Phase II Study Of Sequential Gemcitabine Followed By Docetaxel For Recurrent Ewing's Sarcoma, Osteosarcoma, Or Unresectable Or Locally Recurrent Chondrosarcoma [SARC Study]
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- Objective Response Rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining gemcitabine with docetaxel may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with docetaxel in treating patients who have recurrent osteosarcoma, recurrent Ewing's sarcoma, or unresectable or locally recurrent chondrosarcoma.
详细描述
OBJECTIVES:
Primary
- Determine the objective response rate in patients with recurrent osteosarcoma or Ewing's sarcoma or unresectable or locally recurrent chondrosarcoma treated with sequential gemcitabine and docetaxel.
Secondary
- Determine the time to progression in patients treated with this regimen.
- Assess the toxicity of this regimen in these patients.
- Compare the pharmacokinetics of this regimen vs gemcitabine alone in these patients.
- Obtain tumor samples for cDNA microarray analysis of gene expression and development of cell lines and xenotransplantation models.
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
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed* diagnosis of 1 of the following:
- •Recurrent high-grade osteosarcoma (closed to accrual as of 12/21/06) or Ewing's sarcoma
- •Progressive disease after standard therapy
- •Received no more than 2 additional salvage regimens
- •Chondrosarcoma
- •Unresectable OR locally recurrent and unable to be completely resected NOTE: *Biopsy required for isolated pulmonary recurrences
- •Measurable disease
- •At least 1 unidimensionally measurable lesion by medical imaging techniques
- •Ascites, pleural effusions, and bone marrow disease are not considered measurable disease
- •PATIENT CHARACTERISTICS:
- •4 and over
- •Performance status
- •ECOG (Eastern Cooperative Oncology Group) 0-2 (≥ 18 years of age)
- •Karnofsky 50-100% (11-17 years of age)
- •Lansky 50-100% (≤ 10 years of age)
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3 (transfusion independent)
- •Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
- •Bilirubin ≤ upper limit of normal (ULN) (except for patients with Gilbert's syndrome)
- •ALT ≤ 2.5 times ULN
- •Creatinine clearance or radioisotope glomerular filtration rate > 70 mL/min/1.73 m^2 OR
- •Serum creatinine ≤ ULN for age:
- •Ages 5 and under ≤ 0.8 mg/dL
- •Ages 6 to 10 ≤ 1.0 mg/dL
- •Ages 11 to 15 ≤ 1.2 mg/dL
- •Ages 16 to 18 ≤ 1.5 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study participation
- •Sensory or motor neuropathy due to prior chemotherapy ≤ grade 1
- •Sensory or motor neuropathy due to prior surgery or tumor involvement ≤ grade 2 AND stable or improving
- •No active or uncontrolled infection
- •No known hypersensitivity reaction to docetaxel or other polysorbate 80-formulated agents
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 72 hours since prior filgrastim (G-CSF)
- •No prior allogeneic transplantation
- •No concurrent immunotherapy
- •Chemotherapy
- •At least 2 weeks since prior myelosuppressive therapy
- •At least 6 months since prior myeloablative therapy
- •No prior gemcitabine
- •No prior taxanes
- •No other concurrent chemotherapy
- •Endocrine therapy
- •Concurrent hormonal therapy allowed
- 另有 9 项未显示
排除标准
- 未提供
结局指标
主要结局
Objective Response Rate
时间窗: After 2, 4, 8 and 12 cycles of therapy, each cycle is 21 days
Patients will be evaluated up to 4 time points(after 2,4,8 and 12 cycles of therapy), each cycle is 21 days. Per RECIST 1.0 and assessed by CT/MRI disease status will be categorized as R=CR/PR(response), F=progressive disease or death(failure), or S(stable disease=neither R nor F) based on the change from baseline. A patient with outcome R or F at any stage is scored as having that overall outcome, a patient with outcome S is re-evaluated after subsequent cycles of therapy. Patients who receive more than 14 cycles of therapy will be scored as the outcome at completion of cycle 14.
次要结局
- Time to Progression(post-cycle 2, 4, 8 and 12)
- Toxicity as Assessed by NCI CTCAE v3.0(Throughout the study)
- Pharmacokinetics of Gemcitabine Alone and Gemcitabine Followed by Docetaxel at Protocol Specified Timeframe in Participants Enrolled on Study(Gemcitibine: 0hr, 75, 85, 95, 105 and 120 min after the start of the 90 minute infusion; docetaxel: 0hr, 55 min, 30 min post infusion, 5hr and 24hr post infusion.)