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Epoetin Alfa in Treating Cancer-Related Anemia in Patients With Non-Myeloid Cancer Who Are Not Currently Receiving Chemotherapy or Radiation Therapy
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00090935
  Purpose

RATIONALE: Epoetin alfa may stimulate red blood cell production and treat anemia in patients with non-myeloid cancer.

PURPOSE: This clinical trial is studying how well epoetin alfa works in treating cancer-related anemia in patients with non-myeloid cancer who are not currently receiving chemotherapy or radiation therapy.


Condition Intervention
Cancer-Related Problem/Condition
Leukemia
Lymphoma
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Precancerous/Nonmalignant Condition
Unspecified Adult Solid Tumor, Protocol Specific
Drug: epoetin alfa

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Anemia Cancer Fungal Infections Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma
Drug Information available for: Epoetin alfa Erythropoietin
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Open Label
Official Title: A Pilot Study To Evaluate The Response Rate Of Procrit (Epoetin Alfa) At 60,000 Units Every Two Weeks In Anemic Patients With Cancer Not Receiving Chemotherapy Or Radiation Therapy

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 2004
Detailed Description:

OBJECTIVES:

Primary

  • Determine the efficacy of epoetin alfa, in terms of hematologic response, in patients with non-myeloid malignancy and cancer-related anemia who are not currently receiving chemotherapy or radiotherapy.

Secondary

  • Determine time to hematologic response in patients treated with this drug.
  • Determine transfusion requirements in patients treated with this drug.
  • Determine the safety and tolerability of this drug in these patients.
  • Determine the quality of life of patients treated with this drug.

OUTLINE: This is an open-label, nonrandomized, pilot, multicenter study.

Patients receive epoetin alfa subcutaneously on day 1 of weeks 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then at weeks 5, 9, 13, and 17.

Patients are followed for 4 weeks.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-myeloid malignancy
  • Cancer-related anemia (hemoglobin ≤ 11 g/dL for males OR ≤ 10 g/dL for females) AND meets one of the following criteria:

    • Post adjuvant chemotherapy
    • Post radiotherapy
    • Metastatic disease and post chemotherapy or not receiving chemotherapy
    • Receiving hormonal therapy or androgen-deprivation therapy
    • Receiving immunotherapy (i.e., interleukin-2 or interferon) or non-myelosuppressive therapy, including any of the following:

      • Monoclonal antibody infusions
      • Antiangiogenesis inhibitors
      • Signal transduction inhibitors
    • No prior cancer therapy
  • No anemia due to factors other than cancer or chemotherapy (e.g., iron, B_12, or folate deficiencies; hemolysis; or gastrointestinal bleeding)
  • No history of myelodysplasia
  • No untreated CNS metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 4 months

Hematopoietic

  • See Disease Characteristics
  • Absolute neutrophil count ≥ 1,000/mm^3*
  • Platelet count ≥ 100,000/mm^3* NOTE: *No transfusion within 28 days of obtaining lab values

Hepatic

  • Bilirubin ≤ 2.0 mg/dL
  • SGPT ≤ 3 times upper limit of normal

Renal

  • Creatinine ≤ 1.5 mg/dL

Cardiovascular

  • No uncontrolled hypertension
  • No uncontrolled cardiac arrhythmia within the past 6 months
  • No clinically significant, uncontrolled cardiovascular disease or dysfunction not attributable to underlying malignancy or chemotherapy
  • No thrombosis within the past 6 months

Pulmonary

  • No clinically significant, uncontrolled pulmonary disease or dysfunction not attributable to underlying malignancy or chemotherapy
  • No pulmonary embolism within the past 6 months

Neurologic

  • No clinically significant, uncontrolled neurologic disease or dysfunction not attributable to underlying malignancy or chemotherapy
  • No new-onset (within the past 3 months) or poorly controlled seizures

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No major infection requiring hospitalization and antibiotics within the past 2 weeks
  • No known hypersensitivity to mammalian cell-derived products or human albumin
  • No clinically significant, uncontrolled endocrine, genitourinary, or gastrointestinal disease or dysfunction not attributable to underlying malignancy or chemotherapy
  • No other active malignancy except basal cell carcinoma in situ

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • More than 2 months since prior epoetin alfa or any other erythropoietic agents (e.g., darbepoetin alfa or gene-activated erythropoietin)
  • No concurrent interleukin-11
  • No concurrent stem cell harvest of bone marrow
  • No concurrent high-dose chemotherapy with stem cell transplantation
  • No other concurrent erythropoietic agents

Chemotherapy

  • See Disease Characteristics
  • See Biologic therapy
  • More than 8 weeks since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics

Radiotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy to > 25% of bone marrow reserve
  • No concurrent radiotherapy

Surgery

  • More than 14 days since prior major surgery

Other

  • More than 28 days since prior platelet or packed red blood cell transfusion
  • More than 30 days since prior experimental drugs or devices
  • No other concurrent experimental drugs
  • No other concurrent anti-anemia medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00090935

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-6996
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: John A. Glaspy, MD, MPH Jonsson Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000380849, UCLA-040304801, ORTHO-PR03-27-002
Study First Received: September 7, 2004
Last Updated: November 16, 2008
ClinicalTrials.gov Identifier: NCT00090935  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
anemia
unspecified adult solid tumor, protocol specific
Waldenstrom macroglobulinemia
monoclonal gammopathy of undetermined significance
isolated plasmacytoma of bone
extramedullary plasmacytoma
refractory multiple myeloma
primary systemic amyloidosis
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
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 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 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

Study placed in the following topic categories:
Epoetin Alfa
Sezary syndrome
Hodgkin lymphoma, adult
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Lymphoma, large-cell, immunoblastic
Central nervous system lymphoma, primary
Lymphomatoid granulomatosis
Mycoses
Leukemia, Prolymphocytic
Hemorrhagic Disorders
Multiple myeloma
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large-Cell, Anaplastic
Hodgkin Disease
Chronic lymphocytic leukemia
Lymphoma, Large B-Cell, Diffuse
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hematologic Diseases
Leukemia, B-cell, chronic
Blood Coagulation Disorders
Multiple Myeloma
Waldenstrom Macroglobulinemia
Plasmacytoma
B-cell lymphomas
Leukemia, T-Cell
Anaplastic large cell lymphoma
Lymphoma, Non-Hodgkin
Hairy cell leukemia

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Hematinics
Therapeutic Uses
Hematologic Agents
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009