Know Cancer

or
forgot password

A Pilot Study to Evaluate the Safety and Efficacy of PROCRIT (Epoetin Alfa) 80,000 Units Once Every Four Weeks (Q4W) vs. 40,000 Units Once Every Two Weeks (Q2W) in Cancer Subjects With Non-Chemotherapy Anemia (NCA)


Phase 2
18 Years
N/A
Not Enrolling
Both
Anemia, Cancer, Epoetin Alfa

Thank you

Trial Information

A Pilot Study to Evaluate the Safety and Efficacy of PROCRIT (Epoetin Alfa) 80,000 Units Once Every Four Weeks (Q4W) vs. 40,000 Units Once Every Two Weeks (Q2W) in Cancer Subjects With Non-Chemotherapy Anemia (NCA)


Epoetin alfa is an analogue (has the identical amino acid sequence) of erythropoetin, a
hormone secreted by kidneys known to stimulate red blood cell production. Although epoetin
alfa has been known to be effective in treatment of anemia associated with cancer
chemotherapy, there are no specific formal guidelines on the use of epoetin alfa for the
treatment of anemia in cancer patients not receiving chemotherapy or radiation therapy.
Several prospective clinical trials investigating the efficacy of epoetin alfa in
cancer-associated anemia included groups of patients not receiving chemotherapy where it was
demonstrated that the use of epoetin alfa in this population was safe and effective in
increasing hemoglobin (Hb) levels and reducing transfusion requirements. The optimal dosing
regimen of epoetin alfa in cancer patients not receiving chemotherapy or radiation therapy
remains unclear.

This 17-week study is a prospective, randomized, open-label, multi-center study to assess
the safety and effectiveness of epoetin alfa in anemic patients with cancer not receiving
chemotherapy or radiation therapy. Eligible patients with hemoglobin level <= 11 g/dL will
receive epoetin alfa 40,000 U once every 2 weeks for 15 weeks or 80,000 U once every 4 weeks
for 13 weeks. The study hypothesis are that there are no long-term safety concerns of
epoetin alfa administered at these two dosing regimens and that both dosing regimens are
equally effective in this patient population. Eligible patients with hemoglobin levels <= 11
g/dL will receive epoetin alfa 40,000 U once every 2 weeks for 15 weeks or 80,000 U once
every 4 weeks for 13 weeks.


Inclusion Criteria:



- Patients must have "Active non-myeloid cancer malignancy" or incurable cancer with a
life expectancy of 6 months or more

- Patients may also have had cancer treatment within the past 2 years but no
chemotherapy or radiation therapy within the past 8 weeks prior to enrollment

- must be >= 18 years of age and must not be receiving or planning to receive cytotoxic
chemotherapy or external beam radiotherapy during the study period

- must have a baseline Hb <= 11 g/dL.

- Patients with reproductive potential must be practicing an effective method of birth
control and women cannot be pregnant or breast-feeding during the study period

- Patients must be able to comply with all requirements of the study (i.e. study visit
schedules) and patients (or their legally authorized representatives) must have
signed an informed consent document indicating that they understand the purpose of
and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

- Patients receiving or planning to receive chemotherapy or radiation therapy within 8
weeks of study entry

- Anemia due to factors other than cancer

- Previous treatment with epoetin alfa or any form of erythropoietin during the
previous 1 month or received an experimental drug or device within past 30 days

- Known hypersensitivity to mammalian-cell derived products or to human albumin

- Untreated known central nervous system (CNS) metastases

- Uncontrolled or clinically severe disease of the pulmonary, cardiovascular,
endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to
underlying malignancy or chemotherapy

- History of (within 12 months) deep venous thrombosis (DVT), pulmonary embolus (PE),
or other venous thrombotic events, cerebrovascular accident (CVA), transient ischemic
attack (TIA), Acute Coronary Syndrome (ACS) [unstable angina, myocardial infarction
(MI)], or other arterial thrombosis

- Currently receiving therapeutic or prophylactic anticoagulants

- Transfusion of packed red blood cells within 28 days prior to the first dose of study
drug, or planned stem cell harvest of bone marrow or high dose chemotherapy with stem
cell transplant during study duration.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary efficacy endpoint will be hematopoietic response, defined as >= 1 g/dL rise in hemoglobin from baseline.

Principal Investigator

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Authority:

United States: Food and Drug Administration

Study ID:

CR010540

NCT ID:

NCT00306267

Start Date:

March 2006

Completion Date:

May 2007

Related Keywords:

  • Anemia
  • Cancer
  • Epoetin Alfa
  • Anemia
  • non-chemotherapy-induced
  • non-radiation therapy-induced
  • cancer
  • non-myeloid
  • Anemia

Name

Location