A Randomized, Open-Label, Multicenter Study Of Darbepoetin Alfa Administered Once Every Two Weeks (Q2W) Compared With rHuEPO Administered Once Every Week (QW) For The Treatment Of Anemia In Subjects With Non-Myeloid Malignancies Receiving Multiple Chemotherapy
18 Years
N/A
Both
Anemia, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous/Nonmalignant Condition, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Randomized, Open-Label, Multicenter Study Of Darbepoetin Alfa Administered Once Every Two Weeks (Q2W) Compared With rHuEPO Administered Once Every Week (QW) For The Treatment Of Anemia In Subjects With Non-Myeloid Malignancies Receiving Multiple Chemotherapy
OBJECTIVES:
Primary
- Compare the efficacy of darbepoetin alfa vs epoetin alfa for anemia in patients with
non-myeloid malignancies receiving chemotherapy.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to screening hemoglobin concentration (less than 10.0 g/dL vs 10.0-11.0 g/dL) and
type of concurrent chemotherapy (platinum-based vs non-platinum-based). Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive darbepoetin alfa subcutaneously (SC) every other week for 12
weeks (i.e., on weeks 1, 3, 5, 7, 9, and 11).
- Arm II: Patients receive epoetin alfa SC once weekly for 12 weeks. Patients are
followed at 1 and 3 weeks .
PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this
study within 6 months.
Inclusion Criteria:
- Diagnosis of a non-myeloid malignancy
- Currently receiving or planning to receive at least 8 weeks of cyclic cytotoxic
chemotherapy
- Hemoglobin no greater than 11.0 g/dL
- 18 and over
- ECOG 0-2
- Bilirubin less than 2 times upper limit of normal (ULN)
- Creatinine less than 2 times ULN
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- More than 30 days since prior darbepoetin alfa or epoetin alfa
- More than 30 days since prior participation in investigational device or drug trials
Exclusion Criteria:
- The following diagnoses are excluded:
- Acute myeloid leukemia
- Chronic myeloid leukemia
- Acute lymphoblastic leukemia
- Hairy cell leukemia
- Burkitt's lymphoma
- Lymphoblastic lymphoma
- other primary hematologic disorder that would cause anemia (e.g., sickle cell anemia)
- angina
- congestive heart failure
- New York Heart Association class III or IV heart disease
- hypertension
- cardiac arrhythmia
- other unstable or uncontrolled disease or condition that would affect cardiac
function
- pregnant or nursing
- known seizure disorder
- known sensitivity to study agents
- clinically significant inflammatory disease (e.g., rheumatoid arthritis or Crohn's
disease)
- confirmed neutralizing antibodies to epoetin alfa
- other disorder that would preclude study compliance or giving informed consent
- other concurrent epoetin alfas
- prior randomization to this study
- other concurrent investigational agents or procedures
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Compare Efficacy of darbepoetin alfa with Epoetin Alfa as measured by the incidence of red blood cell transfusions.
Outcome Time Frame:
12 weeks
Safety Issue:
Yes
Principal Investigator
John A. Glaspy, MD, MPH
Investigator Role:
Principal Investigator
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000333213
NCT ID:
NCT00070382
Start Date:
August 2003
Completion Date:
Related Keywords:
- Anemia
- Leukemia
- Lymphoma
- Lymphoproliferative Disorder
- Multiple Myeloma and Plasma Cell Neoplasm
- Precancerous/Nonmalignant Condition
- Unspecified Adult Solid Tumor, Protocol Specific
- anemia
- unspecified adult solid tumor, protocol specific
- Waldenstrom macroglobulinemia
- monoclonal gammopathy of undetermined significance
- extramedullary plasmacytoma
- isolated plasmacytoma of bone
- refractory multiple myeloma
- primary systemic amyloidosis
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- post-transplant lymphoproliferative disorder
- angioimmunoblastic T-cell lymphoma
- anaplastic large cell lymphoma
- stage I cutaneous T-cell non-Hodgkin lymphoma
- stage II cutaneous T-cell non-Hodgkin lymphoma
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- recurrent adult T-cell leukemia/lymphoma
- stage I adult T-cell leukemia/lymphoma
- stage II adult T-cell leukemia/lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage IV adult T-cell leukemia/lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- recurrent mycosis fungoides/Sezary syndrome
- stage I mycosis fungoides/Sezary syndrome
- stage II mycosis fungoides/Sezary syndrome
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- recurrent adult Hodgkin lymphoma
- stage I adult Hodgkin lymphoma
- stage II adult Hodgkin lymphoma
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- T-cell large granular lymphocyte leukemia
- refractory chronic lymphocytic leukemia
- stage 0 chronic lymphocytic leukemia
- stage I chronic lymphocytic leukemia
- stage II chronic lymphocytic leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- prolymphocytic leukemia
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- stage I grade 1 follicular lymphoma
- stage I grade 2 follicular lymphoma
- stage I grade 3 follicular lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- contiguous stage II adult diffuse mixed cell lymphoma
- contiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- stage I adult diffuse large cell lymphoma
- stage I adult diffuse mixed cell lymphoma
- stage I adult diffuse small cleaved cell lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- contiguous stage II adult immunoblastic large cell lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- stage I adult immunoblastic large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- contiguous stage II mantle cell lymphoma
- noncontiguous stage II mantle cell lymphoma
- recurrent mantle cell lymphoma
- stage I mantle cell lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- contiguous stage II grade 1 follicular lymphoma
- contiguous stage II grade 2 follicular lymphoma
- contiguous stage II grade 3 follicular lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- Anemia
- Neoplasms
- Leukemia
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoproliferative Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Precancerous Conditions
- Lymphoma, Large-Cell, Immunoblastic
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
