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Lenalidomide and Docetaxel in Treating Patients With Advanced Solid Tumors

2010年6月10日 更新者:Case Comprehensive Cancer Center

Phase I Trial of Daily Lenalidomide (CC-5013, Revlimid™) and Docetaxel Given Every Three Weeks in Patients With Advanced Solid Tumors

RATIONALE: Lenalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with docetaxel may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide when given together with docetaxel in treating patients with advanced solid tumors.

研究概览

详细说明

OBJECTIVES:

Primary

  • Determine the dose-limiting toxicity and maximum tolerated dose of lenalidomide when given in combination with docetaxel in patients with advanced solid tumors.

Secondary

  • Determine the safety of this regimen in these patients.
  • Determine the objective tumor response in patients treated with this regimen.
  • Determine the time to progression in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of lenalidomide.

Patients receive oral lenalidomide on days 1-14 and docetaxel IV over 1 hour on day 1. Courses repeat every 21 days until disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of lenalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

研究类型

介入性

注册 (实际的)

33

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ohio
      • Cleveland、Ohio、美国、44106-5065
        • Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS:

  • Histologically confirmed solid tumor

    • Advanced disease
    • Refractory to standard therapy OR no standard therapy exists
  • Measurable or evaluable disease
  • No active brain metastases

    • Previously treated (e.g., surgery or radiotherapy) brain metastases are allowed provided they are currently asymptomatic and inactive by CT scan or MRI

PATIENT CHARACTERISTICS:

Performance status

  • ECOG 0-2

Life expectancy

  • At least 4 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8 g/dL

Hepatic

  • Bilirubin normal
  • Meets 1 of the following criteria:

    • Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
    • AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
    • AP ≤ 5 times ULN AND AST or ALT normal

Renal

  • Creatinine ≤ 2 mg/dL

Cardiovascular

  • No New York Heart Association class III or IV heart disease

Immunologic

  • No prior desquamating rash or ≥ grade 2 allergic reaction while receiving thalidomide
  • No history of hypersensitivity to docetaxel or other drugs formulated in polysorbate 80
  • No history of allergic reaction to compounds of similar chemical or biologic composition to study drugs

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other uncontrolled illness or other condition that would preclude study compliance
  • No peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent hematopoietic growth factors during course 1 of study treatment
  • No concurrent immunotherapy

Chemotherapy

  • At least 6 weeks since prior mitomycin or nitrosoureas

    • No more than 2 prior courses of mitomycin
  • No other concurrent chemotherapy

Radiotherapy

  • No prior pelvic radiotherapy

Other

  • At least 4 weeks since prior anticancer therapy
  • No concurrent warfarin for anticoagulation (heparin is allowed)
  • Recovered from all prior treatment
  • No other concurrent anticancer therapy except bisphosphonates
  • No other concurrent investigational agents

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Maximum tolerated dose
大体时间:measured at end of phase I
measured at end of phase I
Dose-limiting toxicity
大体时间:measured after every course
measured after every course

次要结果测量

结果测量
大体时间
Disease response
大体时间:measured after every 2 courses
measured after every 2 courses

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Matthew M. Cooney, MD、Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2005年6月1日

初级完成 (实际的)

2008年1月1日

研究完成 (实际的)

2008年6月1日

研究注册日期

首次提交

2005年11月11日

首先提交符合 QC 标准的

2005年11月11日

首次发布 (估计)

2005年11月15日

研究记录更新

最后更新发布 (估计)

2010年6月11日

上次提交的符合 QC 标准的更新

2010年6月10日

最后验证

2010年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • CASE2Y04 (其他标识符:Case Comprehensive Cancer Center)
  • P30CA043703 (美国 NIH 拨款/合同)
  • AVENTIS-CASE-2Y04
  • CELGENE-CASE-2Y04

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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