A Phase II Study of Gleevec in Patients With Recurrent Platinum-Resistant, Taxane-Resistant Epithelial Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
Primary Objectives:
- To determine the efficacy of Gleevec in patients with recurrent platinum-resistant, taxane-resistant epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer whose tumor expresses either c-KIT, platelet-derived growth factor receptor (PDGRF), or ABL.
- To determine the nature and degree of toxicity of Gleevec in this cohort of patients.
详细描述
Imatinib Mesylate is a new medication that blocks several proteins important in the development of cancer. Before going on study, potential participants will have their tumor tested for c-KIT, PDGFR, and ABL for positivity. Those participants who have at least one positive biomarker will be eligible for treatment.
Before treatment starts, participants will have a complete checkup, blood tests, chest x-ray, and heart function test. Women able to have children must have a negative blood pregnancy test. A blood sample (3 teaspoons) will be taken once a week during treatment and at the end of treatment. A complete exam will also be done at the end of treatment. Tumors will be measured by computed tomography (CT) scan every 6 weeks while one study and at the end of treatment.
Participants in this study will take Imatinib Mesylate by mouth in a single dose on a daily basis. Participants will be treated for 6 weeks, which is one cycle of therapy. After 6 weeks, participants will be evaluated for side effects and tumor response. The dose may be decreased for the next cycle if participants side effects. Participants will be removed from the study if the tumor gets worse. Participants may remain on the study as long as the tumor has not gotten worse and there are no intolerable side effects.
This is an investigational study. Imatinib Mesylate has been approved for chronic myelogenous leukemia patients. However this is an investigational study of Imatinib Mesylate in patients with ovarian, tubal, or peritoneal cancer. Participants may responsible for the cost of all or part of this drug. At least 24 and as many as 74 patients will take part in this study. All will be enrolled at M. D. Anderson.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically confirmed metastatic epithelial ovarian, primary peritoneal cancer, or fallopian tube cancer previously treated with a platinum/taxane-containing regimen. Patients may have either low-grade or high-grade recurrent epithelial tumors.
- •Patients with high-grade tumors must be platinum/taxane resistant, as defined by: progression of disease while on a first-line platinum/taxane regimen or tumor progression within 6 months of completion of a platinum/taxane regimen.
- •Patients with high-grade tumors may have failed no more than 4 prior chemotherapy regimens. All taxane/platinum therapies will be counted as one regimen.
- •Patients with low-grade tumors may have failed unlimited prior therapies.
- •Patients' tumor tissue must express one or more of the following biomarkers: c-KIT, PDGFR or ABL. Positivity will be defined as 2+ or 3+ on immunohistochemical staining.
- •All patients must have measurable disease. Measurable disease is defined as lesions which can be measured by physical examination or by means of imaging techniques. Ascites and pleural effusions are not to be considered measurable disease. An elevated serum CA 125 level without associated measurable tumor is not to be considered measurable disease.
- •Patients must have a pretreatment granulocyte count (i.e., segmented neutrophils + bands) of > 1,500/Fl, a hemoglobin level of = 9.0 gm/dL and a platelet count of > 100,000/Fl.
- •Patients must have adequate renal function as documented by a serum creatinine <2.0 mg/dL.
- •Patients must have adequate hepatic function as documented by a serum bilirubin <1.5 mg/dL, regardless of whether patients have liver involvement secondary to tumor. Aspartate transaminase (SGOT) must be < 3* institutional upper limit of normal unless the liver is involved with tumor, in which case the aspartate transaminase must be < 5* institutional upper limit of normal.
- •Patients must have an estimated life expectancy of 12 weeks or greater.
- •Zubrod performance status of 0, 1, or
- •Patients must be older than age
- •Patients must have signed an approved informed consent.
排除标准
- •Patients who have previously received Gleevec.
- •Patients with any active or uncontrolled infection, including known HIV infection.
- •Patients with psychiatric disorders that would interfere with consent or follow-up.
- •Patients with a history of myocardial infarction within the previous six months or congestive heart failure requiring therapy.
- •Patients with a history of prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years.
- •Pregnant or lactating women. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- •Presence of clinically apparent central nervous system metastases or carcinomatous meningitis.
- •Patients with a history of seizures are ineligible. Patients receiving phenytoin, phenobarbital, or other antiepileptic prophylaxis are ineligible.
- •Patients with any other severe concurrent disease which in the judgment of the investigator, would make the patient inappropriate for entry into this study, including significant hepatic, renal, or gastrointestinal diseases.
- •Patients with a deep venous or arterial thrombosis (including pulmonary embolism) within 6 weeks of study entry.
- •Patients who are receiving warfarin.
研究组 & 干预措施
Imatinib Mesylate
600 mg/day orally for 6 Weeks
干预措施: Imatinib Mesylate (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 6 weeks with re-evaluation every 6 weeks or until disease progression
ORR = participant proportion with responsive disease: Complete Response (CR): disappearance all clinically detectable malignant disease for at least 4 weeks, no new lesions; Partial Response (PR): \>/= 50% decrease sum of products of perpendicular diameters of all measurable lesions for at least 4 weeks; Stable Disease: does not qualify for CR, PR or progression. Progressive Disease: a 25% or \> increase in sum of products of measurable lesions over smallest sum observed, OR reappearance of lesion which had disappeared, OR appearance of new lesion/site. Response determined every 6 week cycle.
次要结局
未报告次要终点