A Phase II Study Of Rituximab-CHOP With Pegylated Liposomal Doxorubicin In Patients Older Than 60 Years Of Age With Untreated Aggressive B-Cell Non-Hodgkin's Lymphoma
61 Years
N/A
Both
Lymphoma
Trial Information
A Phase II Study Of Rituximab-CHOP With Pegylated Liposomal Doxorubicin In Patients Older Than 60 Years Of Age With Untreated Aggressive B-Cell Non-Hodgkin's Lymphoma
OBJECTIVES:
Primary
- Determine the clinical response rate in older patients with previously untreated
aggressive diffuse large B-cell stage II-IV lymphoma treated with rituximab,
cyclophosphamide, pegylated doxorubicin hydrochloride liposome (HCl), vincristine, and
prednisone.
- Determine the cardiotoxicity and myelosuppression of this regimen in these patients.
Secondary
- Determine disease-free survival and overall survival of patients treated with this
regimen.
OUTLINE: This is a multicenter study.
Patients receive rituximab intravenous (IV), cyclophosphamide IV over 1-1½ hours, pegylated
doxorubicin HCl liposome IV over 1 hour, and vincristine IV on day 1, and oral prednisone on
days 1-5. Patients also receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning
on day 6 and continuing until blood counts recover OR pegfilgrastim SC once on day 6 (24
hours after the completion of chemotherapy). Treatment repeats every 21 days for up to 8
courses in the absence of unacceptable toxicity, disease progression, active hepatitis B
virus infection, or hepatitis. Patients with no response OR who achieve less than a partial
response after 4 courses are removed from the study.
Patients are followed at 1 month, every 3 months for 1 year, every 4 months for 1 year, and
then every 6 months thereafter.
PROJECTED ACCRUAL: A maximum of 80 patients will be accrued for this study within 27 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed diffuse large B-cell lymphoma
- Stage II, III, or IV disease
- Previously untreated disease
- Measurable or evaluable disease
- No primary central nervous system (CNS) lymphoma or follicular B-cell lymphoma
PATIENT CHARACTERISTICS:
Age
- 61 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 1,000/mm^3*
- Platelet count > 100,000/mm^3* NOTE: * Unless due to lymphoma-related hypersplenism
or bone marrow infiltration
Hepatic
- Bilirubin < 2 mg/dL
- Hepatitis B surface antigen negative
- Hepatitis B core antibody negative
- Hepatitis C Virus antibody negative
Renal
- Creatinine < 2 mg/dL
Cardiovascular
- left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or ple gated
acquisition (MUGA) scan
- No uncontrolled hypertension or cardiac symptoms
- Cardiologist consultation required for patients with stage A cardiac failure or any
of the following known heart diseases:
- Diastolic dysfunction
- Prior coronary artery bypass graft
- Prior percutaneous transluminal coronary angioplasty
- Prior stent insertion
- Prior radiotherapy to the chest
- No myocardial infarction within the past 6 months
- No New York Heart Association class II-IV heart failure
- No uncontrolled angina
- No severe uncontrolled ventricular arrhythmias
- No clinically significant pericardial disease
- No acute ischemic or active conduction system abnormality by electrocardiogram (EKG)
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No psychiatric illness that would preclude study compliance or giving informed
consent
- No other major life-threatening illness that would preclude study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- See Cardiovascular
Surgery
- See Cardiovascular
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease response (complete, complete unconfirmed, and partial responses) after courses 4 and 8
Outcome Time Frame:
Up to 24 weeks (8 cycles of 21 days)
Safety Issue:
No
Principal Investigator
Maria A. Rodriguez, MD
Investigator Role:
Study Chair
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000407533
NCT ID:
NCT00101010
Start Date:
September 2005
Completion Date:
Related Keywords:
- Lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- stage III adult diffuse large cell lymphoma
- stage IV adult diffuse large cell lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
Name | Location |
|---|---|
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
| Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
| Hembree Mercy Cancer Center at St. Edward Mercy Medical Center | Ft. Smith, Arkansas 72903 |
| University of Texas M.D. Anderson CCOP Research Base | Houston, Texas 77030-4009 |
| Hematology Oncology Associates of Central New York, PC - Northeast Center | East Syracuse, New York 13057-4510 |
