Phase 2 Study Cabazitaxel as Salvage Treatment for Cisplatin-resistant Germ Cell
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 4
- 主要终点
- Objective response rate
研究概览
简要总结
Germ cell tumors belong to the most chemosensitive malignancies. Paclitaxel in combination with ifosfamide and cisplatin (TIP) has become a common regimen for salvage treatment of germ cell cancer.
Cabazitaxel may overcome resistance to docetaxel and paclitaxel and might have clinical activity in patients with metastatic and progressive germ cell tumors.
详细描述
Patients with metastatic germ cell cancer and relapse after two or more courses of cisplatin-based chemotherapy or after high-dose chemotherapy have a poor prognosis and no curative options. Taxanes in various combinations unfold cytotoxic effects on germ cell tumors resistant to conventional doses of cisplatin. Paclitaxel in combination with ifosfamide and cisplatin (TIP) has become a common regimen for salvage treatment of germ cell cancer. In most patients, however, resistance to paclitaxel, as evidenced by progression occurs.Cabazitaxel has been developed to overcome resistance to docetaxel and paclitaxel. It has shown efficacy in patients progressing during docetaxel therapy in a large phase III trial (TROPIC) in patients with castration-resistant prostate cancer. Furthermore, chemotherapy resistance might be less likely to develop in patients receiving cabazitaxel as compared to other taxanes.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients ≥ 18 years old
- •Histologically verified metastatic germ cell cancer (GCC) of the testicle or extragonadal GCC originating from retroperitoneum or mediastinum
- •Disease progression during cisplatin-based chemotherapy or Disease progression or relapse after high-dose chemotherapy or Disease progression or relapse after at least 2 different cisplatin-based regimens
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0-2
- •Life expectancy ≥ 3 months
- •At baseline adequate function of liver, kidneys and bone marrow:
- •·Neutrophils ≥ 1.5 x 109/L·
- •Hemoglobin ≥ 9.0 g/dL
- •Platelets ≥ 100 x 109/L
- •Creatinine ≤ 1.5 x upper limit of normal (ULN)
- •Total Bilirubin ≤ 1.0 x ULN
- •Serum glutamate oxaloacetate transaminase (SGOT/AST) ≤ 1.5 x ULN
- •Serum glutamate pyruvate transaminase (SGPT/ALT) < 1.5 x ULN
排除标准
- •Systemic antitumor treatment within 21 days before study entry
- •Simultaneous radiotherapy to the only target lesion
- •Patients unwilling or unable to comply with the protocol
- •Patients with unstable angina pectoris, myocardial infarction ≤ 6 months prior to first study treatment, congestive heart failure New York Heart Association (NYHA) III-IV or serious uncontrolled cardiac arrhythmias
- •Patients with an active or uncontrolled infection
- •Patients who have a history of another primary malignancy and are off treatment for ≤ 3 years, with the exception of non-melanoma skin cancer
- •Patients who have undergone major surgery within 4 weeks prior to starting study drug (e.g. intra-thoracic, intra-abdominal, or intra-pelvic) or significant traumatic injury, or who have not recovered from the side effects of any of the above within 6 weeks
- •Patients who have participated in another interventional clinical trial within 30 days before study entry
- •Other serious medical conditions that could impair the ability of the patient to participate in the study
- •Active infection requiring systemic antibiotic-, anti-viral-, or anti-fungal medication
- •Neuropathy ≥Grade 2 Common Terminology Criteria for Adverse Events (CTCAE)
- •Patient with reproductive potential not implementing accepted and effective method of contraception during the whole study period and up to 6 months after the last dose of cabazitaxel
- •One or more of the following cabazitaxel-specific requirements:
- •History of severe hypersensitivity reaction (≥ Grade 3) to docetaxel
- •History of severe hypersensitivity reaction (≥ Grade 3) to polysorbate 80 containing drugs
- •Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4 (CYP3A4) (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix A and B)
- •Concurrent or planned treatment with Organic anion transporting polypeptide1B1 (OATP1B1) substrates e.g. statins, valsartan, repaglinide which have to be taken within 12 hours before cabazitaxel application and 3 hours after the end of infusion, refer table 9
研究组 & 干预措施
Cabazitaxel (single arm study)
Cabazitaxel 25 mg/m2 each 3. week (no other drugs will be administered)
干预措施: cabazitaxel (Drug)
结局指标
主要结局
Objective response rate
时间窗: after 3 and 6 cycles of cabazitaxel (9 and 18 weeks, respectively) as change from baseline (radiologic evaluation before first cycle of cabazitaxel)
Recist 1.1
次要结局
未报告次要终点
研究者
Jan Oldenburg
MD, PhD, Coordinating Investigator
University Hospital, Akershus