NCT00043823已完成1 期
Safety and Efficacy of Recombinant Humanized Monoclonal Anti-VEGF Antibody rhuMAb VEGF and EGFR Tyrosine Kinase Inhibitor OSI-774 for Locally Advanced or Metastatic Non-Squamous Cell NSCLC in Patients Who Have Been Previously Treated
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose (MTD) of Tarceva in combination with Avastin
研究概览
简要总结
Primary Objectives:
- (Phase I) To establish the maximum tolerated dose and dose-limiting toxicities of the combination of OSI-774 (Tarceva™) and rhuMAb VEGF (Avastin™) in patients with advanced Non-small-cell lung carcinoma (NSCLC).
- (Phase II) To assess response rate and tolerability of the regimen at the dose level established in the phase I portion of this study.
Secondary Objectives:
- (Phase I and II) To evaluate the pharmacokinetic interaction between the combination.
- (Phase I) To establish a phase II regimen of the OSI-774/ rhuMAb VEGF combination, for further study alone or in combination with cytotoxic chemotherapy.
详细描述
Patients will be treated with oral Tarceva daily for 21 days each cycle. Patients will receive Avastin by IV on day 1 of each 21-day cycle. If a patient has no grade 3 or 4 toxicities after the 1st cycle, then the patient may continue the same doses of Tarceva and Avastin for another cycle. If the patient has response or stable disease after 6 weeks (2 cycles), the patient may continue on the same doses of Tarceva and Avastin. A patient may receive treatment on this study for up to one year, unless his or her disease progresses or side effects become too severe.
The starting dose is 100 mg daily of Tarceva and 7.5 mg/kg every 21 days of Avastin.
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
- •Patient has histologically proven stage IIIB with pleural effusion, stage IV or recurrent non-squamous NSCLC.
- •Patient has a Karnofsky performance status >=70%.
- •Patient has adequate bone marrow function: WBC >= 3,000 cells/mm3, ANC >= 1,500 cells/mm3, platelet count >= 100,000 cells/mm3, Hgb >= 9.0 g/dL.
- •Patient has adequate liver function: total bilirubin level <= 2.0 mg/dL, albumin >= 2.5 g/dL.
- •Transaminases (aspartate aminotransferase (AST or SGOT) and/or alanine aminotransferase (ALT or SGPT)) and alkaline phosphatase may be up to 2.5 x ULN.
- •Patient has adequate renal function: a serum creatinine < 2 mg/dl
- •Patient has signed a written informed consent.
- •Patient has received at least one prior chemotherapeutic regimen for recurrent or metastatic disease.
排除标准
- •Patient has not received prior chemotherapeutic regimens for advanced disease.
- •Patient has received prior biologic therapy targeting epidermal growth factor receptor (EGFR) and/or Vascular endothelial growth factor (VEGF).
- •Patient has received radiation therapy within the past 3 weeks.
- •Patient has signs or symptoms of acute infection requiring systemic therapy.
- •Patient exhibits confusion, disorientation, or has a history of major psychiatric illness that may impair patient's understanding of the informed consent.
- •Patient requires total parenteral nutrition with lipids.
- •Patient has a history of uncontrolled heart disease and/or uncontrolled hypertension (> 150/100 mmHg).
- •Because of the possible teratogenic effect, pregnant women and women who are currently breast-feeding may not participate in this study. - All women of childbearing potential must have a negative pregnancy test within 24 hours prior to enrolling in the study.
- •Serious infection or other intercurrent illness requiring immediate therapy.
- •Clinical/imaging evidence of Central Nervous System (CNS) malignancy or with recently treated CNS malignancy, as well as those experiencing recent cerebrovascular accident (CVA), or other CNS bleeding.
- •Pediatric patients in whom open growth plates would be expected.
- •Urine protein qualitative value of > 30 in urinalysis or > +1 in proteinuria testing by dipstick.
- •Patient has a clinical history of coagulopathy or thrombosis.
- •Patient is currently receiving or intending to receive anti-coagulants.
- •Patient has had a recent myocardial infarction (still inside the healing period). Note: a six-month window is optimal.
- •Patient is recovering from recent major surgery (e.g., less than 2 weeks since surgery) or is anticipating major surgery.
- •Patient has a clinical history of hemoptysis or hematemesis.
- •Patient may not have percutaneous endoscopic gastrostomy (PEG) or gastrostomy (G) tube.
研究组 & 干预措施
Avastin + Tarceva
Experimental
Combination Therapy (Avastin + Tarceva) = Avastin IV Day 1 of each 21-day cycle + oral Tarceva daily.
干预措施: Avastin (Drug)
Avastin + Tarceva
Experimental
Combination Therapy (Avastin + Tarceva) = Avastin IV Day 1 of each 21-day cycle + oral Tarceva daily.
干预措施: Tarceva (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of Tarceva in combination with Avastin
时间窗: After each 21 day cycle
次要结局
- Response in Patients With NSCLC Receiving Combination Avastin and Tarceva(6 weeks (2 cycles))
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Safety Study of IPI-504 in Patients With Gastrointestinal Stromal Tumors (GIST) or Soft Tissue Sarcomas (STS)Gastrointestinal Stromal TumorsSoft Tissue SarcomasNCT00276302Infinity Pharmaceuticals, Inc.63
已完成
1 期
First-in-Human Study of JNJ-74699157 in Participants With Tumors Harboring the KRAS G12C MutationNeoplasmsAdvanced Solid TumorsColorectal CancerNon-small Cell Lung CancerNCT04006301Janssen Research & Development, LLC10
进行中（未招募）
1 期
Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular DegenerationAge-Related Macular DegenerationNCT06674993Genentech, Inc.24
进行中（未招募）
1 期
Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular DegenerationAge-Related Macular DegenerationNCT02286089Hoffmann-La Roche24
已完成
1 期
Anti-Tac for Treatment of LeukemiaT Cell LeukemiaHTLV-I InfectionNCT00001941National Cancer Institute (NCI)34