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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Anemia, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous/Nonmalignant Condition, Unspecified Adult Solid Tumor, Protocol Specific

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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, UCLALos Angeles, California  90095-1781