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

This study has been terminated.
(slow accrual)
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by:
Geriatric Oncology Consortium
ClinicalTrials.gov Identifier:
NCT00120198
First received: July 8, 2005
Last updated: November 15, 2007
Last verified: November 2007
History of Changes
  Purpose

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 Intervention Phase
Non-Hodgkin's Lymphoma
 Drug: CDOP plus rituximab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by Geriatric Oncology Consortium:

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

Estimated Enrollment: 50
Study Start Date: March 2005
Study Completion Date: September 2006
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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00120198

Locations
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
Investigators
Study Chair: Lodovico Balducci, MD Geriatric Oncology Consortium
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00120198     History of Changes
Other Study ID Numbers: GOC-LY-010
Study First Received: July 8, 2005
Last Updated: November 15, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Geriatric Oncology Consortium:
NHL
elderly

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Doxorubicin
 Rituximab
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 16, 2012