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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00120198
Recruitment Status : Terminated (slow accrual)
First Posted : July 15, 2005
Last Update Posted : November 16, 2007
Tibotec Pharmaceutical Limited
Information provided by:
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.

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 Type : Interventional  (Clinical Trial)
Estimated 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 : March 2005
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Primary Outcome Measures :
  1. To evaluate the feasibility and tolerability of CDOP plus rituximab in elderly patients with previously untreated NHL.

Secondary Outcome Measures :
  1. Tumor response
  2. duration of response
  3. median time to disease progression
  4. overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00120198

United States, California
Oxnard, California, United States, 93030
United States, District of Columbia
Washington, District of Columbia, United States, 20007
United States, Florida
Inverness, Florida, United States, 34452
Lecanto, Florida, United States, 34461
United States, New Jersey
Belleville, New Jersey, United States, 07109
Sponsors and Collaborators
Geriatric Oncology Consortium
Tibotec Pharmaceutical Limited
Study Chair: Lodovico Balducci, MD Geriatric Oncology Consortium Identifier: NCT00120198     History of Changes
Other Study ID Numbers: GOC-LY-010
First Posted: July 15, 2005    Key Record Dates
Last Update Posted: November 16, 2007
Last Verified: November 2007

Keywords provided by Geriatric Oncology Consortium:

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action