Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma: Phase III Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 269
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This study evaluated two chemotherapy regimens with and without the addition of interferon in patients with advanced or recurrent melanoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of malignant melanoma in advanced stage or recurrent after surgery, and not amenable to further surgery or local therapy.
- •Presence of measurable disease
- •Age > or = 18 years and < or = 75 years
- •Performance status (ECOG) 0 - 2 (Appendix 2)
- •Life expectancy ³ 3 months
- •Adequate bone marrow function (ANC ³ 2,000/mmc; PTL ³ 100,000/mmc; Hb ³ 10 gr/dl), normal liver and renal function (bilirubin < 1.25 x N, creatinine < 1.25 x N, SGOT, SGPT < 3 times upper normal limit of testing laboratory.
- •Written, informed consent prior to study specific procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
- •Prior surgery > 3 weeks from initiating .
- •If palliative radiation is needed, in case of non target lesions, it must be given prior to initiating chemotherapy. If palliative radiation is required during the study the patient should be permanently discontinued from further treatment.
- •Adequate contraceptive measures during study participation for sexually active patients of child bearing potential must implement.
排除标准
- •Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin.
- •Prior chemo-immunotherapy ( previous adjuvant immunotherapy is allowed)
- •Known HIV disease.
- •Concurrent treatment with other experimental drugs.
- •Concurrent chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), radiation therapy
- •Pregnant or lactating females Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin.
- •Prior chemo-immunotherapy ( previous adjuvant immunotherapy is allowed) Known HIV disease. Concurrent treatment with other experimental drugs. Concurrent chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), radiation therapy
研究组 & 干预措施
A1
combination chemotherapy without interferon
干预措施: Dacarbazine (Drug)
A1
combination chemotherapy without interferon
干预措施: Fotemustine (Drug)
A2
combination chemotherapy with interferon
干预措施: Dacarbazine (Drug)
A2
combination chemotherapy with interferon
干预措施: Fotemustine (Drug)
A2
combination chemotherapy with interferon
干预措施: Interferon Alfa-2b (Drug)
B1
single agent dacarbazine without interferon
干预措施: Dacarbazine (Drug)
B2
single agent dacarbazine plus interferon
干预措施: Dacarbazine (Drug)
B2
single agent dacarbazine plus interferon
干预措施: Interferon Alfa-2b (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: 24 months
Overall Survival was defined as the time from the date of randomisation to the date of death from any cause or the date of last follow-up for living patients. OS curves were estimated with the Kaplan - Meier (K-M) method and treatments were compared with a two - sided log - rank test.
次要结局
- Progression Free Survival (PFS)(12 months)
- Treatment Related Toxicity(at end of each 3 week cycle of therapy up to the discontinuation)
- Overall Response Rate (ORR)(18 weeks from start of therapy)