Clinical trial NCT00120198: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Keywords: NHL
elderly
Lead sponsor: Geriatric Oncology Consortium
Sponsor class: OTHER
Collaborators: name: Tibotec Pharmaceutical Limited
First posted: 2005-07-15
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To evaluate the feasibility and tolerability of CDOP plus rituximab in elderly patients with previously untreated NHL.
Secondary outcomes:
measure: Tumor response
measure: duration of response
measure: median time to disease progression
measure: overall survival
Other outcomes:
Locations:
city: Oxnard
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Inverness
country: United States
state: Florida
city: Lecanto
country: United States
state: Florida
city: Belleville
country: United States
state: New Jersey
Study officials:
affiliation: Geriatric Oncology Consortium
name: Lodovico Balducci, MD
role: STUDY_CHAIR
References: