INST 0601C: A Non-Randomized Phase II Protocol of Erlotinib for Patients With Newly Diagnosed, Advanced Non-Small Cell Carcinoma of the Lung
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 5
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
This study was conducted to compare the activities of erlotinib to that of intravenous, platinum-based therapy in the treatment of non-small cell lung cancer (NSCLC). The goal of this trial was to demonstrate clinical equivalence of erlotinib to platinum-based frontline therapy, compared to historical controls.
详细描述
To compare the activities (the progression-free survival, the incidence and severity of toxicities, and reversibility of toxicities) of erlotinib to that of platinum-based therapy in NSCLC. A sequential therapy design has been chosen such that all patients will receive any potential benefits of both platinum-based and erlotinib therapy, without compromising survival by denying anyone potential therapy. With this design, progression-free survival will be tracked by treatment received. However, data will be generated which will show the safety and efficacy of erlotinib in the frontline setting (alone and with historical comparison to platinum-based therapy), as well as the potential safety and activity of platinum-based therapy in the "second-line" (post-erlotinib) setting. This should allow for the demonstration of the relative median time to progression, objective response and clinical benefit rates, overall survival, and safety and tolerability of erlotinib and platinum-based therapy in both the frontline and second-line settings in NSCLC. Also, in this fashion, the treatments serve as controls for each other, as well as being compared to historical controls; in the first line treatment portion, the platinum-based regimens serve as the historical control, while in the second-line setting, erlotinib serves as the historical control arm.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior chemotherapy will be allowed for other invasive malignancies, provided at least five years has elapsed since the completion of therapy and enrollment on this protocol. No prior chemotherapy for metastatic non-small cell lung cancer (NSCLC) will be allowed. Prior adjuvant or neoadjuvant chemotherapy for NSCLC will be allowed, provided at least six months have elapsed from the last dose of chemotherapy to the documentation of relapsed disease.
- •Baseline laboratory values (bone marrow, renal, hepatic):
- •Adequate bone marrow function:
- •Absolute neutrophil count >1000/µL
- •Platelet count >100'000/µL
- •Renal function:
- •Serum creatinine < 2.0 mg %
- •Hepatic function:
- •Bilirubin <1.5x normal
- •Serum calcium < 12 mg/dl
- •Other Eligibility Criteria:
- •Signed Informed Consent
- •Eastern Cooperative Oncology Group (ECOG)/Zubrod/Southwest Oncology Group (SWOG) Performance Status <2 (Karnofsky Performance Status > 70%)
- •Life expectancy > 8 weeks
- •Male or female' age >18 years
- •Patients of childbearing potential must be using an effective means of contraception.
- •Histologic diagnosis of NSCLC that is advanced and cannot be treated adequately by radiotherapy or surgery; or metastatic disease
排除标准
- •Prior therapy with an epidermal growth factor receptor inhibitor, including erlotinib, gefitinib, and cetuximab, as well as any investigational HER-1 inhibiting agent
- •Pregnant or lactating females
- •Myocardial infarction or ischemia within the 6 months before Cycle 0' Day 0
- •Uncontrolled' clinically significant dysrhythmia
- •History of prior malignancy within the prior five years, with the exception of non-melanoma carcinomas of the skin, and carcinoma in situ of the cervix
- •Prior radiotherapy to an indicator lesion unless there is objective evidence of tumor growth in that lesion
- •Uncontrolled metastatic disease of the central nervous system (previously treated, stable disease is allowable on this protocol)
- •Radiotherapy within the 2 weeks before Cycle 1' Day 1
- •Surgery within the 2 weeks before Cycle 1' Day 1
- •Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications
研究组 & 干预措施
Erlotinib followed by chemotherapy
Erlotinib: 150 mg orally once daily,
Platinum-based chemotherapy regimen selections include:
Carboplatin (Carbo) area under the curve (AUC) 6, or cisplatin (Cis) 60-100 mg/m2, day (D)1, administered with one of the following:
- Docetaxel 75 mg/m2, D1
- Docetaxel 35 mg/m2, D1,8,15
- Paclitaxel 200-225 mg/m2, D1
- Paclitaxel 80-100 mg/m2, D1,8,15
Carbo AUC 5-6, or Cis 60-100 mg/m2, D1, administered with one of the following:
- Etoposide 100 mg/m2 D1-3
- Etoposide 200 mg/m2 orally D1-3
- Pemetrexed 500 mg/m2, D 1
- Irinotecan 50 mg/m2 D1,8,15
Other regimens:
- Gemcitabine 1000 mg/m2-1250 mg/m2, D1,8 + Carbo AUC 6, or Cis 60-100 mg/m2, D1 or 8
- Vinorelbine 25 mg/m2 D1,8 + Carbo AUC 5, or Cis 80 mg/m2 D1
干预措施: Erlotinib (Drug)
Erlotinib followed by chemotherapy
Erlotinib: 150 mg orally once daily,
Platinum-based chemotherapy regimen selections include:
Carboplatin (Carbo) area under the curve (AUC) 6, or cisplatin (Cis) 60-100 mg/m2, day (D)1, administered with one of the following:
- Docetaxel 75 mg/m2, D1
- Docetaxel 35 mg/m2, D1,8,15
- Paclitaxel 200-225 mg/m2, D1
- Paclitaxel 80-100 mg/m2, D1,8,15
Carbo AUC 5-6, or Cis 60-100 mg/m2, D1, administered with one of the following:
- Etoposide 100 mg/m2 D1-3
- Etoposide 200 mg/m2 orally D1-3
- Pemetrexed 500 mg/m2, D 1
- Irinotecan 50 mg/m2 D1,8,15
Other regimens:
- Gemcitabine 1000 mg/m2-1250 mg/m2, D1,8 + Carbo AUC 6, or Cis 60-100 mg/m2, D1 or 8
- Vinorelbine 25 mg/m2 D1,8 + Carbo AUC 5, or Cis 80 mg/m2 D1
干预措施: Platinum-based chemotherapy (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: 5 years
Toxicity Profile
时间窗: 28 days after last on-study treatment
Toxicities are assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3.0. Toxicities are reported as the number of patients who experienced grade 3 or grade 4 adverse events after receiving at least one dose of on-study treatment.
次要结局
未报告次要终点