A Phase II Study Of Intravenous DX-8951f (EXATECAN MESYLATE) Administered Daily For Five Days Every Three Weeks To Pediatric And Young Adult Patients With Ewing's Sarcoma (ES), Primitive Neuroectodermal Tumor (PNET), Or Desmoplastic Small Round Cell Tumor (DSRCT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 17
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients who have relapsed or refractory Ewing's sarcoma or peripheral primitive neuroectodermal tumor or desmoplastic small round cell tumor.
详细描述
OBJECTIVES:
- Determine the objective response rate in patients with Ewing's sarcoma, primitive neuroectodermal tumor, or desmoplastic small round cell tumor treated with exatecan mesylate.
- Determine the time to tumor progression in patients treated with this drug.
- Determine median survival and 6- and 12-month survival of patients treated with this drug.
- Determine the pain response in patients treated with this drug.
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is an open-label, non-randomized, multicenter study. Patients are stratified according to disease (relapsed or refractory localized or metastatic Ewing's sarcoma or primitive neuroectodermal tumor vs desmoplastic small round cell tumor).
Patients receive exatecan mesylate IV over 30 minutes on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity for a maximum of 12 courses, or 6 courses beyond maximal response (whichever is longer).
Patients are followed every 3 months for 1 year after withdrawal from study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •One of the following histologically confirmed diagnoses:
- •Relapsed or refractory Ewing's sarcoma or primitive neuroectodermal tumor
- •Desmoplastic small round cell tumor
- •Measurable disease
- •The following are not considered measurable disease:
- •Pleural effusion
- •Lytic bone lesions
- •No symptomatic brain metastases
- •PATIENT CHARACTERISTICS:
- •Performance status
- •ECOG 0-2 (over 10 years of age)
- •Lansky 60-100% (10 years of age and under)
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Absolute neutrophil count at least 750/mm^3
- •Platelet count at least 75,000/mm^3
- •Hemoglobin at least 8.5 g/dL
- •Bilirubin no greater than 2.0 mg/dL
- •AST or ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- •Albumin at least 2.8 g/dL
- •Creatinine less than 1.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active serious infection
- •No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No overt psychosis or mental disability that would preclude informed consent
- •No other life-threatening illness within the past 6 months
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 3 months since prior autologous bone marrow or stem cell transplantation
- •No concurrent biologic therapy
- •Chemotherapy
- •Recovered from prior systemic chemotherapy
- •Prior topoisomerase I inhibitor therapy allowed
- •No other concurrent chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •More than 4 weeks since prior cranial, spinal, or whole pelvis radiotherapy
- •More than 4 weeks since prior radiotherapy to 25% of bone marrow reserve
- •No concurrent radiotherapy
- •At least 4 weeks since prior major surgery and recovered
- •No concurrent surgery
- •More than 28 days since prior investigational drugs (including analgesics or antiemetics)
- •No more than 2 prior treatment regimens for this disease
- •No other investigational drugs during and for 28 days after study therapy
- •No other concurrent anticancer therapy
- 另有 1 项未显示
排除标准
- 未提供