NCT00005599已完成2 期
Phase II Trail of Bryostatin-1 and Paclitaxel in Patients With Advanced Esophageal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 3
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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 and paclitaxel in treating patients who have locally advanced or metastatic esophageal cancer or stomach cancer.
详细描述
OBJECTIVES:
- Determine the complete and partial response rates in patients with unresectable or metastatic esophageal cancer or carcinoma of the gastroesophageal junction treated with sequential paclitaxel and bryostatin 1.
- Determine the toxicity of this regimen in this patient population.
- Determine the survival of patients after treatment with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Examine pre- and post-treatment tissue biopsies for markers of apoptosis in selected patients.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 1 hour on day 1 and bryostatin 1 IV over 24 hours on day 2 weekly for 2 weeks. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
Quality of life is assessed at baseline, after courses 1 and 2, and then after every 2 courses thereafter.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or carcinoma of the gastroesophageal (GE) junction
- •If tumor extends below GE junction into the proximal stomach, 50% of the tumor must involve the esophagus or GE junction
- •No gastric cancer with only a minor involvement of GE junction or distal esophagus
- •Locally advanced and considered surgically unresectable or metastatic
- •Measurable disease
- •Accurately measured in at least 1 dimension as at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan
- •No truly nonmeasurable lesions only:
- •Bone lesions
- •Leptomeningeal disease
- •Pleural/pericardial effusions
- •Inflammatory breast disease
- •Lymphangitis cutis/pulmonis
- •Abdominal masses not confirmed and followed by imaging techniques
- •Cystic lesions
- •No brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Granulocyte count at least 1,500/mm^3
- •Platelet count at least 150,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •Creatinine no greater than 1.5 mg/dL
- •Cardiovascular:
- •No history of active angina
- •No myocardial infarction within the past 6 months
- •No history of significant ventricular arrhythmia requiring medication with antiarrhythmics
- •Well-controlled atrial fibrillation on standard management allowed
- •DLCO at least 60%
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 2 months after study participation
- •No preexisting neurotoxicity of grade 3 or greater
- •No serious concurrent infection or nonmalignant medical illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
- •No concurrent psychiatric disorders that would preclude study compliance
- •No other active malignancy within the past 5 years except:
- •Nonmelanoma skin cancer
- •Carcinoma in situ of the cervix
- •History of T1a or b prostate cancer (detected incidentally at transurethral resection of prostate [TURP] and comprising less than 5% of resected tissue) provided prostate-specific antigen remained normal since TURP removal
- •HIV negative
- •No other concurrent medical condition that would preclude study therapy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent immunotherapy
- •Chemotherapy:
- •Recovered from prior chemotherapy
- 另有 11 项未显示
排除标准
- 未提供
研究者
研究点 (3)
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