Protocol Number: 09-C-0104 ![]()
- Standard therapy for osteosarcoma is a combination of chemotherapy and surgery to remove localized tumor nodules. However, osteosarcoma will recur in about 33 percent of patients who receive the standard treatment. - AZD0530 is an experimental drug treatment for cancer that works by inhibiting a protein known as Src, which is very common in patients with osteosarcoma. Some adult patients with cancer who received AZD0530 had a slowing of their tumor growth. Objectives: - To determine if the addition of AZD0530 decreases the chance of tumor recurrence and increases the rate of patient survival. - To see if AZD0530 reduces the amount of Src present in tumor samples. - To study tumor samples and genetic information to gain a better understanding of why osteosarcoma recurs in some patients. Eligibility: - Patients between 15 and 75 years of age with osteosarcoma in the lung, who have had successful surgery to remove osteosarcoma tumor nodules. Design: - Treatment with either AZD0530 or placebo, to begin 6 weeks after successful surgery. -Two tablets taken daily, by mouth, for a maximum of 1 year. -Study researchers may lower the dose if patients experience side effects from the drug. Patients will be removed from the study if side effects continue after two dose reductions. -Patients will be removed from the study if tumors recur during the treatment cycle. - Evaluations during the treatment period: -Physical examinations, including vital signs and body weight checks, and blood tests. -Analysis of tumor and blood samples to study genetic factors. -Disease evaluation with CT scans. -Other tests or examinations recommended by study doctors. - Post-treatment evaluations: -End-of-study visit for physical examination, disease assessment, and electrocardiogram. -Additional monitoring by researchers for up to 4 years.
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