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

July 8, 2005
November 15, 2007
March 2005
Not Provided
To evaluate the feasibility and tolerability of CDOP plus rituximab in elderly patients with previously untreated NHL.
Same as current
Complete list of historical versions of study NCT00120198 on ClinicalTrials.gov Archive Site
  • Tumor response
  • duration of response
  • median time to disease progression
  • overall survival
Same as current
Not Provided
Not Provided
 
Pegylated Liposomal Doxorubicin Containing Chemotherapy in the Treatment of Older Non-Hodgkin's Lymphoma Patients
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

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma
Drug: CDOP plus rituximab
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
50
September 2006
Not Provided

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00120198
GOC-LY-010
Not Provided
Not Provided
Geriatric Oncology Consortium
Tibotec Pharmaceutical Limited
Study Chair: Lodovico Balducci, MD Geriatric Oncology Consortium
Geriatric Oncology Consortium
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP