NCT00095914已完成1 期
Randomized, Crossover, Pharmacokinetic Study Of Paclitaxel (Taxol) And ABI-007 (A Cremophor EL-Free, Protein Stabilized, Nanoparticle Paclitaxel) In Patients With Advanced Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining paclitaxel with ABI-007 may kill more tumor cells.
PURPOSE: Randomized phase I trial to study the effectiveness of combining paclitaxel with ABI-007 in treating patients who have locally advanced or metastatic solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine whether a change in the formulation alters the pharmacokinetic profile of paclitaxel in the plasma of patients with incurable locally advanced or metastatic solid tumors treated with ABI-007 and paclitaxel.
Secondary
- Correlate pharmacokinetic data of this regimen with decrease in the neutrophil count at nadir in these patients.
- Determine the intra- and interindividual pharmacokinetic variability of ABI-007 in these patients.
- Determine protein binding of paclitaxel via measurement of α-1-acid glycoprotein and serum albumin levels in patients treated with this regimen.
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 confirmed malignant solid tumor
- •Considered incurable
- •Locally advanced or metastatic disease
- •Likely to be responsive to taxane-based therapy
- •Patients who are refractory to prior paclitaxel are ineligible
- •No symptomatic or untreated brain metastasis or carcinomatous meningitis
- •No patients who are unable to remain free of corticosteroid therapy for > 4 weeks due to CNS disease
- •No previously untreated locally advanced breast cancer
- •No hematologic malignancy
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin normal
- •ALT and AST ≤ 1.5 times upper limit of normal
- •Creatinine normal OR
- •Creatinine clearance ≥ 60 mL/min
- •Cardiovascular
- •LVEF ≥ 40%
- •No clinical signs or symptoms of heart failure
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 2 months after study participation
- •No history of allergic reaction attributed to compounds of similar chemical or biologic composition to paclitaxel (e.g., docetaxel, Cremophor^® EL [CrEL], polysorbate 80 [Tween 80], or CrEL-containing medications [e.g., cyclosporine])
- •No history of seizure disorder requiring anticonvulsant therapy
- •No active serious infection
- •No psychiatric illness or social situation that would preclude study compliance
- •No other uncontrolled illness
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent immunotherapy
- •No concurrent filgrastim (G-CSF) during courses 1 and 2
- •Chemotherapy
- •See Disease Characteristics
- •At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- •No other concurrent chemotherapy
- •Endocrine therapy
- •See Disease Characteristics
- •At least 2 weeks since prior hormonal therapy
- •Concurrent luteinizing hormone-releasing hormone agonists for prostate cancer allowed
- •Radiotherapy
- •At least 3 weeks since prior radiotherapy
- •No concurrent radiotherapy
- 另有 5 项未显示
排除标准
- 未提供
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Paclitaxel and Carboplatin With or Without Nitroglycerin in Treating Patients With Previously Untreated Stage III or Stage IV Non-Small Cell Lung CancerLung CancerNCT00616031Kyoto University150
Unknown
3 期
Paclitaxel, Carboplatin, and Radiation Therapy With or Without Adjuvant Paclitaxel and Carboplatin in Treating Patients With Stage II or Stage III Unresectable Non-Small Cell Lung CancerLung CancerNCT00077220GERCOR - Multidisciplinary Oncology Cooperative Group
已完成
2 期
Paclitaxel and Carboplatin in Treating Patients With Locally Advanced or Metastatic Renal Cell CancerKidney CancerNCT00077129Eastern Cooperative Oncology Group22
已完成
1 期
Phenoxodiol Combined With Either Cisplatin or Paclitaxel in Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal CancerPrimary Peritoneal Cavity CancerFallopian Tube CancerOvarian CancerNCT00091377MEI Pharma, Inc.65
已完成
2 期
Paclitaxel + Carboplatin With/Out Cediranib Maleate in Stage III or Stage IV Non-Small Cell Lung CancerLung CancerNCT00245154NCIC Clinical Trials Group296