A Pilot Phase II Study of Erlotinib for the Treatment of Patients With Refractory/Relapsed AML
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Participants With a Response
研究概览
简要总结
This pilot phase II trial studies how well erlotinib hydrochloride works in treating patients with relapsed or refractory acute myeloid leukemia. Erlotinib hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
详细描述
PRIMARY OBJECTIVES:
I. To assess the efficacy of erlotinib (erlotinib hydrochloride) in patients with refractory or relapsed acute myeloid leukemia (AML).
II. To determine the safety and tolerability of erlotinib in this patient population.
SECONDARY OBJECTIVES:
I. To investigate inhibitory effect of this drug on spleen tyrosine kinase (SYK) and its down-stream targets such as mitogen-activated protein kinase 8 (JNK), mitogen-activated protein kinase (MAPK) and mitogen-activated protein kinase 1 (Erk).
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with AML who have either been refractory to prior therapy or have relapsed after prior therapy; patients with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) who received therapy with a hypomethylating agent and progress to AML are eligible if they have received any therapy for MDS and failed (i.e., lack or loss of response) regardless of whether they have received therapy for AML or not; the World Health Organization (WHO) classification will be used for AML
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- •Total bilirubin =< 2 x upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) =< 2.5 x ULN
- •Creatinine =< 2 x ULN
- •Patients must provide written informed consent
- •Patients must have been off chemotherapy for 2 weeks prior to entering this study, unless there is evidence of rapidly progressive disease, and must have recovered from the clinically significant toxic effects of that therapy to at least grade 1; use of hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and for the first four weeks on therapy
- •Patients-both males and females-with reproductive potential (i.e., menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study; women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to initiation of study
排除标准
- •Patients with known allergy or hypersensitivity to erlotinib
- •Patients with any other known disease (except carcinoma in-situ) concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure New York Heart Association [NYHA] class III or IV, myocardial infarction within 6 months, and poorly controlled hypertension; chronic renal failure; or active uncontrolled infection) which, in the opinion of the investigator could compromise participation in the study
- •Patients unwilling or unable to comply with the protocol
- •Significant gastrointestinal disorders that may interfere with absorption of erlotinib
- •Patients who can receive a stem cell transplant within 4 weeks
研究组 & 干预措施
Treatment (erlotinib hydrochloride)
Patients receive erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Erlotinib Hydrochloride (Drug)
Treatment (erlotinib hydrochloride)
Patients receive erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Participants With a Response
时间窗: Up to 3 months post-treatment
Overall Response is complete remission (CR) + CR with incomplete hematologic recovery (CRi) + Partial remission (PR) + Hematologic improvement (HI) + Morphologic Leukemia-Free State (MLF). (CR) is Bone marrow; \</=5% blasts, no Auer rods or extramedullary disease and peripheral blood counts \>/= 1.0x10\^9/L Neutrophils, \>/= 100x10\^9/L platelets and no circulating blasts. (CRi), same as CR for bone marrow and \<1.0x10\^9/L neutrophils and \< 100x10\^9/L platelets in peripheral blood counts. PR is all CR criteria if abnormal prior to treatment except \>/= 50%reduction in bone marrow blast but still \> 5%. MLF is \</=5% myeloblasts on bone marrow . HI response must be described by the number of positively affected cell lines..
Overall Survival
时间窗: Up to 97 weeks
Time from date of treatment start until date of death due to any cause or last Follow-up.
Incidence of Clinically Significant, Non-hematologic Grade 3 or 4 Toxicities at Least Possibly Related to Erlotinib Hydrochloride
时间窗: Up to 30 days
Safety summaries will include tabulations in the form of tables and listings. The number of participants affected by treatment-emergent adverse events will be reported.
Event-free Survival
时间窗: Up to 21 weeks
Time from date of treatment start until the date of first objective documentation of disease-relapse.
次要结局
- Biomarker Expressions(Up to 30 days)