NCT00277082已完成不适用
Pharmacology Study of Aerosolized Liposomal 9-Nitro-20 (S)- Camptothecin (L9NC) in Patients With Metastatic or Recurrent Cancer of the Endometrium or the Lung (NSCLC)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
研究概览
简要总结
To determine the concentration of 9-nitrocamptothecin (9NC) in the alveolar fluid over time.
1.2. To determine the arterial concentration of 9NC administered by inhalation in comparison to venous and urine concentrations.
1.3. To determine the tumor concentration of 9NC administered by inhalation
详细描述
TREATMENT PLAN (25-28) Patients will be admitted to the GCRC for 25 hours.
Admission will be prior to the daily DLPC-9NC administration
Upon admission, patients will be asked to empty their bladder. Urine will be collected for 24 hours, and refrigerated. Upon completion of the collection, urine will be mixed, and a 20 ml aliquot frozen and preserved for further analysis.
A catheter will be placed in a peripheral vein, and in a peripheral artery, and appropriately heparinized.
Venous and arterial blood samples (7 ml per samples) will be drawn in heparinized green tops prior to DLPC-9NC administration, and at the following time points: 2, 5, 8, 12, and 24 hours. An additional 2 samples may be drawn at the PI discretion. (Total blood drawn: 84 ml + 14 ml)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •All patients, 18 years of age or older, with metastatic and/or recurrent endometrial cancer or with mixed mesenchymal malignant tumors whose epithelial component is recurring, who have failed standard chemotherapy or hormonal regimens for their disease or who refuse recommended standard chemotherapy are eligible.
- •Patients must have a life expectancy of at least 12 weeks.
- •Patients much have a Zubrod performance status of 0-
- •Patients must sign an informed consent.
- •Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of >= 1,500 or cells/mm³ and platelet count > 100,000/mm³ and absence of a regular red blood cell transfusion requirement.
- •Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and SGOT or SGPT < two times the upper limit of normal, and adequate renal function as defined by a serum creatinine <= 1.5 x upper limit of normal.
- •Patients must not have a known symptomatic respiratory disease other than cancer, and must have a pulmonary function test equal to >= 50% FEV1, >= 50% FEV1/FVC, >= 50% TLC, and >= 50% DLCO of predicted values.
排除标准
- •Patients with symptomatic brain metastases are excluded from this study.
- •Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
- •Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
- •Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
- •Any criteria that is borderline and may lead to ineligibility will be reviewed by the PI, who may override the eligibility criteria, after receiving sponsor agreement, if entry into the study is deemed to potentially benefit the patient.
- •Inclusion Criteria:
- •All patients, 18 years of age or older, with stage 3b, 4, or recurrent, nonresectable, non-small-cell lung carcinoma are eligible.
- •Patients must have a life expectancy of at least 12 weeks.
- •Patients must have a Zubrod performance status of 0-
- •Patients must sign an informed consent.
- •Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and SGOT or SGPT < two times the upper limit of normal, and adequate renal function as defined by a serum creatinine <= 1.5 x upper limit of normal.
- •Patients must not have a known symptomatic respiratory disease other than cancer, and must have a pulmonary function test equal to >= 50% FEV1, >= 50% FEV1/FVC, >= 50% TLC, and >= 50% DLCO of predicted values.
- •Exclusion Criteria:
- •Patients with symptomatic brain metastases are excluded from this study.
- •Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
- •Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
- •Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
- •Any criteria that is borderline and may lead to ineligibility will be reviewed by the PI, who may override the eligibility criteria, after receiving sponsor agreement, if entry into the study is deemed to potentially benefit the patient.
研究者
研究点 (1)
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