A Study to Assess the Response Rate of PROCRIT (Epoetin Alfa) Given at a Dose of 40,000 Units Once a Week to Cancer Patients With Anemia Who Are Not Receiving Chemotherapy.

Condition(s) targeted: Neoplasms; Anemia

Intervention: Epoetin Alfa (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Ortho Biotech Products, L.P.

Official(s) and/or principal investigator(s):
Ortho Biotech Products, L.P. Clinical Trial, Study Director, Affiliation: Ortho Biotech, Inc.

The purpose of this study is to evaluate the effectiveness and safety of PROCRIT (Epoetin alfa) administered at 40,000 Units weekly in cancer patients that are not receiving chemotherapy or radiation therapy.

Official title: A Pilot Study to Evaluate the Response Rate of PROCRIT (Epoetin Alfa) at 40,000 Units Once Weekly in Anemic Cancer Patients Not Receiving Chemotherapy

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Hematologic response in terms of hemoglobin and transfusion requirements where hemoglobin response is characterized as minor > 1g/dL Hb increase or major > 2g/dL Hb increase.

Secondary outcome: Secondary efficacy variables will include the effects of PROCRIT (Epoetin alfa) on transfusion requirements and on Quality of Life as measured by the Linear Analog Scale Assessment (LASA) tool.

Detailed description: This is an open-label (both the researcher and the patient in the study know the treatment that is being given), non-randomized, multi-center pilot study with the objective to investigate the efficacy of PROCRIT (Epoetin alfa) with regard to hematopoietic response when administered at 40,000 Units subcutaneously (under the skin) once per week in anemic patients with cancer not receiving chemotherapy or radiation therapy. Hematological laboratory tests (hemoglobin and hematocrit), vital signs (blood pressure) and occurrence and severity of adverse events will be assessed throughout the study.

Patients will receive a PROCRIT (Epoetin alfa) injection (40,000 Units per injection) under the skin once every week for a maximum of 13 weeks. Doses may be reduced depending on the patients' hemoglobin level.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Histologically confirmed diagnosis of non-myeloid malignancy

- Baseline hemoglobin value of less than or equal to 11 g/dL unrelated to transfusion

- Patients must not be receiving or planning to receive chemotherapy or radiotherapy

within the 16-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

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

A Pilot Study to Evaluate the Response Rate of PROCRIT (Epoetin alfa) at 40,000 Units Once Weekly in Anemic Cancer Patients Not Receiving Chemotherapy or Radiation Therapy

For FDA Approved Product labeling, refer to the following link:http://www.accessdata.fda.gov/scripts/cder/drugsatfda/

Additional information is provided at the following link;http://dailymed.nlm.nih.gov/dailymed/about.cfm

For FDA Safety Alerts and Recalls refer to the following link:www.fda.gov/MEDWATCH/safety.htm

Starting date: May 2003
Ending date: March 2004
Last updated: December 4, 2007