Phase II Open-Label Study of Weekly Taxoprexin (DHA-paclitaxel) Injection as First Line Treatment of Patients With Metastatic Non-choroidal Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Percentage of Participants Who Achieved an Objective Complete Response (CR) or Partial Response (PR).
研究概览
简要总结
To evaluate objective response rate and duration of response to weekly Taxoprexin®.
To evaluate the safety profile of weekly Taxoprexin® in this patient population.
To evaluate overall survival in the same patient population. To evaluate time to disease progression, and the time to treatment failure in patients with metastatic malignant melanoma being treated with weekly Taxoprexin® Injection.
详细描述
This is a Phase II open-label study of weekly Taxoprexin® Injection in patients with metastatic malignant melanoma who have not received cytotoxic agents for advanced disease. Patients may have been previously treated with immunological agents including Interleukin-2 and vaccines. Patients will receive Taxoprexin® Injection at a dose of 500mg/m2 intravenously by 1-hour infusion weekly for the first five weeks of a six week cycle. Treatment will continue until progression of disease, intolerable toxicity, refusal of continued treatment by patient or Investigator decision.
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have malignant skin/mucosal (non-choroidal) melanoma, and documented metastatic disease.
- •Patients must have at least one measurable lesion.
- •Patients must not have received prior systemic chemotherapy for metastatic disease. Prior treatment with immunotherapy or vaccine therapy is allowed.
- •At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy.
- •At least 4 weeks (28 days) since prior radiotherapy to > 20% of the bone marrow and prior adjuvant chemotherapy.
- •Patients must have Eastern Cooperative Oncology Group performance status of 0-
- •Patients must be > 13 years of age. The safety of Taxoprexin has not been adequately studied in younger patients.
- •Patients must have adequate liver and renal function.
- •Patients must have adequate bone marrow function.
- •Life expectancy of at least 3 months
- •Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study and in keeping with the policies of the institution.
排除标准
- •Patients who have received prior therapy with any taxane.
- •Patients whose primary site was the choroid (eye).
- •Patients who have a past or current history of neoplasm other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or other cancers treated for cure and with a disease-free survival longer than 5 years.
- •Patients with symptomatic brain metastasis (es).
- •Patients who are pregnant or nursing and patients who are not practicing an acceptable method of birth control. Patients may not breastfeed while on this study.
- •Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
- •Patients with current peripheral neuropathy of any etiology that is greater than grade one (1).
- •Patients with unstable or serious concurrent medical conditions are excluded.
- •Patients with a known hypersensitivity to Cremophor.
研究组 & 干预措施
Taxoprexin
Taxoprexin 500 mg/m² intravenously every week for 5 weeks
干预措施: Taxoprexin (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved an Objective Complete Response (CR) or Partial Response (PR).
时间窗: Assessed every 6 weeks, up to 24 months
Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response \[CR\] or Partial Response \[PR\]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0. A complete response was defined as a disappearance of all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial response was defined as a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as reference the baseline sum of LD determined by 2 consecutive observations not less than 4 weeks apart.
次要结局
- Time to Progression(Assessed every 6 weeks until progression or death, up to 24 months)
- Time to Treatment Failure(Baseline to stopping treatment)
- Overall Participant Survival(Up to 24 months)