NCT00623402已完成2 期
Combined Treatment of Sorafenib and Pegylated Interferon α2b in Stage IV Metastatic Melanoma: a Prospective Non-randomized, Multicenter Phase II Study
University Hospital Schleswig-Holstein10 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 10
- 主要终点
- disease control rate (CR,PR,SD)
研究概览
简要总结
To evaluate the efficacy and safety of a combined treatment with Sorafenib (Nexavar®) and pegylated interferon-α-2b (PegIntron®) in patients with malignant melanoma in stage IV.
详细描述
This is a a prospective non-randomized, multicenter Phase II Study to evaluate the efficacy and safety of a combined treatment with Sorafenib (Nexavar®) and pegylated interferon-α-2b (PegIntron®) in patients with malignant melanoma in stage IV.
The investigators will determine disease control rate (CR,PR,SD) after 8 weeks of treatment with pegylated interferon- α-2b (3 µg/kg body weight s.c. once a week) combined with Sorafenib 2x 400 mg (2 tablets orally, twice daily)
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 documented metastatic melanoma classified as stage IV (AJCC 2002) of cutaneous origin.
- •≥ 18 years of age
- •ECOG performance status of 0 or 1
- •Patients should not have received any systemic treatment for stage IV disease (study = "first-line" treatment).
- •Patients with progressive disease (PD) to stage IV under prior treatment with interferons as well as all patients who have already been treated with Sorafenib should not be included.
- •The following are allowed:
- •adjuvant interferon treatment (without progressive disease during treatment!) or vaccine therapy for resected stage I-III disease
- •palliative surgery or radiotherapy for stage IV disease
- •prior cytokine or chemotherapy treatment for local-regional disease by isolated limb perfusion or intralesional therapy
- •Life expectancy >6 months.
- •Patients must have measurable disease defined as >= 1 not pretreated unidimensional measurable lesion >= 20 mm (conventional techniques) or >= 10 mm by spiral CT/MRI.
- •Patients must have adequate hematological, renal and liver functions as defined by laboratory values below performed within 14 days prior to study inclusion:
- •absolute neutrophil count (ANC) > 1.5 x 109/l
- •platelet count > 100 x 109/l
- •hemoglobin > 10 g/dl (> 6.2 mmol/l)
- •serum creatinine <= 1.5 x upper limit of institutional values
- •total serum bilirubin <= 1.5x upper limit of institutional values
- •ALAT and ASAT <= 2.5x upper limit of institutional values (exception: liver metastases)
- •In addition:
- •Patients should not suffer from frequent vomiting or medical conditions which could interfere with oral medication intake.
- •Negative pregnancy test of women of childbearing potential performed within 7 days prior to the start of treatment.
- •Women of childbearing potential must agree to use an effective method of contraception (Pearl-Index < 1, e.g. hormonal contraception including the combined oral contraceptive pill, the transdermal patch, and the contraceptive vaginal ring, intrauterine devices or sterilization) during treatment and for at least 6 months thereafter.
- •Men must agree to use an effective method of contraception during treatment and for at least 6 months thereafter.
- •Patients should understand the informed consent and will need to sign the consent
排除标准
- •Ocular or mucosal melanoma.
- •History or evidence of brain metastasis.
- •Patients with LDH values higher than 2x upper limit of institutional values.
- •Patients with thyroid dysfunctions not responsive to therapy.
- •Patients with uncontrolled diabetes mellitus.
- •Patients with prior or active autoimmune disease or autoimmune hepatitis.
- •Cardiac disease: congestive heart failure > class II NYHA, patients must not have unstable angina or new onset of angina or myocardial infarction within the past 6 months. Cardiac ventricular arrhythmias requiring antiarrhythmic therapy.
- •Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal management.
- •Active clinically serious infections > CTCAE Grade
- •Patients who are HIV positive or have AIDS.
- •Thrombotic or embolic events including transient ischemic attacks within the past 6 months.
- •Evidence or history of bleeding diathesis or coagulopathy.
- •Therapeutic anticoagulation with Vitamin K antagonists such as warfarin, or with heparins or heparinoids. Low dose warfarin is permitted if INR is < 1.
- •Low dose aspirin is permitted.
- •Known or suspected allergy to Sorafenib or any ingredient of Sorafenib or PEG-IFN-α -2b or any ingredient of PEG-IFN-α -2b or to any interferone.
- •Previous cancer that is distinct in primary site or histology from melanoma except cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors or any cancer curatively treated 3 years prior to study entry.
- •Substance abuse, medical or psychological condition that may interfere with the patient´s participation in the study.
- •Patients with medication requiring chronic systemic corticosteroids.
- •Patients with prior systemic anticancer treatment in the last 2 weeks.
- •Patients with severe liver disease or severe renal disease.
- •Patients with seizure disorders requiring anticonvulsant therapy.
- •Patients with any severe debilitating diseases.
研究组 & 干预措施
A
Experimental
干预措施: Sorafenib (Drug)
A
Experimental
干预措施: pegylated interferon α-2b (Drug)
结局指标
主要结局
disease control rate (CR,PR,SD)
时间窗: 8 week staging
次要结局
- Overall survival(48 week follow-up)
- Safety and tolerability of the combined treatment(During active treatment)
- Best response(12 months)
- Progression free survival (PFS)(During active treatment)
研究者
研究点 (10)
Loading locations...
相似试验
进行中（未招募）
不适用
Combined Treatment of Sorafenib and pegylated interferon a2b in stage IV metastatic melanoma: a prospective non-randomized, multicenter Phase II StudySoraPeg Trial - SoraPeg TrialDie Studie ist eine nicht-randomisierte, multizentrische und prospektive Phase II-Studie.Im Rahmen der Studie soll eine kombinierte Behandlung mit Sorafenib und pegyliertem Interferon a2b im Stadium IV des metastasierten malignen Melanoms durchgeführt werden. Das Ziel der Studie ist es, die Wirksamkeit und Sicherheit dieser Kombinationsbehandlung zu überprüfen.EUCTR2007-001918-16-DEniversitätsklinikum Schleswig-Holstein, Campus Kiel
终止
2 期
Sorafenib With Capecitabine for Patients With Measurable Hepatocellular CarcinomaHepatocellular CarcinomaNCT01032850New Mexico Cancer Care Alliance15
Unknown
不适用
PEG-IFN Plus Ribavirin Combination Therapy for Older PatientsHepatitis C VirusNCT00956982Kyushu University1,251
已完成
1 期
Sorafenib With Irinotecan in Metastatic Colorectal Cancer (mCRC) and K-RAS MutationMetastatic Colorectal CancerNCT00989469Institut du Cancer de Montpellier - Val d'Aurelle64
已完成
1 期
Phase I Trial of Sorafenib + FOLFIRI In Metastatic Colorectal CancerMetastatic Colorectal CancerNCT00780169Ottawa Hospital Research Institute16