A Phase II clinical study of response to zoledronic acid therapy for bone metastases in patients with non-small cell lung carcinoma as assessed by positron emission tomography (PET)

Peter MacCallum Cancer Centre0 个研究点目标入组 14 人开始时间: 2006年2月23日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. Signed informed consent 2.Histologically confirmed diagnosis of non-small cell lung carcinoma (NSCLC) – cytology alone is acceptable 3. Asymptomatic metastatic, previously unirradiated disease to the bone, detected by PET or PET/CT scan 4. Asymptomatic, assessable metastatic disease to previously unirradiated, non-osseous lesions detected by PET or PET/CT scan 5. ECOG performance status of 0-2. NB. Patients who are ECOG 2 must have a reduced PS due to comorbidities rather than their cancer 6. Estimated survival of at least 6 months 7. All potential patients, prior to registration must be reviewed at a multidisciplinary lung oncology meeting attended by medical oncologists, radiation oncologists and radiologists. 8. Women of child bearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 3 months after the study drug is ceased.

•1. Surgery or chemotherapy within 4 weeks prior to registration onto the study2. Patient planned to start immediate treatment with systemic chemotherapy3. Patient planned to start immediate treatment with palliative radiotherapy to an index lesion, osseous or non-osseous.4. Patient previously received systemic treatment for metastatic non-small cell lung cancer. Prior adjuvant chemotherapy is allowed.5. Treatment with bisphosphonates within the last year6. Initial serum creatinine > 1.5 times the ULN and/or calculated creatinine clearance (by Cockroft-Gault Formula) <60 ml/min and/or known progressive renal disease.7. Corrected serum calcium concentration < 2.00 mmol/L8. Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures. 9. Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants) 10. Another disease which could confound evaluation in this study11. Known hypersensitivity to zoledronic acid or other bisphosphonates12. Pregnancy or lactation13. Unlikely to cooperate fully during the study.

发起方

Peter MacCallum Cancer Centre