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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


N/A
18 Years
N/A
Open (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

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Supportive Care

Principal Investigator

John A. Glaspy, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000380849

NCT ID:

NCT00090935

Start Date:

July 2004

Completion Date:

Related Keywords:

  • Anemia
  • Leukemia
  • Lymphoma
  • Lymphoproliferative Disorder
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Precancerous Condition
  • Unspecified Adult Solid Tumor, Protocol Specific
  • 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
  • stage III adult lymphoblastic 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 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 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 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
  • 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 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
  • post-transplant lymphoproliferative disorder
  • AIDS-related peripheral/systemic lymphoma
  • AIDS-related primary CNS lymphoma
  • angioimmunoblastic T-cell lymphoma
  • anaplastic large cell lymphoma
  • recurrent cutaneous T-cell non-Hodgkin 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 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
  • stage II adult Hodgkin 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
  • refractory hairy cell leukemia
  • untreated hairy cell leukemia
  • 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
  • prolymphocytic leukemia
  • adult grade III lymphomatoid granulomatosis
  • recurrent adult grade III lymphomatoid granulomatosis
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • adult acute lymphoblastic leukemia in remission
  • recurrent adult acute lymphoblastic leukemia
  • untreated 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
  • 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, UCLALos Angeles, California  90095-1781