Assessment of Early and Standard Intervention With Procrit® (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy
Phase 2
18 Years
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
Both
Anemia, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous Condition, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Assessment of Early and Standard Intervention With Procrit® (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy
OBJECTIVES:
Primary
- Determine the efficacy, in terms of maintenance of target hemoglobin and hematocrit
levels, of interval dosing with epoetin alfa in patients with anemia undergoing
chemotherapy for nonmyeloid cancer.
- Determine the safety of this drug in these patients.
Secondary
- Determine the quality of life of patients treated with this drug.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I (early intervention): Patients receive epoetin alfa subcutaneously on day 1.
Treatment repeats every 21 days for up to 5 courses.
- Arm II (standard intervention): Patients receive epoetin alfa as in arm I once their
hemoglobin level is ≤ 10.5 g/dL.
Quality of life is assessed prior to start of study treatment, at week 7 during study
treatment, and after completion of study treatment.
After completion of study treatment, patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed nonmyeloid cancer
- No history of myelodysplasia
- Baseline hemoglobin 11-12 g/dL
- No anemia due to factors other than cancer or chemotherapy (e.g., iron,
cyanocobalamin [vitamin B_12], or folate deficiencies, hemolysis, or gastrointestinal
bleeding)
- Receiving chemotherapy that meets the following criteria:
- Administered weekly OR every 3 weeks
- Must begin chemotherapy on or before the first day of study treatment
- No known, untreated CNS metastases
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-2
Life expectancy
- At least 6 months
Hematopoietic
- See Disease Characteristics
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 100,000/mm^3 (transfusion independent)
- Iron transferrin saturation > 20%
- No history of chronic hypercoagulable disorders (e.g., activated protein C
resistance, anti-cardiolipin disorder, protein C deficiency, or protein S deficiency)
Hepatic
- Bilirubin < 2.0 mg/dL
- SGPT ≤ 3 times upper limit of normal
Renal
- Creatinine ≤ 1.5 mg/dL
- No significant, uncontrolled genitourinary disease or dysfunction
Cardiovascular
- No uncontrolled cardiac arrhythmia in the past 6 months
- No uncontrolled hypertension
- No deep vein thrombosis, ischemic stroke, or other arterial or venous thrombotic
events
- Superficial thromboses allowed
- No other significant, uncontrolled cardiovascular disease or dysfunction
Pulmonary
- No significant, uncontrolled pulmonary disease or dysfunction
- No pulmonary emboli
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No infection requiring hospitalization or antibiotics in the past 14 days
- No known hypersensitivity to mammalian cell-derived products or to human albumin
- No new onset (in the past 3 months) poorly controlled seizures
- No other active malignancy except basal cell carcinoma or carcinoma in situ
- Not an employee of the investigator or study center or family members of the employee
or the investigator
- No significant, uncontrolled neurological, endocrine, or gastrointestinal disease or
dysfunction
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Chemotherapy
- More than 3 months since prior erythropoietic agent (e.g., epoetin alfa, darbepoetin
alfa, or gene-activated erythropoietin)
- More than 4 weeks since prior packed red blood cell transfusion
- No concurrent stem cell harvest of bone marrow
- No concurrent interleukin-11
- No other concurrent erythropoietic agent
Chemotherapy
- See Disease Characteristics
- No concurrent high-dose chemotherapy with stem cell transplantation
Radiotherapy
- No concurrent nonpalliative radiotherapy
Surgery
- More than 2 weeks since prior major surgery
Other
- At least 1 month since prior investigational agents or devices
- No concurrent high-dose IV iron supplementation
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Efficacy
Outcome Time Frame:
7 weeks
Safety Issue:
No
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:
CDR0000449950
NCT ID:
NCT00255749
Start Date:
August 2005
Completion Date:
Related Keywords:
- Anemia
- Leukemia
- Lymphoma
- Lymphoproliferative Disorder
- Multiple Myeloma and Plasma Cell Neoplasm
- Precancerous Condition
- Unspecified Adult Solid Tumor, Protocol Specific
- adult acute lymphoblastic leukemia in remission
- progressive hairy cell leukemia, initial treatment
- stage 0 chronic lymphocytic leukemia
- anemia
- extramedullary plasmacytoma
- isolated plasmacytoma of bone
- refractory multiple myeloma
- monoclonal gammopathy of undetermined significance
- primary systemic amyloidosis
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- AIDS-related peripheral/systemic lymphoma
- AIDS-related primary CNS lymphoma
- anaplastic large cell lymphoma
- angioimmunoblastic T-cell lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell 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 Hodgkin lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent adult T-cell leukemia/lymphoma
- recurrent cutaneous T-cell non-Hodgkin 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 mycosis fungoides/Sezary syndrome
- recurrent small lymphocytic lymphoma
- splenic marginal zone lymphoma
- stage III adult Burkitt lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult Hodgkin lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III mantle cell lymphoma
- stage III marginal zone lymphoma
- stage III mycosis fungoides/Sezary syndrome
- stage III small lymphocytic lymphoma
- stage IV adult Burkitt lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult Hodgkin lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV adult T-cell leukemia/lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV mantle cell lymphoma
- stage IV marginal zone lymphoma
- stage IV mycosis fungoides/Sezary syndrome
- stage IV small lymphocytic lymphoma
- Waldenström macroglobulinemia
- 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
- 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
- post-transplant lymphoproliferative disorder
- stage I adult Burkitt lymphoma
- stage I adult diffuse large cell lymphoma
- stage I adult diffuse mixed cell lymphoma
- stage I adult diffuse small cleaved cell lymphoma
- stage I adult Hodgkin lymphoma
- stage I adult immunoblastic large cell lymphoma
- stage I adult lymphoblastic lymphoma
- stage I adult T-cell leukemia/lymphoma
- stage I cutaneous T-cell non-Hodgkin lymphoma
- stage I grade 1 follicular lymphoma
- stage I grade 2 follicular lymphoma
- stage I grade 3 follicular lymphoma
- stage I mantle cell lymphoma
- stage I marginal zone lymphoma
- stage I small lymphocytic lymphoma
- stage II adult Hodgkin lymphoma
- stage II adult T-cell leukemia/lymphoma
- stage II cutaneous T-cell non-Hodgkin lymphoma
- stage I mycosis fungoides/Sezary syndrome
- stage II mycosis fungoides/Sezary syndrome
- recurrent adult acute lymphoblastic leukemia
- refractory chronic lymphocytic leukemia
- stage I chronic lymphocytic leukemia
- stage II chronic lymphocytic leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- refractory hairy cell leukemia
- prolymphocytic leukemia
- unspecified adult solid tumor, protocol specific
- T-cell large granular lymphocyte leukemia
- 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 at UCLA | Los Angeles, California 90095-1781 |
