A Groupwide Phase II Study of Trastuzumab (Herceptin) in Metastatic Osteosarcoma Patients With Tumors That Overexpress HER2
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Feasibility and safety of treatment assessed using CTC version 2.0
研究概览
简要总结
Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and kill them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. Phase II trial to study the effectiveness of chemotherapy with or without trastuzumab in treating patients who have metastatic osteosarcoma
详细描述
PRIMARY OBJECTIVES:
I. Determine the feasibility and safety of trastuzumab (Herceptin) and chemotherapy in patients with HER2-overexpressing (2+ level of expression) metastatic osteosarcoma.
II. Determine the response rate and 3-year event-free survival of patients treated with this regimen.
III. Determine the cardiac toxicity and late effects of this regimen in these patients.
IV. Determine the response rate and 3-year event-free survival of poor-risk patients with HER2-negative tumors treated with chemotherapy without the addition of trastuzumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed high-grade osteosarcoma
- •Metastatic
- •Newly diagnosed
- •No osteosarcoma arising in areas of Paget's disease or radiotherapy-induced sarcoma
- •Presenting with at least 1 of the following:
- •Bone metastases with or without lung metastases
- •Bilateral lung metastases (any number of nodules)
- •Unilateral lung metastases with at least 4 nodules
- •Planned resection of either the primary site or a metastatic site of disease after completion of induction therapy
- •Must be currently enrolled on the tumor biology study COG-P9851
- •Performance status - ECOG 0-2
- •Performance status - Karnofsky 50-100% (over age 10)
- •Performance status - Lansky 50-100% (age 10 and under)
- •Absolute neutrophil count > 1,000/mm^3
- •Platelet count > 100,000/mm^3
- •Bilirubin ≤ 1.5 times normal
- •SGPT ≤ 3 times normal
- •Creatinine ≤ 1.5 times normal
- •Creatinine clearance or glomerular filtration rate ≥ 70 mL/min
- •Shortening fraction ≥ 28% by echocardiogram
- •Ejection fraction ≥ 50% by echocardiogram or MUGA
- •No history of pericarditis, myocarditis, symptomatic arrhythmia, or conduction disturbances
- •Normal organ function
- •HIV negative
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No prior chemotherapy
- •No prior radiotherapy
- •See Disease Characteristics
排除标准
- 未提供
研究组 & 干预措施
Treatment (combination chemotherapy)
See detailed description.
干预措施: doxorubicin hydrochloride (Drug)
Treatment (combination chemotherapy)
See detailed description.
干预措施: cisplatin (Drug)
Treatment (combination chemotherapy)
See detailed description.
干预措施: methotrexate (Drug)
Treatment (combination chemotherapy)
See detailed description.
干预措施: leucovorin calcium (Drug)
Treatment (combination chemotherapy)
See detailed description.
干预措施: filgrastim (Biological)
Treatment (combination chemotherapy)
See detailed description.
干预措施: therapeutic conventional surgery (Procedure)
Treatment (combination chemotherapy)
See detailed description.
干预措施: radiation therapy (Radiation)
Treatment (combination chemotherapy)
See detailed description.
干预措施: etoposide (Drug)
Treatment (combination chemotherapy)
See detailed description.
干预措施: ifosfamide (Drug)
Treatment (combination chemotherapy)
See detailed description.
干预措施: trastuzumab (Biological)
Treatment (combination chemotherapy)
See detailed description.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Feasibility and safety of treatment assessed using CTC version 2.0
时间窗: Up to 6 years
Descriptive statistics will be utilized to assess feasibility and safety. All toxicities will be carefully monitored. A detailed tabulation of observed toxicities will be made and a qualitative decision on the feasibility will be made.
Response rate
时间窗: Up to 6 years
Will be estimated with a maximum standard error of no more than 8%.
Event free survival (EFS)
时间窗: 3 years
Will be estimated by the Kaplan-Meier method with a maximum standard error of 8%.
次要结局
未报告次要终点