the Treatment of Older Non-Hodgkin's Lymphoma Patients
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