Phase I Dose Finding Clinical Trial of Combination Paclitaxel, Carboplatin and Temozolomide for Subjects With Solid Tumor Malignancies.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose of Temozolomide in Combination with Fixed Doses of Paclitaxel and Carboplatin
研究概览
简要总结
The purpose of this study is to determine the maximum tolerable dose of temozolomide in combination with fixed dose of paclitaxel and carboplatin and to determine the overall tumor response rate with this combination and to determine the duration of response.
详细描述
The objective of the research study is to test a combination of drugs to treat small cell lung cancer which has spread beyond the lungs (extensive cancer) or come back after earlier treatment (recurrent cancer).
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
- •Age greater than or equal to 18 years
- •Karnofsky performance status (KPS) of greater than or equal to 70 (Appendix B)
- •Laboratory values (performed within 14 days prior to study drug administration, inclusive).
- •Absolute neutrophil count (ANC) >1500/mm3
- •Platelet count >100,000/mm3
- •Hemoglobin >10 g/dl or 100 g/l
- •BUN and serum creatinine <1.5 times upper limit of laboratory normal
- •Total and direct bilirubin <1.5 times upper limit of laboratory normal
- •SGOT and SGPT <3 times upper limit of laboratory normal
- •Alkaline Phosphatase <3 times upper limit of laboratory normal
- •A life expectancy of greater than 12 weeks
- •Subjects must give written informed consent.
- •Biopsy proven small cell lung cancer.
- •CT of chest, abdomen, pelvis and MRI of head
- •Patients with brain metastases should be asymptomatic to enter the study
排除标准
- •No recovery from all active toxicities of prior therapies.
- •Subjects who are poor medical risks because of non-malignant systemic disease as well as those with acute infection treated with intravenous antibiotics.
- •Frequent vomiting or medical condition that could interfere with oral medication intake (eg, partial bowel obstruction).
- •Concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin. Prior malignancies which have not required anti-tumor treatment within the preceding 24 months are eligible.
- •Known HIV positivity or AIDS-related illness.
- •Pregnant or nursing women.
- •Women of childbearing potential who are not using an effective method of contraception. Women of childbearing potential must have a negative serum pregnancy test 24 hours prior to administration of study drug and be practicing medically approved contraceptive precautions.
- •Men who are not advised to use an effective method of contraception.
- •Progression of disease on prior chemotherapy with paclitaxel and carboplatin, either as single agent or in combination.
- •Known hypersensitivity reaction to taxoid or platinum compound.
研究组 & 干预措施
Combination Treatment
Paclitaxel at 175 mg/m2 + Carboplatin at area under the curve (AUC) 5 on day 1. Then, Temozolomide at the doses described under "Interventions" from day 2 to day 6 (a total of 5 days).
Cycle length is 21 days.
干预措施: Combination Treatment - Cohort 1 (Drug)
Combination Treatment
Paclitaxel at 175 mg/m2 + Carboplatin at area under the curve (AUC) 5 on day 1. Then, Temozolomide at the doses described under "Interventions" from day 2 to day 6 (a total of 5 days).
Cycle length is 21 days.
干预措施: Combination Treatment - Cohort 2 (Drug)
Combination Treatment
Paclitaxel at 175 mg/m2 + Carboplatin at area under the curve (AUC) 5 on day 1. Then, Temozolomide at the doses described under "Interventions" from day 2 to day 6 (a total of 5 days).
Cycle length is 21 days.
干预措施: Combination Treatment - Cohort 3 (Drug)
Combination Treatment
Paclitaxel at 175 mg/m2 + Carboplatin at area under the curve (AUC) 5 on day 1. Then, Temozolomide at the doses described under "Interventions" from day 2 to day 6 (a total of 5 days).
Cycle length is 21 days.
干预措施: Combination Treatment - Cohort 4 (Drug)
结局指标
主要结局
Maximum Tolerated Dose of Temozolomide in Combination with Fixed Doses of Paclitaxel and Carboplatin
时间窗: 4 months
Temozolomide was administered at different dose levels (see Cohorts 1-4) until the maximum tolerated dose (MTD) was reached. MTD is the dose at which 0/6 or 1/6 patients in the cohort experience dose limiting toxicity (DLT) during the first 4 week cycle with the next higher dose having at least 2/3 or 2/6 patients experiencing DLT. DLT will have occurred when the patient has 1 or more Grade 4 hematologic or nonhematologic toxicities. A DLT must occur in the first cycle of the combination and must be at least possibly attributed to the treatment regimen. Toxicities will be graded according to the NCI CTCAE Version 3.0.
次要结局
- Tumor response rate(7 months)