NCT00039585已完成2 期
Phase II Clinical Trial With Proteomic Profiling Of Imatinib Mesylate (Gleevec; STI571), A PDGFR And C-Kit Inhibitor, In Patients With Refractory Or Relapsed Epithelial Ovarian Cancer, Fallopian Tube And 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
- 2
- 主要终点
- Clinical response in patients with epithelial ovarian cancer as measured by CT scan of chest, abdomen, and pelvis every 8 weeks
研究概览
简要总结
RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase II trial to determine the effectiveness of imatinib mesylate in treating patients who have refractory or relapsed ovarian epithelial, fallopian tube, or primary peritoneal cancer, or ovarian low malignant potential tumor.
详细描述
OBJECTIVES:
- Determine the clinical activity of imatinib mesylate in patients with recurrent or relapsed ovarian epithelial, fallopian tube, or primary peritoneal cancer or ovarian low malignant potential tumor.
- Correlate the biochemical modulation of signal transduction pathways downstream of platelet-derived growth factor receptor (PDGFR) and c-kit tyrosine kinases in biopsy tissue with outcome in patients treated with this drug.
- Correlate the expression of PDGFR and c-kit in both archival and fresh biopsy tissue with response and outcome in patients treated with this drug.
- Investigate the potential antiangiogenic activity of this drug in microdissected tumor cell and stromal lysates of these patients.
- Investigate the potential for collateral receptor tyrosine kinase inhibition in biopsy tissue of patients treated with this drug.
- Evaluate the application of surface-enhanced laser desorption and ionization with time-of-flight detection (SELDI-TOF) with artificial intelligence bioinformatics to serially obtained serum samples for prediction of response in these patients and/or toxicity of this drug.
OUTLINE: Patients receive oral imatinib mesylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Up to 47 patients will be accrued for this study within 12-20 months.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer OR
- •Histologically confirmed ovarian low malignant potential tumor with invasive recurrence
- •Relapsed after and/or refractory to platinum- and taxane-based chemotherapy
- •Patients in first relapse after a disease-free interval of more than 1 year are eligible
- •Measurable disease outside prior radiation field
- •Availability of a sentinel lesion that is adequate for core biopsy through percutaneous biopsy or simple laparoscopic means
- •Patients with clinical evidence of CNS involvement (abnormal clinical examination) must have a negative CT scan with contrast or MRI of the brain
- •No large volume ascites or pleural effusion
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count greater than 1,500/mm^3
- •Hemoglobin at least 9.0 g/dL (independent of epoetin alfa or transfusion)
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •Transaminases no greater than 2.5 times upper limit of normal
- •Creatinine no greater than 1.5 mg/dL
- •Cardiovascular:
- •No myocardial infarction or unstable dysrhythmia within the past 6 months
- •No congestive heart failure (CHF), including CHF that may be compensated with furosemide
- •No other invasive malignancy within the past 5 years except noninvasive nonmelanoma skin cancer
- •No active infection
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception during and for 3 months after study completion
- •Concurrent residual, stable, grade 2 or lower peripheral neuropathy allowed at the discretion of the principal investigator (PI)
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior signal transduction therapy
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or carboplatin)
- •Endocrine therapy:
- •At least 4 weeks since prior hormonal therapy
- •Radiotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy
- •See Disease Characteristics
- •Recovered from prior anticancer therapy
- •At least 1 week since prior antibiotics
- •No more than 4 prior anticancer regimens
- •No concurrent ketoconazole, itraconazole, erythromycin, or clarithromycin
- •No concurrent therapeutic warfarin
- •Patients who can be safely converted over to low molecular weight heparin are eligible
- •No concurrent grapefruit or grapefruit juice
- 另有 3 项未显示
排除标准
- 未提供
结局指标
主要结局
Clinical response in patients with epithelial ovarian cancer as measured by CT scan of chest, abdomen, and pelvis every 8 weeks
次要结局
- Collateral receptor tyrosine kinase inhibition as measured by tumor lysate microarray on biopsy tissue at baseline and at 4 weeks
- Correlation of PDGFR and c-kit expression with response and outcome in patients with epithelial ovarian cancer as measured by tumor microarray analysis on biopsy tissue at baseline and at 4 weeks
- Antiangiogenic activity as measured by tumor lysate microarray on biopsy tissue at baseline and at 4 weeks
- Prediction of response and/or toxicity as measured by Surface-Enhanced Laser Desorption/Ionization Time-Of-Flight (SELDI-TOF) proteomics and Artificial Intelligence bioinformatics on serum samples at baseline and every 4 wks
- Corr. of biochem. modulation of signal transduction pathways downstream of platelet-derived growth factor receptor (PDGFR) and c-kit tyrosine kinase by tumor lysate microarray analysis in biopsy tissue with patient outcome at baseline and at 4 wks
研究者
研究点 (2)
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