PHASE I/II TRIAL OF TAXOL, IFOSFAMIDE, AND CISPLATIN FOR CISPLATIN-RESISTANT GERM CELL TUMOR PATIENTS WITH FAVORABLE PROGNOSTIC FEATURES
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting of paclitaxel, cisplatin, and ifosfamide in treating patients who have ovarian or testicular germ cell tumors that are refractory to platinum-containing chemotherapy.
详细描述
OBJECTIVES:
- Determine the toxicity and optimal dose of paclitaxel when combined with cisplatin and ifosfamide in patients with germ cell tumors with favorable prognostic features and resistance to cisplatin.
- Determine the efficacy of this regimen as salvage therapy in these patients.
OUTLINE: This is a dose escalation study of paclitaxel.
Patients receive paclitaxel IV continuously on day 1 and cisplatin IV over 20 minutes and ifosfamide IV over 30 minutes on days 2-6. Filgrastim (G-CSF) is administered subcutaneously (SC) on days 7-18 or until blood counts recover. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity. Additional patients receive paclitaxel at the MTD.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven germ cell tumor that is resistant to a platinum-based chemotherapy regimen
- •Active disease meeting 1 of the following conditions:
- •Measurable or evaluable disease
- •Elevated serum tumor markers (alpha-fetoprotein or human chorionic gonadotropin)
- •Unresectable residual disease after postchemotherapy surgery
- •Favorable prognostic factors for achieving a complete response (CR) to cisplatin-based salvage therapy required, including all of the following:
- •No more than 1 prior regimen or 6 prior courses of cisplatin
- •Testis or ovarian germ cell primary site
- •Prior CR to cisplatin therapy
- •Incomplete response to first-line therapy that was based on either carboplatin or a suboptimal regimen of cisplatin
- •PATIENT CHARACTERISTICS:
- •15 and over
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 8.0 g/dL
- •Not specified
- •Creatinine clearance greater than 50 mL/min
- •Renal dysfunction due to ureteral obstruction by tumor allowed at the discretion of the principal investigator
- •Cardiovascular:
- •If history of significant cardiac disease, evaluation and clearance by a cardiologist required prior to entry
- •No active infection not well controlled on antibiotics
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •No prior paclitaxel or ifosfamide
- •At least 3 weeks since prior chemotherapy
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •See Disease Characteristics
- •Recovered from recent surgery
排除标准
- 未提供