NCT00096239已完成2 期
Phase II Open-Label, Multi-Center Study of CP-547, 632, an Oral Tyrosine Kinase Inhibitor of VEGFR-2, in Subjects With Recurrent or Persistent Small-Volume Epithelial Ovarian Cancer, Primary Peritoneal Serous Cancer, or Fallopian Tube 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: CP-547,632 may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor.
PURPOSE: This phase II trial is studying how well CP-547,632 works in treating patients with recurrent or persistent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of CP-547,632, in terms of clinical response benefit (CA 125 response [complete response (CR) or partial response (PR)] or stable disease ≥ 16 weeks), in patients with recurrent or persistent small-volume ovarian epithelial, primary peritoneal serous, or fallopian tube cancer.
Secondary
- Determine progression-free survival of patients treated with this drug.
- Determine CA 125 response (CR or PR) rate in patients treated with this drug.
- Determine duration of CA 125 response in patients treated with this drug.
- Determine the safety of this drug in these patients.
- Correlate the steady state plasma concentration of this drug with efficacy and toxicity in these patients.
- Correlate clinical outcome with an angiogenic profile derived from measurement of serum vascular endothelial growth factor, basic fibroblast growth factor, and interleukin-8 in patients treated with this drug.
- Determine changes in the Hospital Anxiety and Depression Scale (HADS) in patients treated with this drug.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed ovarian epithelial, primary peritoneal serous, or fallopian tube cancer
- •Recurrent or persistent disease
- •Elevated CA 125, defined as ≥ 40 U/mL on 2 separate consecutive measurements taken ≥ 1 week apart
- •No definitive disease OR small-volume disease (≤ 2 cm by spiral or conventional CT scan or clinical exam)
- •Asymptomatic disease
- •PATIENT CHARACTERISTICS:
- •26 and over (age 18 to 25 allowed provided there is closure of the epiphyses on radiography)
- •Performance status
- •Life expectancy
- •More than 6 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •No bleeding disorders
- •No hemorrhage ≥ grade 2 within the past 12 months
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 2.5 times ULN
- •ALT and/or AST ≤ 2.5 times ULN
- •Albumin ≥ 3.2 g/dL
- •PT/PTT ≤ 1.5 times ULN
- •INR ≤ 1.5
- •Creatinine ≤ 1.5 times ULN OR
- •Creatinine clearance ≥ 60 mL/min
- •Cardiovascular
- •QTc ≤ 460 msec by ECG
- •No unstable angina within the past 6 months
- •No decompensated congestive heart failure within the past 6 months
- •No myocardial infarction within the past 6 months
- •No serious cardiac arrhythmias or conduction abnormalities, including any history of recurrent ventricular arrhythmia, within the past 6 months
- •No cardiomyopathy
- •No history of syncope associated with arrhythmia
- •No uncontrolled hypertension within the past 3 weeks, defined as systolic blood pressure > 150 mm Hg or diastolic blood pressure > 90 mm Hg on ≥ 2 of 3 blood pressure readings taken ≥ 5 minutes apart
- •No thrombotic cardiovascular events, including transient ischemic attacks, within the past 12 months
- •Gastrointestinal
- •Able to take oral medication
- •No malabsorption syndromes
- •No active gastrointestinal bleeding (hematemesis, hematochezia, or melena), unrelated to cancer, within the past 3 months
- •No requirement for IV alimentation
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study participation
- •No active infection
- •No uncontrolled diabetes
- •No dementia, altered mental status, or uncontrolled psychiatric illness that would preclude giving informed consent or study compliance
- •No other serious uncontrolled medical disorder that would preclude study participation
- •No other active malignancy within the past 3 years except treated limited stage basal cell or squamous cell skin cancer or carcinoma in situ of the breast or cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior exposure to mouse antibodies
- 另有 27 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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