NCT00004008已完成2 期
A Phase II Trial of Bryostatin 1 in Ovarian Cancer Administered by Weekly 24 Hour Intravenous Infusion
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 8
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have ovarian epithelial cancer that has not responded to previous chemotherapy.
详细描述
OBJECTIVES:
- Evaluate the antitumor activity and toxicity of bryostatin 1 in patients with platinum resistant ovarian epithelial cancer.
- Determine the response rate in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive bryostatin 1 IV over 24 hours. Treatment repeats weekly for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable or regressive disease may receive additional treatment.
Patients are followed for at least 4 weeks after treatment, then every 3 months.
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 proven ovarian epithelial cancer
- •Progressive disease during or after completion of at least one platinum based chemotherapy regimen
- •Bidimensionally measurable disease
- •At least 2 cm by x-ray, CT scan, or ultrasound
- •No active, symptomatic brain metastases (e.g., cerebral edema and/or progressive tumor growth)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Hemoglobin at least 10 g/dL
- •WBC at least 4,000/mm3
- •Platelet count at least 100,000/mm3
- •Bilirubin no greater than 1.7 mg/dL
- •AST/ALT no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present)
- •Creatinine no greater than 1.4 mg/dL
- •No active, uncontrolled infection
- •No nonmalignant systemic disease which would increase risk to patient
- •No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 2 months after study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior immunotherapy and recovered
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) and recovered
- •No more than 2 prior multidrug chemotherapy regimens
- •No more than 1 prior single agent chemotherapy regimen
- •Endocrine therapy:
- •At least 4 weeks since prior endocrine therapy and recovered
- •No concurrent steroids
- •Concurrent hormone replacement therapy allowed
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy (excluding palliative therapy) and recovered
- •No concurrent radiotherapy
- •At least 4 weeks since prior major thoracic or abdominal surgery
- •No other concurrent anticancer therapy or investigational drugs
排除标准
- 未提供
研究者
研究点 (8)
Loading locations...
相似试验
已完成
2 期
Bryostatin 1 in Treating Patients With Stage IV Breast CancerBreast CancerNCT00003205University of Colorado, Denver
已完成
2 期
Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach CancerGastric CancerEsophageal CancerNCT00006081M.D. Anderson Cancer Center37
已完成
2 期
Bryostatin 1 and Cytarabine in Treating Patients With Relapsed Acute Myelogenous LeukemiaLeukemiaNCT00017342Virginia Commonwealth University
已完成
2 期
Bryostatin 1 in Treating Patients With Recurrent or Refractory Hodgkin's DiseaseLymphomaNCT00003936Barbara Ann Karmanos Cancer Institute
已完成
2 期
Bryostatin 1 in Treating Patients With Myelodysplastic SyndromeMyelodysplastic SyndromesLeukemiaNCT00003171Barbara Ann Karmanos Cancer Institute