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RC05CB A Pilot, Randomized Comparison of Standard Weekly Epoetin Alfa to Every-3-Week-Epoetin Alfa and Every 3-Week Darbepoetin Alfa


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

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Trial Information

RC05CB A Pilot, Randomized Comparison of Standard Weekly Epoetin Alfa to Every-3-Week-Epoetin Alfa and Every 3-Week Darbepoetin Alfa


OBJECTIVES:

Primary

- Compare the relative efficacy of four different erythropoietic agent dosing schedules
comprising epoetin alfa or darbepoetin alfa, in terms of the proportion of patients
with chemotherapy-associated anemia who achieve a weekly and overall hematopoietic
response.

Secondary

- Compare the effect of these regimens on the mean hemoglobin increment measured weekly
from baseline to 15 weeks in patients with a baseline hemoglobin of less than or equal
to 10.5 g/dL.

- Compare the time required to achieve hemoglobin levels within the goal range 11.0-12.0
g/dL in patients treated with these regimens.

- Compare the effect of these regimens on the proportion of patients requiring red blood
cell transfusions and on the number of transfusions required.

- Compare the weekly change in hemoglobin in patients treated with these regimens.

- Compare the need for dose reduction in patients treated with these regimens.

- Compare the adverse event profiles of these regimens in these patients.

- Compare quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, unblinded, pilot study. Patients are stratified according to
severity of anemia (mild [hemoglobin ≥ 9.5 g/dL] vs severe [hemoglobin < 9.5 g/dL]),
platinum-containing regimen (yes vs no), and tumor type (nonmyeloid hematologic malignancy
vs solid tumor). Patients are randomized to 1 of 4 treatment arms.

- Arm I: Patients receive epoetin alfa subcutaneously (SC) on day 1. Treatment repeats
weekly for up to 15 courses in the absence of disease progression or unacceptable
toxicity.

- Arm II: Patients receive epoetin alfa SC on day 1 (at a higher dose than in arm I).
Treatment repeats every 3 weeks for up to 5 courses in the absence of disease
progression or unacceptable toxicity.

- Arm III: Patients receive epoetin alfa SC on day 1 (at a higher dose than in arm II).
Treatment repeats every 3 weeks for up to 5 courses in the absence of disease
progression or unacceptable toxicity.

- Arm IV: Patients receive darbepoetin alfa SC on day 1. Treatment repeats every 3 weeks
for up to 5 courses in the absence of disease progression or unacceptable toxicity.

Hemoglobin levels are monitored throughout the study on a weekly basis and before each drug
dose is administered. Drug dosing is adjusted (e.g., held, reduced, resumed at a lower dose)
as needed to maintain hemoglobin values within the desired ranges.

Quality of life is assessed at baseline and at weeks 4, 7, 10, 13, and 16.

After completion of study treatment, patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 320 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of solid tumor or nonmyeloid hematologic malignancy (e.g., plasma cell
dyscrasia or lymphoproliferative disorder)

- No nonmelanomatous skin cancer

- Hemoglobin ≤ 10.5 g/dL

- Ferritin > 20 ng/mL (i.e., not obviously iron deficient)

- Planning to receive ≥ 12 weeks of anticancer chemotherapy

- Biological therapy (e.g., hypomethylating agents, monoclonal antibodies, or
small molecule pathway inhibitors) with an individual or cumulative regimen
incidence of grade 3 or 4 anemia > 10% is considered chemotherapy for purposes
of this study

- No known anemia secondary to any of the following:

- Cyanocobalamin (vitamin B_12) or folic acid deficiency

- Gastrointestinal bleeding within the past 2 weeks

- Hemolysis

- Myelodysplastic syndromes, myeloproliferative disorders, or acute myeloid
leukemia

- No primary hematologic disorder causing chronic moderate to severe anemia (e.g.,
congenital dyserythropoietic anemia, homozygous hemoglobin S disease or compound
heterozygous sickling states, or thalassemia major)

- Carriers of these disease states allowed provided they are not anemic prior to
cancer diagnosis

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy ≥ 6 months

- Not pregnant or nursing

- No delivery of a baby of ≥ 18 weeks estimated gestational age within the past 3
months (90 days)

- Negative pregnancy test

- Fertile patients must use effective contraception

- Weight > 40.0 kg and < 150.0 kg

- No known hypersensitivity to epoetin alfa, darbepoetin alfa, mammalian-cell derived
products, or human albumin

- No uncontrolled hypertension, defined as systolic blood pressure (BP) ≥ 180 mm Hg
and/or diastolic BP ≥ 100 mm Hg, despite medical therapy

- No pulmonary emboli and/or deep vein thrombosis within the past 12 months

- Patients actively receiving warfarin for a minimum of 4 weeks are exempted from
this requirement

- Prior superficial thrombophlebitis allowed

- No cerebrovascular accident, ischemic stroke, acute coronary syndrome (e.g., unstable
angina or Q-wave or non-Q wave myocardial infarction), or other arterial or venous
thrombotic events within the past 6 months

- No history of chronic hypercoagulable disorders (e.g., activated protein C
resistance, anti-cardiolipin disorder, protein C deficiency, or protein S deficiency)

- Patients receiving anticoagulation therapy (warfarin or acetylsalicyclic acid
[aspirin] at a dose of ≥ 325 mg/day) for these conditions are eligible provided
therapy is continued during the study period

- History of previously treated seizures allowed provided the patient has been
seizure-free for a minimum of 3 months

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 1 year since prior peripheral blood stem cell, bone marrow, or cord blood
transplantation

- More than 14 days since prior red blood cell transfusion

- More than 14 days since prior major surgery, including, but not limited to, any of
the following:

- Amputation

- Invasion of a body cavity or of the central nervous system using a scalpel, saw,
or laser cutting tool

- Resection of a body part (or parts), whether solid or liquid tissue or both,
that includes ≥ 1% of a patient's preoperative weight

- The following are not considered major surgery:

- Diagnostic/therapeutic thoracentesis or paracentesis

- Diagnostic skin biopsy

- Digit or fingernail/thumbnail resection or laceration repair under local
anesthesia

- Diagnostic fat aspiration

- Otic irrigation to remove cerumen impaction

- Tympanocentesis

- Uncomplicated dental extraction

- Uncomplicated tonsillectomy

- Laser corneal remodeling for refraction purposes

- Cosmetic or therapeutic eyelid surgery

- Bone marrow aspiration and biopsy

- More than 10 weeks since prior darbepoetin alfa, epoetin alfa, or any investigational
form of erythropoietin (e.g., gene-activated erythropoietin or novel erythropoiesis
stimulating protein)

- No planned stem cell transplantation within the next 4 months (18 weeks)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Hematopoietic response (hemoglobin rise of 2 g/dL from baseline OR achievement of hemoglobin within the goal range)

Outcome Description:

the proportion of patients who exhibit a hematopoietic response (defined as Hb rise >2 g/dL from baseline or achieving Hb ≥ 11.5 g/dL, whichever occurs first, in the absence of RBC transfusions within 14 days of measurement) during the treatment period

Outcome Time Frame:

20 weeks

Principal Investigator

Charles L. Loprinzi, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000522677

NCT ID:

NCT00416624

Start Date:

May 2007

Completion Date:

June 2009

Related Keywords:

  • Anemia
  • Leukemia
  • Lymphoma
  • Lymphoproliferative Disorder
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Precancerous Condition
  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • extramedullary plasmacytoma
  • isolated plasmacytoma of bone
  • refractory multiple myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Waldenstrom macroglobulinemia
  • post-transplant lymphoproliferative disorder
  • 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 adult T-cell leukemia/lymphoma
  • AIDS-related peripheral/systemic lymphoma
  • AIDS-related primary CNS lymphoma
  • 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 cutaneous T-cell non-Hodgkin lymphoma
  • 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 mycosis fungoides/Sezary syndrome
  • stage I adult Hodgkin lymphoma
  • stage II adult Hodgkin lymphoma
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • recurrent adult Hodgkin lymphoma
  • adult grade III lymphomatoid granulomatosis
  • stage I adult Burkitt lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV adult Burkitt lymphoma
  • noncontiguous stage II adult Burkitt 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
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • contiguous stage II adult Burkitt 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
  • contiguous stage II adult immunoblastic large cell lymphoma
  • contiguous stage II adult lymphoblastic lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • contiguous stage II mantle cell lymphoma
  • contiguous stage II marginal zone lymphoma
  • contiguous stage II small lymphocytic 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
  • stage I adult immunoblastic large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage I adult lymphoblastic lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage IV adult lymphoblastic 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
  • stage I mantle cell lymphoma
  • stage I marginal zone lymphoma
  • stage III mantle cell lymphoma
  • stage III marginal zone lymphoma
  • stage IV mantle cell lymphoma
  • stage IV marginal zone lymphoma
  • stage I small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage IV small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult grade III lymphomatoid granulomatosis
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • adult acute lymphoblastic leukemia in remission
  • recurrent adult acute lymphoblastic leukemia
  • untreated adult acute lymphoblastic leukemia
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • refractory chronic lymphocytic leukemia
  • refractory hairy cell leukemia
  • progressive hairy cell leukemia, initial treatment
  • prolymphocytic leukemia
  • anemia
  • monoclonal gammopathy of undetermined significance
  • primary systemic amyloidosis
  • T-cell large granular lymphocyte leukemia
  • acute undifferentiated leukemia
  • mast cell leukemia
  • adult nasal type extranodal NK/T-cell lymphoma
  • untreated hairy cell leukemia
  • Anemia
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoproliferative Disorders
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Precancerous Conditions
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Mayo ClinicRochester, Minnesota  55905