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Combination of Doxorubicin and Carnitine
for the Treatment of Stage III-IV Epithelial Ovarian Cancer

Objective: To evaluate the effect of doxorubicin combined with carnitine on tumor size reduction in patients with Stages III-IV epithelial ovarian cancer. Other factors such as cardiac function and general well being will be factored in the overall evaluation.

Patient Selection: Patients with histologically demonstrated epithelial ovarian carcinoma that progress while on therapy or recur within 6 months after completion of platinum-taxane therapy. Patients must have measurable disease and a predicted survival time of over 3 months. They have must have adequate renal and bone marrow function.

Primary Clinical Endpoint: Tumor size reduction.

Number of Patients: Approximately 20.

Methods: Carnitor (Sigma tau, Inc.) will be both the oral and intravenous formulations administered to the patients.

Days 1 – 7:
Patients will receive daily oral carnitine 500 mg oral solution to be administered twice a day.

Days 8 – 9:
On Day 8, patients will receive a one-hour infusion of carnitine 4 gm via an IV infusion, followed by carnitine 300 mg/hr for 23 hours via a portable infusion pump.

On Day 9, patients will receive a one-hour infusion of carnitine 4 gm via an IV infusion, followed by chemotherapy with the doxorubicin intravenous injection. Note: The dose of doxorubicin will be 60 to 75 mg/m2. The lower dosage should be given to patients with inadequate marrow reserves due to old age, or prior therapy, or neoplastic marrow infiltration.

This will be followed by carnitine 300 mg/hr for 23 hours via a portable infusion pump.

Days 10 – 20
Patients will receive the oral supplement daily to be taken twice a day.

This cycle will be repeated every 21 days. The doxorubicin dose will be increased by increments of 5 mg/m2 with each cycle, as tolerated, based on results of MUGA scans and general well being of the patient. The maximum doxorubicin dose will be 75 mg/m2.

Monitoring Tumor Size Response:
Imaging studies (CT Scans) will be performed at baseline, at 5th visit and at the final visit (9th).

Tumor size will be determined by the RECIST criteria as follows:

CR (complete response) = disappearance of all target lesions
PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions
PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions
SD (stable disease) = small changes that do not meet above criteria

Monitoring for Cardiotoxicity:

To assess for cardiotoxicity, patients will undergo MUGA scan evaluations at baseline and then every three months during the chemotherapy treatment period. Patients must have a left ejection fraction of at least 50% to enter the study. If this declines to less than 45% or decreases by 20% from the baseline, therapy will cease. If however, there is also tumor size reduction, a judgment will be made whether to and how to proceed on a case by case basis.

Duration:

The treatment will be continued until disease progression based on tumor size response. Any adverse effects/toxicity, apart from cardiotoxicity, will also be taken into account in determining continuation of treatment.

Patient Visits:

Patients will be seen in oncology clinic every 3 weeks to monitor blood counts, serum chemistries and CA-125 as well as their overall clinical condition.

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