Phase II Study of Dacarbazine With the Anti-Vascular Endothelial Growth Factor Antibody (Bevacizumab) in Patients With Unresectable/Metastatic Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST)
研究概览
简要总结
This study will assess the preliminary anti-tumor activity and safety profile of a combination of bevacizumab and dacarbazine in participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed cutaneous malignant melanoma
- •Clinical evidence of metastatic disease and/or unresectable regional lymphatic disease and/or extensive in transit recurrent disease
- •Measurable and/or evaluable lesions according to RECIST
排除标准
- •Prior interferon alfa and/or cytokine therapy for metastatic disease
- •Prior chemotherapy for metastatic disease
- •Brain metastases
- •Chronic daily treatment with high-dose aspirin (more than 325 milligrams per day)
- •Other co-existing malignancies or malignancies diagnosed within the past 5 years with the exception of basal cell cancer or cervical cancer in situ
研究组 & 干预措施
Dacarbazine + Bevacizumab
Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease will receive dacarbazine and bevacizumab until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
干预措施: Bevacizumab (Drug)
Dacarbazine + Bevacizumab
Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease will receive dacarbazine and bevacizumab until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
干预措施: Dacarbazine (Drug)
结局指标
主要结局
Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
Tumor assessments were performed using RECIST. CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to sum of LD at Baseline. Both were to be confirmed at a follow-up visit at least 4 weeks from the initial assessment of CR or PR. The percentage of participants with a best overall response of CR or PR during the study was reported.
次要结局
- Percentage of Participants With Death or Disease Progression Following a Previous Assessment of CR or PR According to RECIST(Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months))
- Time to Treatment Failure (TTF)(Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months))
- Duration of Response (DOR) With CR or PR According to RECIST(Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months))
- Percentage of Participants With Death or Disease Progression Following a Previous Assessment of CR, PR, or Stable Disease (SD) According to RECIST(Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months))
- Time to Progression (TTP) According to RECIST(Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months))
- Percentage of Participants Who Discontinued Treatment(Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months))
- DOR With CR, PR, or SD According to RECIST(Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months))
- Percentage of Participants With Death or Disease Progression According to RECIST(Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months))
- Percentage of Participants Who Died(Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months))
- Overall Survival (OS)(Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months))