NCT00002972已完成2 期
Phase II Study on TAXOL in Bronchioalveolar Carcinoma
European Organisation for Research and Treatment of Cancer - EORTC10 个研究点 分布在 6 个国家目标入组 25 人开始时间: 1997年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 10
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have unresectable stage IIIB, stage IV or recurrent lung cancer.
详细描述
OBJECTIVES:
- Assess the therapeutic activity of paclitaxel in patients with bronchoalveolar carcinoma (BAC).
- Assess the duration of response in patients presenting with an objective response.
- Characterize the acute side effects of paclitaxel in patients with BAC.
- Assess the role of some biological parameters in the natural history and the response to therapy of BAC; evaluate the expression of Ki67, p53, and K-ras mutation.
OUTLINE: This is an open label, nonrandomized, multicenter study.
Paclitaxel is administered every 3 weeks as a 3 hour continuous infusion in dextrose or normal saline. Patients are treated for a minimum of 2 cycles unless serious toxicity or complication occur.
Disease is assessed every 6 weeks until documented progression; treatment side effects are assessed separately for each cycle of therapy. Treatment is given up to a maximum of 6 cycles of therapy or until disease progression, unacceptable toxicity, or patient refusal occurs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven bronchoalveolar carcinoma (BAC) based on these criteria:
- •Absence of primary adenocarcinoma elsewhere
- •Absence of a demonstrable central bronchogenic origin
- •A peripheral location in the lung parenchyma
- •Intact interstitial framework of the lung
- •A histological appearance setting it apart from other tumors, with a characteristic pattern of growth: cuboidal or cylindrical cells lining up the alveolar septa with preservation of basic pulmonary architecture
- •Must be unresectable Stage IIIB, IV, or recurrent BAC
- •Evidence of multinodular lesions involving the lungs bilaterally or unilaterally (in the latter the lesions must involve more than one lobe)
- •At least one target lesion bidimensionally measurable that has not undergone prior irradiation
- •No CNS disease
- •PATIENT CHARACTERISTICS:
- •18 to 75 (inclusive)
- •Performance status:
- •Life expectancy:
- •Greater than 3 months
- •Hematopoietic:
- •ANC at least 1,500/mm^3
- •Bilirubin less than 2 times upper limit of normal
- •SGOT, SGPT, and alkaline phosphatase less than 2 times upper limit of normal
- •Creatinine less than 1.5 times upper limit of normal
- •Cardiovascular:
- •No history of ischemic or congestive heart disease
- •No arrhythmia requiring chronic cardiopulmonary medications
- •No history of clinically or electrographically documented myocardial infarction
- •No preexisting motor or other serious sensory neurotoxicity
- •No active or prior second primary cancer except basal cell carcinoma of the skin or carcinoma in situ of the cervix
- •No clinical evidence of uncontrolled infection
- •Not pregnant or nursing
- •Negative pregnancy test 72 hours prior to start of study medication
- •Adequate contraception required of all fertile patients
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 4 weeks since radiotherapy
- •Must have at least one bidimensional lesion outside the irradiated fields
- •Fully recovered from any prior major surgery
排除标准
- 未提供
研究者
研究点 (10)
Loading locations...
相似试验
已完成
2 期
Paclitaxel in Treating Patients With Metastatic or Recurrent Salivary Gland CancerHead and Neck CancerNCT00002632Eastern Cooperative Oncology Group32
Unknown
1 期
Addition of Paclitaxel to High-Dose Combination Chemotherapy in Treating Women With Metastatic Breast CancerBreast CancerNCT00002628St. Louis University50
Unknown
1 期
Addition of Paclitaxel to High-Dose Combination Chemotherapy in Treating Patients With High-Risk Breast CancerBreast CancerNCT00002627St. Louis University30
已完成
1 期
Paclitaxel and Radiation Therapy Plus Chemoprotection With Amifostine in Treating Patients With Stage III or Stage IV Head and Neck CancerHead and Neck CancerOral ComplicationsNCT00003193Massachusetts General Hospital37
已完成
2 期
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung CancerLung CancerNCT00006378Case Comprehensive Cancer Center5