Clinical trial NCT00070382: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2003-10-07
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Compare Efficacy of darbepoetin alfa with Epoetin Alfa as measured by the incidence of red blood cell transfusions.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center, UCLA
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: John A. Glaspy, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.