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Darbepoetin Alfa Compared With Epoetin Alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer

Primary Purpose

Anemia, Leukemia, Lymphoma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
darbepoetin alfa
epoetin alfa
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anemia focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center, UCLA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Darbepoetin alfa

Epoetin alfa

Arm Description

darbepoetin alfa administered once every two weeks at a dose of 200 ug over a 16 week treatment period.

epoetin alfa administered at 40,000 unites, once per week over a 16-week treatment period.

Outcomes

Primary Outcome Measures

Compare Efficacy of darbepoetin alfa with Epoetin Alfa as measured by the incidence of red blood cell transfusions.

Secondary Outcome Measures

Full Information

First Posted
October 3, 2003
Last Updated
July 30, 2020
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT00070382
Brief Title
Darbepoetin Alfa Compared With Epoetin Alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Amgen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Darbepoetin alfa and epoetin alfa may stimulate red blood cell production and treat anemia in patients who are receiving chemotherapy. It is not yet known whether darbepoetin alfa is more effective than epoetin alfa in treating patients with anemia. PURPOSE: Randomized phase III trial to compare the effectiveness of darbepoetin alfa with that of epoetin alfa in treating anemia in patients who are receiving chemotherapy for cancer.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous/Nonmalignant Condition, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Darbepoetin alfa
Arm Type
Experimental
Arm Description
darbepoetin alfa administered once every two weeks at a dose of 200 ug over a 16 week treatment period.
Arm Title
Epoetin alfa
Arm Type
Active Comparator
Arm Description
epoetin alfa administered at 40,000 unites, once per week over a 16-week treatment period.
Intervention Type
Drug
Intervention Name(s)
darbepoetin alfa
Intervention Description
darbepoetin alfa administered at a dose of 200ug once every 2 weeks over a 16-week treatment period
Intervention Type
Drug
Intervention Name(s)
epoetin alfa
Intervention Description
epoetin alfa administered at a dose of 40,000U once every week over a 16-week treatment period
Primary Outcome Measure Information:
Title
Compare Efficacy of darbepoetin alfa with Epoetin Alfa as measured by the incidence of red blood cell transfusions.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A. Glaspy, MD, MPH
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16710026
Citation
20030125 Study Group Trial; Glaspy J, Vadhan-Raj S, Patel R, Bosserman L, Hu E, Lloyd RE, Boccia RV, Tomita D, Rossi G. Randomized comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of chemotherapy-induced anemia: the 20030125 Study Group Trial. J Clin Oncol. 2006 May 20;24(15):2290-7. doi: 10.1200/JCO.2005.03.8570.
Results Reference
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Darbepoetin Alfa Compared With Epoetin Alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer

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