Phase II Study of Imatinib Mesylate and Docetaxel in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Participant Response Rate
研究概览
简要总结
Primary Objective:
- To determine the efficacy of the combination of imatinib mesylate and docetaxel in recurrent or metastatic head and neck squamous cell cancer by serial measurements of tumor response (extent, frequency, duration).
Secondary Objectives:
- To assess the safety and tolerability of imatinib mesylate and docetaxel in patients with recurrent or metastatic head and neck squamous cell cancer.
- To explore the biologic effects of imatinib mesylate and docetaxel on tumor tissue by immunohistochemical analysis of microvessel density and phosphorylation of Platelet-derived growth factor receptors (PDGF-R).
- To explore the effects of imatinib mesylate and docetaxel on surrogate markers in serum.
- To assess the rate of survival.
详细描述
Imatinib mesylate is designed to block certain proteins important in the growth of cancer. Docetaxel is designed to target and destroy cancer cells.
If you are found to be eligible to take part in this study, you will take 4 imatinib mesylate tablets by mouth once a day with a meal and a large glass of water (about 8-10 ounces.) A treatment cycle on this study is 21 days. You should keep normal eating habits, however a low-fat breakfast is recommended (for example, a light continental breakfast of toast and juice). Foods and drinks containing caffeine or grapefruit should be avoided. You should wait at least 1 hour after taking the last tablet before going to bed. If vomiting occurs, do not take any extra study medication.
You will be given a patient diary to record when you take your medication. You should bring the diary to each clinic visit, and the study nurse will review it each time.
Docetaxel will be given through a vein in your arm on the first day of each 21-day treatment cycle for a total of 6 cycles. The infusion will take 1 hour.
You will need to take steroids (dexamethasone) before receiving docetaxel to try to prevent fluid accumulation and allergic reactions. You will take dexamethasone by mouth twice a day on the day before the docetaxel infusion, the day of the infusion, and the day after infusion. You will receive an extra dose of dexamethasone (either through a needle in a vein or by mouth) on the day of infusion of the chemotherapy either through a needle in a vein or by mouth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •A written, voluntary informed consent form must be completed prior to beginning any study procedure.
- •Patients >/= 18 years of age.
- •Histologically documented diagnosis of head and neck squamous cell cancer
- •At least one measurable site of disease and can be assessed by Response Evaluation Criteria In Solid Tumors (RECIST).
- •Performance status 0-2 (Eastern Cooperative Oncology Group, ECOG)
- •Patients must have adequate hepatic, renal, and bone marrow function, defined as the following: (1) total bilirubin < 1.5 * Upper Limits of Normal (ULN); (2) aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) < 2.5 * ULN; (3) creatinine < 1.5 * ULN; (4) ANC > 1.5 * 10^9/L; (5) platelets > 100 * 10^9/L.
- •Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control (i.e. condoms, diaphragm) throughout the study and for up to 3 months following discontinuation of study drug.
- •Patients who have not been treated for recurrent or metastatic head and neck squamous cell carcinomas (HNSCC) (i.e. Patients who have been treated with chemotherapy for induction/adjuvant or concurrent therapy with radiation in the setting of definitive treatment but have now developed recurrent or metastatic disease are eligible).
排除标准
- •Prior exposure to docetaxel or imatinib mesylate.
- •Patient has received any other investigational agents within 30 days of first day of study drug dosing.
- •Patients with myocardial infarction within the past 6 months or New York Heart Association class 3 or 4 congestive heart failure.
- •Female patients who are pregnant or breast-feeding.
- •Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection (i.e. septic).
- •Patient has unstable brain metastasis. Unstable brain metastasis is defined as patients on steroid medication to control symptoms or patient with motor neurologic compromise due to brain metastasis. Patients with treated brain metastasis are eligible if they are > 6 weeks out from therapy and off all steroid medication.
- •Patient has known chronic liver disease (i.e., chronic active hepatitis or cirrhosis).
- •Patient has a known diagnosis of human immunodeficiency virus (HIV) infection. HIV patients are at much greater risk of infection when receiving highly myelosuppressive agents (docetaxel and imatinib) and for safety reasons are not eligible for this trial.
- •Patient received chemotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin-C) prior to study entry, unless the disease is rapidly progressing.
- •Patient previously received radiotherapy to >/= 25 % of the bone marrow
- •Patient had a major surgery within 2 weeks prior to study entry.
- •Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
- •Patients must agree not to use herbal remedies or other over-the-counter biologics (i.e. shark cartilage)
- •History of hypersensitivity to docetaxel or other taxane therapy.
- •History of severe hypersensitivity reaction to drugs formulated with polysorbate
- •Patients taking therapeutic levels of warfarin. However, patients receiving 1 mg daily for catheter related anticoagulation are eligible for the study.
- •Prior pericardial effusion requiring intervention such as pericardiocentesis or pericardial window within 2 months of study entry.
- •Patient is < 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.
- •Patients with a history of Regional Ileitis, Colitis, or Crohn's disease, or any other relevant medical history related to the integrity of the bowel wall as there may be an increased risk of bowel perforation with the combination of Docetaxel and Imatinib.
研究组 & 干预措施
Imatinib Mesylate + Docetaxel
Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks
干预措施: Imatinib Mesylate (Drug)
Imatinib Mesylate + Docetaxel
Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks
干预措施: Docetaxel (Drug)
结局指标
主要结局
Participant Response Rate
时间窗: At 6 weeks reconfirmed 6 weeks later
Response rate to regimen defined as the number of complete or partial response divided by the total number of participants treated. Tumor response defined by Response Evaluation Criteria In Solid Tumors (RECIST). All complete and partial responses confirmed by a second assessment six weeks later.
次要结局
未报告次要终点