NCT00077688已完成2 期
A Phase 2 Multicenter Evaluation of the Safety and Efficacy of TOCOSOL(TM) Paclitaxel (S-8184 Paclitaxel Injectable Emulsion) in Patients With Metastatic or Locally Advanced, Unresectable Transitional Cell Carcinoma of the Urothelium
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 6
- 主要终点
- Objective response rate
研究概览
简要总结
Phase 2B, multicenter study evaluating the safety and efficacy of weekly TOCOSOL Paclitaxel in taxane-naive patients receiving second line chemotherapy for metastatic or locally advanced, unresectable transitional cell carcinoma of the urothelium
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic diagnosis of transitional cell carcinoma (TCC) of the urothelium including bladder, renal pelvis, ureter, or urethra
- •Stage IV disease
- •One and only one prior systemic cytotoxic chemotherapy regimen administered as adjuvant or neoadjuvant chemotherapy or to treat locally advanced or metastatic disease
- •Adequate hematologic function (ANC >/= 1500 cells/mm3 & platelet count >/= 100,000/mm3)
- •Serum creatinine </= 2.0 mg/dL
- •Total bilirubin </= 1.5 mg/dL
- •SGOT & SGPT </= 3 times upper limit of institutional normal values
- •PT (INR) & PTT within institutional lab normal range
- •Karnofsky performance status of 60-100%
- •At least one unidimensionally measurable lesion, suitable for radiographic evaluation of disease response, consistent with RECIST criteria
- •Signed IRB/EC approved Informed Consent
- •Life expectancy of at least 12 weeks
- •18 years of age or older
- •Fully recovered from any previous surgery
- •Not pregnant and willing to use a medically effective form of contraception during periods of chemotherapy treatment (both males and and females)
- •Agree not to take vitamin E supplementation while receiving study medication
- •Willing to participate in requested follow-up evaluations
- •Willing to permit treating physicians to provide information to Sonus regarding disease status and survival for 2 years after first dose of study drug
排除标准
- •Prior taxane-containing chemotherapy including Taxol(R) (paclitaxel) or generic equivalent, or Taxotere(R) (docetaxel)
- •Peripheral neuropathy NCI-CTC grade 2 or greater
- •Wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of first dose, or mitomycin or nitrosoureas within 6 weeks of first dose, of study drug
- •An investigational agent within 4 weeks of first dose of study drug
- •Concurrent anticonvulsants known to induce P450 isoenzymes
- •Patients who are pregnant or lactating
- •A history of carcinoma of another primary site (other than non-melanoma skin cancers or carcinoma-in-situ of the cervix) within the previous 5 years, unless metastatic disease has been biopsied and documented to be TCC
- •Bone metastasis, effusions, ascites or elevated tumor markers as the only evidence of metastatic TCC
- •Brain metastasis
- •Active bowel obstruction
- •Active, serious infection or other serious medical problems (other than TCC) likely to impair completion of the study protocol
结局指标
主要结局
Objective response rate
次要结局
- Time to treatment failure
- Time to progression
- Progression free survival
- Overall survival at 2 years
研究者
研究点 (6)
Loading locations...
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