Epoetin Alfa in Treating Cancer-Related Anemia in Patients With Non-Myeloid Cancer Who Are Not Currently Receiving Chemotherapy or Radiation Therapy
Recruitment status was Active, not recruiting
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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 |
|---|---|
|
Anemia Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Precancerous Condition Unspecified Adult Solid Tumor, Protocol Specific |
Biological: epoetin alfa |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Supportive Care |
| 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 |
| Study Start Date: | July 2004 |
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 |
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| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-6996 | |
| Study Chair: | John A. Glaspy, MD, MPH | Jonsson Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00090935 History of Changes |
| Other Study ID Numbers: | CDR0000380849, UCLA-040304801, ORTHO-PR03-27-002 |
| Study First Received: | September 7, 2004 |
| Last Updated: | February 19, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
anemia unspecified adult solid tumor, protocol specific Waldenström 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 |
Additional relevant MeSH terms:
|
Anemia Neoplasms Leukemia Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Precancerous Conditions Lymphoma, Large-Cell, Immunoblastic Hematologic Diseases Neoplasms by Histologic Type Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hemorrhagic Disorders Epoetin Alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013