A Pilot Study of Low Dose Suramin as Modulator of Docetaxel and Gemcitabine in Patients With Previously Treated Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Safety of suramin, graded according to the revised NCI CTC version 2.0
研究概览
简要总结
This randomized phase I trial is studying the side effects and best dose of suramin when given together with either docetaxel or gemcitabine in treating patients with stage IIIB or stage IV non-small cell lung cancer that is refractory to platinum chemotherapy (such as cisplatin, carboplatin, or oxaliplatin). Drugs used in chemotherapy such as docetaxel and gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Combining suramin with either docetaxel or gemcitabine may reduce resistance to the drugs and kill more tumor cells.
详细描述
OBJECTIVES:
I. Determine the safety of low-dose suramin administered with docetaxel or gemcitabine in patients with stage IIIB or IV platinum-refractory non-small cell lung cancer.
II. Determine, preliminarily, the antitumor activity of these regimens in these patients.
III. Determine whether suramin plasma concentrations in combination with docetaxel or gemcitabine can be predicted by pretreatment dose calculations based on clinical parameters.
OUTLINE: This is a randomized, pilot, dose-finding study. Patients are randomized to 1 of 2 treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 or cytologically confirmed non-small cell lung cancer
- •Stage IIIB* or IV
- •Progressive disease after prior platinum-containing regimen (e.g., cisplatin, carboplatin, or oxaliplatin)
- •No known brain or leptomeningeal disease, unless all of the following are true:
- •Lesions were previously irradiated
- •No concurrent corticosteroids
- •No clinical symptoms
- •Performance status - ECOG 0-2
- •At least 12 weeks
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 9.0 g/dL
- •Bilirubin no greater than 1.5 mg/dL
- •AST/ALT no greater than 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 2.5 times ULN
- •Creatinine no greater than 2.0 mg/dL
- •No myocardial infarction within the past 6 months
- •No congestive heart failure requiring therapy
- •No unstable angina
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active serious infectious process
- •No grade 2 or greater neuropathy
- •No uncontrolled diabetes mellitus
- •No psychiatric disorder that would preclude giving informed consent or interfere with study follow-up
- •See Disease Characteristics
- •At least 28 days since prior cytotoxic chemotherapy and recovered
- •No more than 2 prior chemotherapy regimens
- •No prior docetaxel
- •No prior gemcitabine
- •See Disease Characteristics
- •See Disease Characteristics
- •Prior radiotherapy allowed
- •At least 2 weeks since prior epidermal growth factor receptor therapy
- •Prior suramin allowed
- •No concurrent anti-HIV medications for HIV-positive patients
排除标准
- 未提供
研究组 & 干预措施
Arm II
Patients receive low-dose suramin IV over 30 minutes and gemcitabine IV over 30 minutes on days 1 and 8.
干预措施: suramin (Drug)
Arm I
Patients receive low-dose suramin IV over 30 minutes and docetaxel IV over 1 hour on day 1.
干预措施: suramin (Drug)
Arm I
Patients receive low-dose suramin IV over 30 minutes and docetaxel IV over 1 hour on day 1.
干预措施: docetaxel (Drug)
Arm I
Patients receive low-dose suramin IV over 30 minutes and docetaxel IV over 1 hour on day 1.
干预措施: laboratory biomarker analysis (Other)
Arm I
Patients receive low-dose suramin IV over 30 minutes and docetaxel IV over 1 hour on day 1.
干预措施: pharmacological study (Other)
Arm II
Patients receive low-dose suramin IV over 30 minutes and gemcitabine IV over 30 minutes on days 1 and 8.
干预措施: gemcitabine hydrochloride (Drug)
Arm II
Patients receive low-dose suramin IV over 30 minutes and gemcitabine IV over 30 minutes on days 1 and 8.
干预措施: laboratory biomarker analysis (Other)
Arm II
Patients receive low-dose suramin IV over 30 minutes and gemcitabine IV over 30 minutes on days 1 and 8.
干预措施: pharmacological study (Other)
结局指标
主要结局
Safety of suramin, graded according to the revised NCI CTC version 2.0
时间窗: Up to 30 days after completion of study treatment
Recommended dose of chemotherapy, defined as the dose at which no more than 1/6 patients develop DLT graded according to the revised NCI CTC version 2.0
时间窗: Up to 21 days
次要结局
未报告次要终点