A Randomized, Double-Blinded, Placebo-Controlled, Multi-Institutional, Cross-Over, Phase II.5 Study of AZD0530, a Selective Src Kinase Inhibitor, In Patients with Recurrent Osteosarcoma Localized to the Lung
To determine if the addition of AZD0530 to pulmonary metastasectomy versus placebo and pulmonary metastasectomy in patients with relapsed osteosarcoma, localized to the lung results in an increase in progression free survival and in overall survival.
Patients must be between the ages of 15 and 75 years of age with recurrent osteosarcoma, localized to the lung, who have had complete surgical removal of all lung nodules, or who are deemed fully resectable, will be enrolled. Patient must have histological diagnosis of osteosarcoma (osteoblastic, chondroblastic, fibroblastic or telangiectatic). Patient must relapsed after standard chemotherapy including: adriamycin, cisplatin, ifosphamide and methotrexate (or provide justification why any of these agents were not received). Patient may not be pregnant/breastfeeding Patient may not have any evidence of interstitial lung disease Patient may not have had a heart attack within 1 year prior to study entry Patient may not have had any prior chemotherapy within 28 days of study entry. Patients may not have any metastatic disease outside of the lungs. Good organ function and up and out of bed more then 50% of the day.
Treatment will be administered in the outpatient clinic. After screening procedures (bloodwork, history/physical exam, EKG, CT Scan/Bone Scan. Echocardiogram or MUGA) and patient is deemed eligible by the study doctor, patient will be enrolled into the study. Patient will be randomized (flip of a coin) to determine if patient is going to receive AZD0530 or placebo. This is a double blind study, so neither the patient, nor the study doctor will know if placebo is being given. Patient will take AZD0530/Placebo, orally (two tablets), once daily for 28 day cycle with no breaks between cycles. The total duration of treatment with AZD0530 will be 13 cycles (364 days total). The dose of AZD0530/Placebo is 175mg. Again, neither the study team, nor the participant will know if they are taking AZD0530 or the Placebo and to maintain the blind, the tablets will all look the same. Patient will be required to keep a daily diary of the time and dose of the drug ingested. Patients will be required to return to clinic for doctor visits/nurse visits/bloodwork/CT scans to follow progress on study and evaluate for any potential side effects and/or toxicities from the treatment. Signing consent means that the participant agrees to adhere to all study procedures outlines in the consent form.
12/13/2013 04:02 AM