A Phase II Study of Farnesyl Transferase Inhibitor R115777 (Zarnestra) (R115777 ( Zarnestra), Tipifarnib, R115777, NSC #702818) in Elderly Patients With Previously Untreated Poor-Risk Acute Myeloid Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Complete remission (CR) rate
研究概览
简要总结
Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Phase II trial to study the effectiveness of tipifarnib in treating older patients who have previously untreated acute myeloid leukemia
详细描述
PRIMARY OBJECTIVES:
I. To determine the complete response rate of R115777 (tipifarnib) in previously untreated acute myeloid leukemia (AML) in (a) elderly patients (age >= 75) and (b) patients (age >= 65) with AML preceded by myelodysplastic syndrome (MDS), using a chronic dosing schedule.
SECONDARY OBJECTIVES:
I. To determine progression-free and overall survival in patients with previously untreated AML treated with R115777, using a chronic dosing schedule.
II. To determine the duration of response in patients with previously untreated AML treated with R115777, using a chronic dosing schedule.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologic confirmation of the diagnosis of AML (>= 20% marrow blasts)
- •ECOG performance status 0 or 1
- •Patients must be able to give informed consent
- •SGOT and SGPT =< 2.5 x normal limits (grade 1)
- •Serum creatinine =< 1.5 x normal limits (grade 1)
- •AML (any of the following):
- •Newly diagnosed AML in adults >= 75 years
- •Newly diagnosed AML arising from MDS in adults >= 65 years
- •Hyperleukocytosis with >= 30,000 leukemic blasts/uL
排除标准
- •Acute promyelocytic (FAB M3) subtype
- •Previously treated with chemotherapy for leukemia (except for hydroxyurea)
- •Disseminated intravascular coagulation (laboratory or clinical)
- •Active central nervous system leukemia
- •Concomitant radiation therapy, chemotherapy, or immunotherapy; previous therapy for another malignancy is permitted, provided that at least 1 month has occurred since patient received any of these treatments
- •Intrinsic impaired organ function (as stated above)
- •Symptomatic neuropathy (grade 2 or worse)
- •Known allergy to imidazole drugs, such as ketoconazole, miconazole, econazole, teconazole, clotrimazole, fenticonazole, isoconazole, sulconazole, or ticonazole
- •Physical or psychiatric conditions that in the estimation of the principal investigator (PI) or designee place the patient at high risk of toxicity or non-compliance, e.g. severe congestive heart failure (CHF), unstable angina, or poorly controlled psychosis
研究组 & 干预措施
Treatment (tipifarnib)
Patients receive oral tipifarnib twice daily on days 1-21. Patients with a complete or partial response, hematologic improvement, or stable disease continue treatment every 29-63 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response after the second course of therapy receive 2 additional courses of therapy.
干预措施: tipifarnib (Drug)
Treatment (tipifarnib)
Patients receive oral tipifarnib twice daily on days 1-21. Patients with a complete or partial response, hematologic improvement, or stable disease continue treatment every 29-63 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response after the second course of therapy receive 2 additional courses of therapy.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Complete remission (CR) rate
时间窗: Up to 8 years
CR rates will be calculated with 95% confidence intervals for each age group separately.
次要结局
- Partial remission (PR) rate(Up to 8 years)
- Toxicity rates assessed using NCI CTCAE version 3.0(Up to 8 years)
- Duration of response(From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 8 years)
- Duration of survival(From time of enrollment onto this study to the time of death, assessed up to 8 years)