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

Sponsor

Geriatric Oncology Consortium (Other)

Overall Status

Terminated

CT.gov ID

NCT00120198

Collaborator

Tibotec Pharmaceutical Limited (Industry)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's Lymphoma	Drug: CDOP plus rituximab	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Mar 1, 2005

Actual Study Completion Date :

Sep 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Oxnard	California	United States	93030
2	Washington	District of Columbia	United States	20007
3	Inverness	Florida	United States	34452
4	Lecanto	Florida	United States	34461
5	Belleville	New Jersey	United States	07109