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

Non-Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00120198
• Other study ID #: GOC-LY-010
• Status: Terminated
• Phase: Phase 2
• First received: July 8, 2005
• Last updated: November 15, 2007
• Start date: March 2005
• Est. completion date: September 2006

Study information

• Verified date: November 2007
• Source: Geriatric Oncology Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• CDOP plus rituximab

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Geriatric Oncology Consortium	Tibotec Pharmaceutical Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the feasibility and tolerability of CDOP plus rituximab in elderly patients with previously untreated NHL.
Secondary	Tumor response
Secondary	duration of response
Secondary	median time to disease progression
Secondary	overall survival