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Epoetin Alfa

PROCRIT 40 000 IU QW Epoetin alpha (PROCRIT) 40 000 IU every week (QW) for 18 weeks (IV or SC)

Placebo Equivalent volume to PROCRIT (1 mL) administered (QW) for 18 weeks (IV or SC)

Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (IV or SC)

PROCRIT 40,000 IU QW

Equivalent volume to PROCRIT (1 mL) administered (QW) for 18 weeks (IV or SC)

Placebo

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

The purpose of this study is to evaluate the neuroprotective effect of PROCRIT (epoetin alfa, a glycoprotein that stimulates red blood cell production) versus placebo in patients with cancer who develop chemotherapy-induced peripheral neuropathy due to combination Taxane and Platinum-Based treatment.

Peripheral neuropathy is a debilitating disease of the nerves which can be a dose-limiting toxicity of chemotherapeutic agents. The symptoms of peripheral neuropathy can lead to considerable patient distress and discomfort, discontinuation of chemotherapy, and limitations regarding the selection of future chemotherapeutic regimens. Symptoms such as numbness, weakness, burning pain (especially at night), and loss of reflexes may take months before they improve and permanent deficits may remain. Epoetin alfa, already used in the treatment of chemotherapy-induced anemia, has been shown to have neuroprotective effects in preclinical studies. The purpose of this randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), placebo-controlled study is to evaluate the neuroprotective effect of PROCRIT (epoetin alfa) administered once every week in patients with cancer who develop chemotherapy-induced peripheral neuropathy due to treatment with combination Taxane and Platinum-Based chemotherapy. Patients will receive injections subcutaneously or intravenously of either epoetin alfa or placebo once weekly for up to 18 weeks. Doses may be adjusted in the range of 20,000 to 60,000 Units once a week, depending on the patient's hemoglobin levels. Safety evaluations will be conducted throughout the study at specified intervals and will consist of assessment of laboratory tests (Hemoglobin level, Complete Blood Count (CBC), Blood Chemistries), vital signs, physical examinations and occurrence and severity of adverse events. In addition, the occurrence of anti-erythropoietin antibodies at baseline and study completion/early withdrawal will be evaluated in patients who received PROCRIT (Epoetin alfa) after database lock and unblinding has occurred. The primary measure of effectiveness is the change at Week 12 in the National Cancer Institute Common Toxicity Criteria (NCI CTC) neuropathy score. The study hypothesis is that epoetin alfa will be more effective in the treatment of chemotherapy-induced peripheral neuropathy than placebo as measured at Week 12 by the National Cancer Institute Common Toxicity Criteria (NCI CTC) neuropathy score. Patients will receive injections subcutaneously (SC, under the skin) or intravenously (IV, in a vein) of either epoetin alfa or placebo once weekly for up to 18 weeks. Doses may be adjusted depending on the patient's hemoglobin levels to the maximum 60,000 Units once a week. The minimum dose can be 20,000 Units once a week.

A Study to Investigate the Neuroprotective Effect of PROCRIT (Epoetin Alfa) Versus Placebo in Cancer Patients Who Develop Chemotherapy-induced Peripheral Neuropathy

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 18 Week Pilot Study to Investigate the Neuroprotective Effect of PROCRIT (Epoetin Alfa) on the Development of Peripheral Neuropathy in Patients Receiving Combination Taxane and Platinum-Based Chemotherapy for Cancer

NCI CTC neuropathy: a descriptive terminology used to grade the severity of AEs in cancer subjects on a 0-5 scale. A higher score indicates worse peripheral neuropathy.

Ortho Biotech Clinical Affairs, L.L.C.

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

Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)

Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

No formal analysis was conducted due to early termination

Vice President

MITT(Modified intent to treat)all randomized subjects that received at least one dose and had at least one post-baseline neuropathy assessment.

The Number of Patients Who Developed Peripheral Sensory Neuropathy (National Cancer Institute Common Toxicity Criteria (NCI CTC) Score >= 1) at Week 12.

The Number of Patients Who Developed Peripheral Sensory Neuropathy (National Cancer Institute Common Toxicity Criteria (NCI CTC) Score >= 2) at Week 12.

Overall Study

Blood and Lymph Conditions

Anemia

Hematologic Diseases

epoetin alfa

The purpose of this study is to compare the efficacy of epoetin alfa (PROCRITÂ®) administered subcutaneously (sc) once every week (qw) vs. no epoetin alfa (PROCRITÂ®) treatment in patients with cancer who are anemic.

The purpose of this study is to evaluate hematologic response in patients receiving epoetin alfa (PROCRIT®) therapy for persistent chemotherapy-induced myelosuppression (anemia) after completion of chemotherapy administration as compared to patients who do not receive weekly epoetin alfa (PROCRIT®) immediately after cessation of chemotherapy. Further, the duration of treatment necessary to achieve these endpoints will be studied. A No/Delayed epoetin alfa (PROCRIT®) treatment control (whereby patients in the control group will receive epoetin alfa (PROCRIT®) if their Hb decreases to \< 10g/dL during the study) will be used to establish the frequency and magnitude of changes in clinical end points that may occur when epoetin alfa (PROCRIT®) treatment is not continued (or started) for patients with residual myelosuppression after chemotherapy administration has ended. A 2:1 randomization will be used to give every patient a greater chance to receive immediate treatment (66.6% epoetin alfa (PROCRIT®) treatment vs. 33.3% No/Delayed epoetin alfa (PROCRIT®) treatment). The study will be powered to show differences between the two groups in hematologic response.

In this study, the hematologic response is defined as the proportion of patients who are transfusion-free and are able to maintain their mean Hb level at \>= 11 g/dL during the study without a Hb drop to \<= 10 g/dL and/or transfusion.

The study hypothesis was that immediate epoetin alfa (PROCRIT®) treatment would be more effective in treatment of anemia than No/Delayed epoetin alfa (PROCRIT®) treatment in patients with cancer and persistent chemotherapy-induced anemia. Patients will be randomized 2:1 to receive epoetin alf or no epoetin treatment. The starting dose will be 40,000 Units weekly (QW) or the dose they were on prior to the study (30,000-60,000 Units QW). If the Hb level decreases to \<= 10 g/dL, PROCRIT will be initiated at a dose of 40,000 Units QW.

The Duration Study

An Open Label Randomized Study To Evaluate The Response Rate Of Epoetin Alfa (PROCRIT�) Versus No/Delayed PROCRIT Treatment In Patients With Cancer And Persistent Chemotherapy-Induced Myelosuppression (Anemia)

Ortho Biotech Products, L.P.

Darbepoetin alfa

Epoetin alfa and Darbepoetin alfa

Ortho Biotech Products, L.P. Clinical Trial

The purpose of this study is to compare hemoglobin (Hgb) response rates between epoetin alfa (PROCRIT; 40,000 Units (U) SC weekly) and darbepoetin alfa (ARANESP; 200 mcg every other week) in anemic cancer patients receiving chemotherapy.

Chemotherapy related anemia occurs in a majority of cancer patients and can cause impaired treatment outcomes, increased treatment-related complications and altered quality of life. Epoetin alfa administered on a weekly dosing schedule of 40,000 Units subcutaneously (\[SC\], under the skin) with dose adjustments based on hematologic response produces significant improvement in hemoglobin levels, decreased transfusion frequency and improved quality of life. It is unknown if the recently developed agent, darbepoetin alfa, administered on an every other week fixed dose will produce similar improvements in hematologic and quality of life outcomes. Thus, further randomization studies are warranted utilizing once weekly dosing (QW) of Epoetin alfa compared to once every other week (Q2W) darbepoetin alfa. Patients will receive study medications for up to 16 weeks.Safety \& efficacy evaluations will be performed at specified intervals throughout the study.The study hypothesis is that the Week 5 hemoglobin response rate in the Epoetin alfa group is better than that in the Darbepoetin alfa group. The starting dose for study drug is either Epoetin alfa (PROCRIT) 40,000 Units SC QW or Darbepoetin alfa (ARANESP) 200 mcg SC Q2W. Doses may be adjusted depending on the patient's hemoglobin levels up a maximum of 60,000 IU SC QW Epoetin alfa or 300 mcg SC Q2W Darbepoetin alfa.

Hematologic Response of Epoetin Alfa (PROCRIT) Versus Darbepoetin Alfa (ARANESP) in Chemotherapy Induced Anemia

A Randomized, Open-Label Study Of Epoetin Alfa (PROCRIT) Versus Darbepoetin Alfa (ARANESP) To Evaluate Hematologic Response Rate In Anemic Cancer Patients Receiving Chemotherapy

PROCRIT (Epoetin alfa)

The purpose of this study is to evaluate the safety and efficacy of PROCRIT (Epoetin alfa) when administered at 120,000 Units once every three weeks by comparing early dosing (Hb 11g/dL-12g/dL) vs. standard dosing (Hb\< 11g/dL).

This is a randomized, open-label, multi-center study. Eligible patients will be identified during the screening phase. After randomization, the Treatment Phase will start at the Day 1, Week 1 visit. The entire study period will be up to 22 weeks, with the screening phase lasting up to two weeks, treatment for a maximum of 16 weeks, and safety follow-up for four weeks. The primary objective of this study is to obtain efficacy and safety data regarding PROCRIT (Epoetin alfa) administered at 120,000 units subcutaneously (sc) once every three weeks (q3w) in 2 patient groups with cancer and anemia receiving chemotherapy:

1. Early Intervention Group: PROCRIT (Epoetin alfa) treatment started at patient hemoglobin (Hb) \>= 11.0 g/dL to \<= 12.0 g/dL and
2. Standard Intervention Group: PROCRIT (Epoetin alfa) treatment started once patient hemoglobin drops to \< 11 g/dL or has a Hb \<11.0 g/dL at study entry.

For safety monitoring, all patients will be followed for adverse events, hemoglobin (Hb), hematocrit (Hct), blood chemistries and blood pressure measurements throughout the study. All eligible patients with hemoglobin \< 12.0 g/dL will be randomized to receive Epoetin alfa injections (120,000 Units ) under the skin every 3 weeks for a maximum of 16 treatment weeks. Doses may be adjusted depending on the patients hemoglobin levels.

Early and Standard Intervention With 120,000 Units of PROCRIT (Epoetin Alfa) Every Three Weeks in Patients Receiving Chemotherapy

Assessment of Early and Standard Intervention With PROCRIT (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy.

The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa (PROCRITÂ®) administered 80,000 Units every three weeks in cancer patients that are 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.

An Efficacy and Safety Study for Epoetin Alfa (PROCRIT) in Cancer Patients Not Receiving Chemotherapy or Radiation

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Investigate the Neuroprotective Effect of PROCRIT (Epoetin Alfa) Versus Placebo in Cancer Patients Who Develop Chemotherapy-induced Peripheral Neuropathy	NCT00267007	Peripheral Neur...	PROCRIT 40,000 ... Placebo	18 Years -	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
The Duration Study	NCT00210730	Anemia	epoetin alfa	18 Years -	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Hematologic Response of Epoetin Alfa (PROCRIT) Versus Darbepoetin Alfa (ARANESP) in Chemotherapy Induced Anemia	NCT00315484	Anemia Chemotherapy	Epoetin alfa an...	18 Years -	Ortho Biotech Products, L.P.
Early and Standard Intervention With 120,000 Units of PROCRIT (Epoetin Alfa) Every Three Weeks in Patients Receiving Chemotherapy	NCT00210600	Anemia	PROCRIT (Epoeti...	18 Years -	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
An Efficacy and Safety Study for Epoetin Alfa (PROCRIT) in Cancer Patients Not Receiving Chemotherapy or Radiation	NCT00210587	Anemia Neoplasms	epoetin alfa	18 Years -	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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