A Placebo-Controlled Study of Saracatinib (AZD0530) in Patients With Recurrent Osteosarcoma Localized to the Lung

Status: Recruiting
Phase: Phase 2
Diagnosis: Pediatric Sarcoma, Sarcoma
NCT ID: NCT00752206 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 09-473

 

The purpose of this study is to determine how long patients who undergo complete surgical removal of recurrent osteosarcoma in the lung will remain free of cancer after taking Saracatinib compared to patients taking placebo (a sugar pill).

 

Conducting Institutions:
Dana-Farber Cancer Institute, Children's Hospital Boston, Massachusetts General Hospital, Brigham and Women's Hospital

Overall PI:
Katherine Janeway, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
David Harmon, MD, Massachusetts General Hospital

Contacts:
Dana-Farber Cancer Institute: Melissa Hohos, mhohos@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org
Dana-Farber Cancer Institute: Mark Morley, mmorley@partners.org

Eligibility Criteria

Inclusion Criteria: - Patient had recurrence of osteosarcoma, localized to the lungs, had complete surgical removal of all lung nodules are eligible for enrollment. - Patient with suspected recurrence of osteosarcoma but who has not had surgery is eligible for enrollment but will not be randomized to receive study medication until deemed fully eligible following surgical removal of all lung nodules. - Patient had histological confirmed diagnosis of osteosarcoma of the recurrent sample. - Patient had recurrence of osteosarcoma in the lung following standard therapy including: adriamycin, cisplatin, ifosfamide and methotrexate. - Patient is ≥ 15 and < 75 years of age. - Weight ≥ 34 kg. - ECOG performance score of 0-2. - Adequate bone marrow function. - Adequate renal function. - Adequate hepatic function. - Adequate cardiac function. - Women of childbearing potential must have had a negative pregnancy test (urine or serum) ≤ 7 days prior to enrollment, and willingness to use an acceptable method of contraception during participation in the study and for 3 months after the last dose. - Randomization must occur ≤ 6 weeks after complete surgical resection. - Patient or legal guardian has signed informed consent. Exclusion Criteria: - Presence of metastatic disease in other locations in addition to the lung. - Disruption of the lung pleura by tumor. - Paget's disease. - Patient currently using, or has previously used CYP3A4 inducers or inhibitors within 2 to 14 days prior to the initiation of oral therapy. - Known hypersensitivity to other Src/Abl non-receptor kinase inhibitors. - Evidence of interstitial lung disease. - Any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol. - Myocardial infarction within one year prior to study entry. - Bleeding diathesis, resulting in symptomatic bleeding. - Patient is pregnant or nursing/breast-feeding. - Patient received chemotherapy, biological or investigational agent ≤ 28 days prior to enrollment. - Patient experiencing unresolved toxicity ≥ CTCAE grade 2 (except alopecia) from previous agents.
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