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

Geriatric Oncology Consortium

Status and phase

Terminated

Phase 2

Conditions

Non-Hodgkin's Lymphoma

Treatments

Drug: CDOP plus rituximab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00120198

GOC-LY-010

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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