A PHASE I STUDY OF THE COMBINATION OF CAI AND PACLITAXEL IN ADULT PATIENTS WITH REFRACTORY CANCERS OR LYMPHOMA
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 4
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of carboxyamidotriazole and paclitaxel in treating patients with advanced solid tumors or refractory lymphomas.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of paclitaxel when combined with carboxyamidotriazole in patients with advanced solid tumors or refractory lymphomas.
- Determine the pharmacokinetics and toxicities of this regimen in these patients.
- Identify diseases for which this combination appears active.
OUTLINE: This is a dose escalation study.
Patients receive oral carboxyamidotriazole (CAI) daily with paclitaxel IV over 3 hours on day 8 and every 3 weeks thereafter. Course 1 is 28 days and all other subsequent courses are 21 days. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response receive 2 additional courses of treatment.
Sequential dose escalation of CAI is followed by sequential dose escalation of paclitaxel. Dose escalation in cohorts of 3 to 6 patients each continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically diagnosed solid tumor (i.e., breast and ovarian epithelial carcinomas) or lymphoma
- •Slides reviewed at the NCI Laboratory of Pathology
- •Failure on therapy of proven efficacy for the disease
- •Prior therapy not required for the following metastatic diseases:
- •Non-small cell lung cancer
- •Renal cell carcinoma
- •No brain metastases
- •Primary brain tumors (such as glioblastoma multiforme) with stable neurologic deficits allowed
- •Measurable or evaluable disease required
- •Demonstrated by physical exam or on radiograph within 2 weeks prior to initiation of treatment OR
- •Elevated PSA associated with prostate cancer
- •Other marker-only disease ineligible
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Hematocrit at least 27%
- •Liver function tests no greater than 2 times upper limit of normal
- •Bilirubin normal
- •PT or PTT no greater than 1.25 times upper limit of normal
- •Clotting parameters normal
- •No concurrent anticoagulants other than 1 mg of warfarin per day for prophylaxis
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance at least 45 mL/min
- •No kidney obstruction
- •Cardiovascular:
- •No cardiac conduction defect requiring antiarrhythmics
- •No evidence of myocardial infarction or other myocardial damage within past 6 months
- •HIV negative
- •No concurrent infection
- •No guaiac-positive stool test
- •No neuropathy greater than grade I (unless associated with fixed-deficit primary brain tumors)
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for 2 months after study
- •PRIOR CONCURRENT THERAPY:
- •Recovery from prior therapy required
- •Biologic therapy:
- •At least 4 weeks since prior biologic therapy
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy (6 weeks since mitomycin, nitrosoureas, or carboplatin)
- •No progression on carboxyamidotriazole or paclitaxel
- •At least 6 months between treatment and relapse
- •Endocrine therapy:
- •At least 4 weeks since prior hormonal therapy
- •No concurrent corticosteroids except as physiologic replacement
- •Radiotherapy:
- 另有 5 项未显示
排除标准
- 未提供