NCT00473486终止1 期
A Randomized (PhaseII), Double-blind, Multicenter Phase I/II Trial of Pemetrexed, Carboplatin Plus or Minus Sorafenib in the First-line Treatment of Patients With Stage IIIb or IV Non-Small Cell Lung Cancer
University Hospital Muenster1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2007年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Ph.1: Identify the recommended phase II dose of sorafenib for combination therapy with carboplatin and pemetrexed
研究概览
简要总结
The majority of patients with advanced NSCLC treated with standard platinum based chemotherapy regimens ultimately develop disease progression. Active therapies with improved toxicity profiles are clearly needed in this setting. The primary objective of this trial is to assess the toxicity profile and to determine the effect on progression free survival and time to progression in patients with advanced NSCLC treated with sorafenib in addition to carboplatin and pemetrexed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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 NSCLC
- •Locally advanced (stage IIIB with malignant pleural or pericardial effusion) or metastatic (stage IV) NSCLC
- •No prior systemic chemotherapy
- •Prior local radiotherapy is allowed if it is completed at least 3 weeks prior to the first dose of study medication; also concomitant palliative radiotherapy to an existing bone lesion for pain control is allowed
- •Prior surgery is allowed if it is performed at least 4 weeks prior to the first dose of study medication and patient should be fully recovered.
- •Must have measurable disease with at least one lesion with a longest diameter measured as ≥ 2 cm with conventional techniques or as ≥ 1 cm with spiral CT
- •Age ≥18 years old
- •ECOG performance score (PS) 0-1
- •Life expectancy of at least 12 weeks
- •Adequate bone marrow, renal and hepatic function
- •hemoglobin ≥ 9.0 g/dl
- •absolute neutrophil count ≥1,500/mm3
- •platelet count ≥ 100,000/mm3
- •total bilirubin ≤ 1.5 times the upper limit of normal
- •ALT and AST ≤ 2.5 times the upper limit of normal (≤ 5 x upper limit of normal for patients with liver involvement)
- •INR ≤ 1.5 and aPTT within normal limits
- •serum creatinine ≤ 1.5 the upper limit of normal
- •Patients with creatinine clearance ≥ 45 mL/min
- •Not pregnant or nursing patients
- •Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
- •Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least six months after the last administration of sorafenib
- •Signed informed consent prior to any study specific procedures
- •Compliance and geographic proximity that allow adequate follow-up
排除标准
- •Any prior systemic anticancer therapy including cytotoxic therapy, targeted agents, experimental therapy (treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study enrollment), adjuvant, or neo-adjuvant therapy for NSCLC
- •Any participation in a clinical trial 30 days prior to study entry and concomitantly to the study
- •Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina (angina symptoms at rest) or new-onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
- •Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- •Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal medical management
- •Documented brain metastases (unless the patient is > 6 months from definitive therapy for brain metastases, has a negative imaging study within 4 weeks of study entry and has been off corticosteroids for at least 4 weeks before study enrolment). Brain imaging (CT scan/MRI) is required in symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients.
- •Patients with seizure disorder requiring medication (such as steroids or antiepileptics)
- •Known HIV infection or chronic hepatitis B or C
- •Active clinically serious infections > CTCAE Grade 2
- •Presence of clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study enrolment
- •Pulmonary hemorrhage/bleeding event >= CTCAE Grade 2 within 4 weeks of first dose of study drug
- •Any other hemorrhage/bleeding event > =Grade 3 within 4 weeks of first dose of study drug
- •Evidence or history of bleeding diathesis or coagulopathy
- •Therapeutic anticoagulation with vitamin K antagonists such as phenprocoumon, warfarin, or with heparins or heparinoids. Low dose anticoagulation is permitted
- •Serious, non-healing wound, ulcer, or bone fracture
- •Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug
- •Known or suspected allergy to sorafenib, carboplatin or pemetrexed
- •Previous or current cancer that is distinct in primary site or histology from NSCLC except cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors (Ta and Tis) or any cancer curatively treated > 3 years prior to study entry
- •Substance abuse, medical, psychological or social conditions that may interfere with the patients participation in the study
- •Significant weight loss (> or equal 10% body weight during preceeding 6 weeks)
- •Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose ≤ 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam)
- •Inability or unwillingness to take folic acid, vitamin B12 supplementation or corticosteroids
- •Recent (within 30 days of enrolment) or concurrent yellow fever vaccination
- •Serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol.
研究组 & 干预措施
1
Active Comparator
Pemetrexed, Carboplatin plus Sorafenib in the first-line treatment of patients with stage IIIb or IV NSCLC
干预措施: pemetrexed, carboplatin, sorafenib (Drug)
2
Placebo Comparator
Pemetrexed, Carboplatin plus placebo in the first-line treatment of patients with stage IIIb or IV NSCLC
干预措施: pemetrexed, carboplatin, placebo (Drug)
结局指标
主要结局
Ph.1: Identify the recommended phase II dose of sorafenib for combination therapy with carboplatin and pemetrexed
时间窗: July 2008
Ph.2: Compare the PFS of carboplatin/pemetrexed + sorafenib or carboplatin/pemetrexed + placebo in patients with stage IIIb or IV non-small cell lung cancer
时间窗: May 2009
次要结局
- Ph.1: Determine dose limiting toxicity(July 2008)
- Ph 1: Determine the safety profile of the combination treatment(July 2008)
- Ph 1: descriptive analysis of efficacy(July 2008)
- Ph.2: Compare PFS of carboplatin/pemetrexed + sorafenib or carboplatin/pemetrexed + placebo in patients with stage IIIb or IV NSCLC(May 2009)
- Ph 2: Assess time to progression in patients treated with either regimen(May 2009)
- Ph 2: Determine the overall survival in patients treated with either regimen(May 2009)
- Ph 2: Determine the objective response rate (CR, PR), disease control rate (CR,PR,SD), time to response and duration of response(May 2009)
- Ph 2: Identify surrogate markers from the tumor biopsy or resection specimen from the time of diagnosis that predict response(May 2009)
- Ph 2: Assess Quality of Life of patients treated with either regimen(May 2009)
- Ph 2: Assess feasibility and toxicity profile of this regimen(May 2009)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Trial to Evaluate Safety and Efficacy of Vinorelbine With Metronomic Administration in Combination With Atezolizumab as Second-line Treatment for Patients With Stage IV Non-small Cell Lung CancerNon-small Cell Lung CancerNCT03801304University Hospital, Brest80
已完成
2 期
Study for Therapy of Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) With Cisplatin / Docetaxel or Oxaliplatin / DocetaxelNon Small Cell Lung CancerNCT01222312Krankenhaus Nordwest88
Unknown
3 期
Effect of All-trans Retinoic Acid With Chemotherapy Based on Paclitaxel and Cisplatin As First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer and Expression of RAR-alfa and RAR-beta as Response BiomarkerNon Small Cell Lung CancerNCT01041833National Institute of Cancerología230
已完成
2 期
Tetracycline as a Prophylaxis for Rash in Patients With NSCLC Receiving Treatment With BIBW2992 (Afatinib)Skin RashLung CancerNCT01880515Instituto Nacional de Cancerologia de Mexico107
终止
2 期
Platinum-Based Chemotherapy Plus Ramucirumab in Patients With Advanced NSCLC Who Have Progressed on First Line Anti-PD-1 ImmunotherapyCarcinoma, Non-Small-Cell LungNCT03904108ROGER S KERESZTES MD3