NCT00055939已完成2 期
A Phase II Study Of Intravenous DX-8951f (EXATECAN MESYLATE) Administered Daily For Five Days Every Three Weeks To Pediatric Patients With Relapsed Or Refractory Rhabdomyosarcoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 18
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 children who have relapsed or refractory rhabdomyosarcoma.
详细描述
OBJECTIVES:
- Determine the objective response rate (complete and partial responses) in pediatric patients with relapsed or refractory rhabdomyosarcoma treated with exatecan mesylate.
- Determine the time to tumor progression in patients treated with this drug.
- Determine the median survival and survival at 6 and 12 months in patients treated with this drug.
- Assess pain in patients treated with this drug.
- Evaluate the quantitative and qualitative toxic effects of this drug in these patients.
- Evaluate the pharmacokinetics of this drug in these patients.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive exatecan mesylate IV over 30 minutes on days 1-5. Treatment repeats every 3 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 6 additional courses beyond CR.
PROJECTED ACCRUAL: A total of 13-27 patients will be accrued for this study within 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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:
- •Histologically confirmed recurrent or resistant rhabdomyosarcoma
- •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 old)
- •Lansky 60-100% (10 years old 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
- •Albumin at least 2.8 g/dL
- •AST or ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
- •Creatinine no greater than 1.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No life threatening illness (unrelated to tumor) within the past 6 months
- •No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No concurrent active serious infection
- •No concurrent uncontrolled infection
- •No overt psychosis or other incompetency that would preclude study compliance or giving informed consent
- •No other concurrent noncancer-related illness that would preclude study participation or follow-up
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 3 months since prior autologous bone marrow or stem cell transplantation
- •No concurrent anticancer biologic therapy
- •Chemotherapy
- •Recovered from prior adjuvant or systemic chemotherapy
- •Prior topoisomerase I inhibitor therapy allowed
- •No other concurrent anticancer chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •More than 4 weeks since prior extensive radiotherapy to the cranial-spinal axis, whole pelvis, or 25% of marrow reserve
- •No concurrent anticancer radiotherapy
- •At least 4 weeks since prior major surgery
- •Recovered from prior surgery
- •No concurrent anticancer surgery
- •At least 28 days since prior investigational drugs (including analgesics or antiemetics)
- •No more than 2 prior regimens for rhabdomyosarcoma
- •No concurrent grapefruit-containing beverages or foods
- •No other concurrent investigational drugs during and for 28 days after final dose of study drug
排除标准
- 未提供
研究者
研究点 (18)
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