A Dose Study of Doxil in a Dose Dense, 14 Day CDOP/Rituximab Regimen for Patients With Diffuse Large B-Cell Non-Hodgkin Lymphoma (NHL)> 60 Years or With Compromised Cardiac Status.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by The Alvin and Lois Lapidus Cancer Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ortho Biotech Products, L.P.
Information provided by:
The Alvin and Lois Lapidus Cancer Institute
ClinicalTrials.gov Identifier:
NCT00333008
First received: May 31, 2006
Last updated: September 25, 2006
Last verified: September 2006

May 31, 2006
September 25, 2006
May 2006
Not Provided
  • Safety assessment: National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) v3.0
  • Efficacy: tumor evaluations every three (q 3) cycles
  • Safety assessment: NCI CTACAE v3.0
  • Efficacy: tumor evaluations q 3 cycles
Complete list of historical versions of study NCT00333008 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Dose Study of Doxil in a Dose Dense, 14 Day CDOP/Rituximab Regimen for Patients With Diffuse Large B-Cell Non-Hodgkin Lymphoma (NHL)> 60 Years or With Compromised Cardiac Status.
Phase II Dose Study of Doxil in a Dose Dense, 14 Day CDOP/Rituximab Regimen for Patients With Diffuse Large B-Cell NHL > 60 Years or With Compromised Cardiac Status

The purpose of this study is to evaluate the feasibility and tolerability of delivering a full dose, on time schedule of dose-dense CDOP-R (cyclophosphamide, doxil, vincristine, prednisone, and rituximab) in NHL.

Diffuse large B-cell lymphoma (DLBCL) is the most frequent type of non-Hodgkin's lymphoma with more than half of the patients being over the age of 60 years. Elderly patients with cancer are defined by the American Society of Clinical Oncology as a "special population" due to their disease characteristics, additional health problems, and need for aggressive supportive care strategies to reduce morbidity and mortality. The combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) remains as standard therapy for the treatment of DLBCL, but elderly patients tend to tolerate the CHOP therapy less when compared to younger patients. Cardiac toxicity, as well as decrease in blood counts, are the most common side effects in the elderly population. For these reasons, many doctors are reluctant to use standard combinations and doses of chemotherapy in the elderly for fear of increased morbidity. DLBCL in the elderly is also somewhat unique in that the elderly patients appear to have more aggressive disease and poor overall outcome. In order to maximize the tolerability of treatment and thus potentially enhance overall treatment success in this population, it is necessary to look at alternative treatments. This clinical trial is based on currently accepted standard NHL therapy (CHOP-Rituximab) in which Doxil is substituted for Adriamycin. Growth factor will be used for support of acceptable blood counts. Chemotherapy regimens that include rituximab are now the gold standard for treatment of DLBCL. If indeed, delivering full dose chemotherapy without treatment delays leads to higher remission and cure rates, then this offers a significant proportion of NHL patients who are elderly a chance for cure rather than providing treatment for comfort measures while preserving quality of life.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diffuse Large B Cell Lymphoma
  • Lymphoma, Non-Hodgkin
  • Drug: Doxil
  • Drug: Cyclophosphamide
  • Drug: Vincristine
  • Drug: Prednisone
  • Drug: Rituximab
  • Drug: Pegfilgrastim
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
27
Not Provided
Not Provided

Inclusion Criteria:

  • 60 years old and older or 18 years old and older with significant/potential cardiac morbidity
  • Diagnosis of diffuse large B cell lymphoma, Ann Arbor stage I-IV, any International Prognostic Index (IPI) score.
  • Previously untreated
  • New York Heart Association (NYHA) classification of Class III or better
  • Baseline ejection fraction (EF) > 25%
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3
  • Unless attributable to NHL: absolute neutrophil count (ANC) > 1500/uL, platelets > 100,000/uL; hemoglobin > 9.0 g/dl
  • Bilirubin < 1.5 mg/dL (unless related to lymphoma)
  • Hepatic: transaminases < 2.5 x upper limit of normal (ULN) (unless related to lymphoma)
  • Creatinine < 2.5 mg/dl (unless related to lymphoma)

Exclusion Criteria:

  • No HIV+ individuals
  • No primary central nervous system (CNS) lymphoma
  • No pregnant or lactating women
  • No serious active infection
  • History of prior malignancy within the last 5 years other than subject's original cancer diagnosis listed in inclusion criteria with the exception of curatively treated basal cell carcinoma.
Both
18 Years and older
No
Contact: Pam Nickoles, RN, BSN 410-601-0729 pnickole@lifebridgehealth.org
Contact: Judy Bosley, RN, BSN 410-601-4392 jbosley@lifebridgehealth.org
United States
 
NCT00333008
LY-012006
Not Provided
Not Provided
The Alvin and Lois Lapidus Cancer Institute
Ortho Biotech Products, L.P.
Principal Investigator: Stephen Noga, MD, PhD Sinai Hospital of Baltimore, The Alvin and Lois Lapidus Cancer Institute
The Alvin and Lois Lapidus Cancer Institute
September 2006

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