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A Pilot Study to Evaluate the Response Rate of Epoetin Alfa (PROCRIT) at 80,000 Units Every Three Weeks in Anemic Patients With Cancer Not Receiving Chemotherapy or Radiation Therapy


Phase 3
18 Years
N/A
Not Enrolling
Both
Anemia, Neoplasms

Thank you

Trial Information

A Pilot Study to Evaluate the Response Rate of Epoetin Alfa (PROCRIT) at 80,000 Units Every Three Weeks in Anemic Patients With Cancer Not Receiving Chemotherapy or Radiation Therapy


The current approved dosage for epoetin alfa is 40,000 Units once per week with an
escalation to 60,000 Units once per week if the response is inadequate after four weeks of
treatment at 40,000 Units. This dosing scheme, while proven to be efficacious, is often
inconvenient for both patients and medical personnel. This is an open-label, non-randomized,
multi-center pilot study with the objective to investigate the efficacy of epoetin alfa
(PROCRIT®) with regard to hematopoietic response when administered at 80,000 Units
subcutaneously every three weeks in anemic patients with cancer not receiving chemotherapy
or radiation therapy. Patients will receive two epoetin alfa injections (40,000 Units per
injection) under the skin once every three weeks for a maximum of 13 weeks, totalling a
maximum of four treatments. Doses may be reduced depending on the patients' hemoglobin
level.


Inclusion Criteria:



- Histologically confirmed diagnosis of non-myeloid malignancy

- Baseline hemoglobin value of <= 11 g/dL unrelated to transfusion

- Patients must not be receiving or planning to receive chemotherapy or radiotherapy
within the 13-week study period. However, patients receiving hormonal therapy or
non-myelosuppressive therapies are allowable

- Female patients with reproductive potential must have a negative serum pregnancy test
at screening

- Patients must have signed an informed consent

Exclusion Criteria:

- Uncontrolled hypertension

- History (within 6 months) of uncontrolled cardiac arrhythmias, or history of
pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous
thrombotic events (excluding superficial thromboses), or known history of chronic
coagulation disorder

- Transfusion within 28 days prior to first dose

- Planned chemotherapy or radiation during study and no prior chemotherapy within 8
weeks or radiation within 4 weeks of study entry

- No prior treatment with Epoetin alfa or any other erythropoietic agent within the
previous two months

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percent of patients that achieved a hematopoietic response, defined as a Hb increase >= 2 g/dL and/or Hb = 12 g/dL during the study independent of transfusion within 28 days

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:

CR003223

NCT ID:

NCT00210587

Start Date:

February 2005

Completion Date:

December 2005

Related Keywords:

  • Anemia
  • Neoplasms
  • Anemia
  • Neoplasms
  • hemoglobin level
  • Anemia
  • Neoplasms

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