Pegylated Liposomal Doxorubicin Containing Chemotherapy in the Treatment of Older Non-Hodgkin's Lymphoma Patients

Phase 2

Terminated

• Conditions: Non-Hodgkin's Lymphoma

• Registration Number: NCT00120198
• Lead Sponsor: Geriatric Oncology Consortium

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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-07-08
• Study First Submitted QC: 2005-07-08
• Study First Posted: 2005-07-15
• Study Completion: 2006-09
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-15
• Last Update Posted: 2007-11-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate the feasibility and tolerability of CDOP plus rituximab in elderly patients with previously untreated NHL.

Secondary Outcome Measures

Name	Time	Method
Tumor response
duration of response
median time to disease progression
overall survival