NCT00019461已完成2 期
A Phase II Trial of Orally Administered CAI for Patients With Persistent or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal 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
- 1
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 carboxyamidotriazole in treating patients with refractory or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.
详细描述
OBJECTIVES:
- Determine the clinical outcome in patients with ovarian epithelial, fallopian tube, or primary peritoneal cancer treated with carboxyamidotriazole.
OUTLINE: Patients receive oral carboxyamidotriazole daily beginning on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 19-40 patients will be accrued for this study within 2 years.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed refractory or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer
- •Measurable disease by physical exam, radiography, peritoneoscopy, or laparoscopy
- •No more than 4 weeks since prior peritoneoscopy
- •No brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 4 months
- •Hematopoietic:
- •Absolute neutrophil count at least 1,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 9.0 g/dL AND/OR
- •Hematocrit at least 27%
- •SGOT/SGPT no greater than 3 times upper limit of normal
- •Bilirubin normal
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance at least 50 mL/min
- •Cardiovascular:
- •No history of symptomatic cardiac dysrhythmias requiring medication
- •At least 6 months since prior myocardial infarction
- •No unstable or newly diagnosed angina
- •No obstructive lung disease requiring oxygen therapy
- •Not pregnant or nursing
- •HIV negative
- •Must be able to take oral medication
- •No concurrent medical condition (e.g., impending bowel obstruction)
- •No grade 2 or greater residual peripheral neuropathy
- •No active infection
- •No other prior or concurrent invasive malignancy within the past 5 years
- •No history of acute visual loss other than that associated with retinal detachment
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior cytokine therapy
- •No concurrent cytokine therapy to maintain WBC count
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, carboplatin, or mitomycin)
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •At least 4 weeks since prior hormonal therapy
- •No concurrent corticosteroids at doses greater than physiological replacement doses
- •No concurrent hormonal therapy
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy
- •No concurrent radiotherapy
- •See Disease Characteristics
- •No more than 3 prior treatment regimens
- •At least 1 week since prior systemic antibiotics for infection
- •No chronic antifungal treatment with antimycotic imidazoles
- 另有 1 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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