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 advanced ovarian cancer who develop chemotherapy-induced peripheral neuropathy due to paclitaxel and carboplatin treatment.

Condition	Intervention	Phase
Peripheral Neuropathy, Chemotherapy-Induced Ovarian Cancer	Drug: epoetin alfa	Phase II

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcomes: The change at Week 12 in the National Cancer Institute Common Toxicity Criteria (NCI CTC) neuropathy score as measured by an Oncologist.
Secondary Outcomes: The difference in the neuroprotective effect of epoetin alfa between subcutaneous (SC) injections and intravenous (IV) injections.
Expected Total Enrollment:  120

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, double-blind, placebo-controlled study is to evaluate the neuroprotective effect of PROCRIT® (epoetin alfa) administered once every week in patients with advanced epithelial ovarian cancer who develop chemotherapy-induced peripheral neuropathy due to treatment with paclitaxel and carboplatin. Patients will receive injections subcutaneously or intravenously of either epoetin alfa (40,000 Units) 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. 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 (40,000 Units) 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria: - Patients with histologically confirmed diagnosis of epithelial ovarian cancer, (FIGO stages II - IV), and no history of peripheral neuropathy - have had the appropriate surgery for ovarian or carcinoma and are no more than 12 weeks post-operatively at study entry - have not received chemotherapy (chemotherapy naïve patients) and are scheduled to receive at least 4 cycles of chemotherapy with the combination regimen of paclitaxel and carboplatin - have a hemoglobin value of >= 11 and < 13 g/dL - have a life expectancy of at least 6 months

Exclusion Criteria: - Patients who have had prior treatment with PROCRIT® or similar drugs (erythropoietic agents) within the last 2 months - have used experimental treatments within the last year that are reported or hypothesized to have neuroprotective potential, including amifostine, cyanocobalamin (vitamin B12), alpha-tocopherol (Vitamin E), glutamine, and gabapentin - have anemia due to factors other than cancer/chemotherapy, or have ongoing neuropathy due to any cause - received a transfusion of platelets or packed red blood cells within 28 days prior to the first dose of study medication - have a history of pulmonary emboli, deep vein thrombosis, ischemic stroke or any other history of arterial or venous thrombotic events

Please refer to this study by ClinicalTrials.gov identifier  NCT00267007

For more information please email       info@veritasmedicine.com

Study chairs or principal investigators

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial,  Study Director,  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.   

Study ID Numbers:  CR003247
Last Updated:  December 19, 2005
Record first received:  December 16, 2005
ClinicalTrials.gov Identifier:  NCT00267007
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10