A Phase I - II Open Label Study of the Maximum Tolerated Dose, Safety and Efficacy of Docetaxel and Cisplatin Plus STI571 in Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 43
- 主要终点
- Phase 1 - Maximum Tolerated Dose (MTD) of STI571
研究概览
简要总结
This is a Phase 1/Phase 2 study of STI571 combined with docetaxel and cisplatin for treatment of patients with recurrent and metastatic Non-Small Cell Lung Cancer (NSCLC).
This research study has 2 parts to it. The first part (Phase 1) is called a dose-escalation. Not all subjects enrolled into this phase of the study will receive the same dose. The purpose of the dose-escalation is to determine the highest safe dose of STI571 that can be used in combination with docetaxel and cisplatin. That dose will be used in Phase 2.
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
- •Patients must have histologically or cytologically recurrent, or advanced NSCLC: Stage IV disease; or Stage IIIB due to malignant pleural effusion is allowed- only if successfully pleurodesed.
- •Tumor tissue slides must express phosophorylated pdgf-rB by IHC.
- •At least one measurable target lesion as defined by RECIST criteria that has not been irradiated.
- •No prior chemotherapy treatment for this disease will be allowed. Patients with brain metastasis will have to be, after appropriate treatment, neurologically stable for at least 1-2 weeks (off steroids) prior to study enrollment.
- •ECOG performance status 0-
- •Meets initial laboratory parameters.
- •Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
- •Exclusion Criteria
- •Any prior treatment with a biologic response modifier or chemotherapeutic agent for this disease.
- •Any concomitant malignancy except non-melanoma skin cancer or in-situ carcinoma of the cervix.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to STI571 and/or docetaxel, or other drugs formulated with polysorbate 80 and/or cisplatin.
- •Patients with:
- •Contrast allergy.
- •GI bleed ≤ 1 month from study enrollment.
- •Intermittent or chronic oxygen requirements.
- •Pulse oximetry <90%.
- •Grade 3 dyspnea.
- •History of poorly regulated anticoagulation with warfarin.
- •Edema or fluid retention grade >
- •Neuropathy grade ≥
- •Uncontrolled inter-current medical illness including, but not limited to, ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure, unstable angina pectoris, ≤3 months myocardial infarction or cardiac arrhythmia.
- •Psychiatric illness/social situations that would limit compliance with study requirement or that would prevent informed consent or psychiatric illness/social situations requiring inpatient treatment within the past 3 months.
- •Any type of hearing impairment.
- •Known HIV infection.
- •Receiving other investigational agents.
排除标准
- 未提供
结局指标
主要结局
Phase 1 - Maximum Tolerated Dose (MTD) of STI571
时间窗: After cycle 1, day 22
To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin, when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.
Phase 1 - Maximum Tolerated Dose (MTD) of Docetaxel and Cisplatin
时间窗: After cycle 1, day 22
To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.
Phase II - Radiographic Response
时间窗: After Cycle 6, approximately 18 weeks.
The percentage of patients with a complete or partial response. Responses for the Phase II portion of the trial will be by Response Evaluation Criteria In Solid Tumors (RECIST) criteria as follows: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
次要结局
- Phase 2: 1 Year Survival(1 year)
- Change in Gd-MRI Measurement(Day 7)