此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

S9716: Combination Chemotherapy in Treating Patients With Merkel Cell Cancer

2012年10月5日更新者：Southwest Oncology Group

A Phase II Trial of Cyclophosphamide, Methotrexate and 5-Fluorouracil (CMF) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining cyclophosphamide, methotrexate, and fluorouracil in treating patients with Merkel cell cancer.

研究概览

地位

完全的

条件

皮肤神经内分泌癌

干预/治疗

详细说明

OBJECTIVES: I. Investigate the ability of the Southwest Oncology Group Melanoma Committee to enroll patients with unresectable Merkel cell carcinoma that is local-regional or metastatic. II. Determine the overall survival rate and objective response rate of these patients after treatment with cyclophosphamide, methotrexate, and fluorouracil.

OUTLINE: Patients are stratified according to local-regional disease versus metastatic disease. Patients receive cyclophosphamide IV, methotrexate IV, and fluorouracil IV on day 1. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicities. Patients are followed every 6 months for 2 years, then annually thereafter.

PROJECTED ACCRUAL: A total of 80 patients (40 patients per stratum) will be accrued for this study.

研究类型

介入性

注册 (实际的)

阶段

阶段2

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

美国
- Alabama
  - Mobile、Alabama、美国、36688
    - MBCCOP - University of South Alabama
- Arizona
  - Phoenix、Arizona、美国、85006-2726
    - CCOP - Greater Phoenix
  - Phoenix、Arizona、美国、85012
    - Veterans Affairs Medical Center - Phoenix (Hayden)
  - Tucson、Arizona、美国、85724
    - Arizona Cancer Center
  - Tucson、Arizona、美国、85723
    - Veterans Affairs Medical Center - Tucson
- Arkansas
  - Little Rock、Arkansas、美国、72205
    - University of Arkansas for Medical Sciences
  - Little Rock、Arkansas、美国、72205
    - Veterans Affairs Medical Center - Little Rock (McClellan)
- California
  - Long Beach、California、美国、90822
    - Veterans Affairs Medical Center - Long Beach
  - Los Angeles、California、美国、90033-0800
    - USC/Norris Comprehensive Cancer Center
  - Los Angeles、California、美国、90095-1781
    - Jonsson Comprehensive Cancer Center, UCLA
  - Los Angeles、California、美国、91010
    - Beckman Research Institute, City of Hope
  - Martinez、California、美国、94553
    - Veterans Affairs Outpatient Clinic - Martinez
  - Oakland、California、美国、94609-3305
    - CCOP - Bay Area Tumor Institute
  - Sacramento、California、美国、95817
    - University of California Davis Medical Center
  - San Francisco、California、美国、94115-0128
    - UCSF Cancer Center and Cancer Research Institute
  - Santa Rosa、California、美国、95403
    - CCOP - Santa Rosa Memorial Hospital
  - Travis Air Force Base、California、美国、94535
    - David Grant Medical Center
- Colorado
  - Denver、Colorado、美国、80220
    - Veterans Affairs Medical Center - Denver
  - Denver、Colorado、美国、80262
    - University of Colorado Cancer Center
- Georgia
  - Atlanta、Georgia、美国、30342-1701
    - CCOP - Atlanta Regional
  - Fort Gordon、Georgia、美国、30905-5650
    - Dwight David Eisenhower Army Medical Center
- Hawaii
  - Honolulu、Hawaii、美国、96813
    - Cancer Research Center of Hawaii
- Illinois
  - Decatur、Illinois、美国、62526
    - CCOP - Central Illinois
  - Hines、Illinois、美国、60141
    - Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
  - Maywood、Illinois、美国、60153
    - Loyola University Medical Center
- Kansas
  - Kansas City、Kansas、美国、66160-7357
    - University of Kansas Medical Center
  - Wichita、Kansas、美国、67214-3882
    - CCOP - Wichita
  - Wichita、Kansas、美国、67218
    - Veterans Affairs Medical Center - Wichita
- Kentucky
  - Lexington、Kentucky、美国、40511-1093
    - Veterans Affairs Medical Center - Lexington
  - Lexington、Kentucky、美国、40536-0084
    - Albert B. Chandler Medical Center, University of Kentucky
- Louisiana
  - New Orleans、Louisiana、美国、70112
    - Tulane University School of Medicine
  - New Orleans、Louisiana、美国、70112
    - MBCCOP - LSU Medical Center
  - New Orleans、Louisiana、美国、70112
    - Veterans Affairs Medical Center - New Orleans
  - Shreveport、Louisiana、美国、71130-3932
    - Louisiana State University Health Sciences Center - Shreveport
  - Shreveport、Louisiana、美国、71130
    - Veterans Affairs Medical Center - Shreveport
- Massachusetts
  - Boston、Massachusetts、美国、02118
    - Boston Medical Center
  - Jamaica Plain、Massachusetts、美国、02130
    - Veterans Affairs Medical Center - Boston (Jamaica Plain)
- Michigan
  - Ann Arbor、Michigan、美国、48109-0752
    - University of Michigan Comprehensive Cancer Center
  - Ann Arbor、Michigan、美国、48105
    - Veterans Affairs Medical Center - Ann Arbor
  - Detroit、Michigan、美国、48201
    - Barbara Ann Karmanos Cancer Institute
  - Detroit、Michigan、美国、48202
    - Henry Ford Hospital
  - Detroit、Michigan、美国、48201-1932
    - Veterans Affairs Medical Center - Detroit
  - Grand Rapids、Michigan、美国、49503
    - CCOP - Grand Rapids Clinical Oncology Program
  - Southfield、Michigan、美国、48075-9975
    - Providence Hospital - Southfield
- Mississippi
  - Biloxi、Mississippi、美国、39531-2410
    - Veterans Affairs Medical Center - Biloxi
  - Jackson、Mississippi、美国、39216-4505
    - University of Mississippi Medical Center
  - Jackson、Mississippi、美国、39216
    - Veterans Affairs Medical Center - Jackson
  - Keesler AFB、Mississippi、美国、39534-2576
    - Keesler Medical Center - Keesler AFB
- Missouri
  - Kansas City、Missouri、美国、64128
    - Veterans Affairs Medical Center - Kansas City
  - Kansas City、Missouri、美国、64131
    - CCOP - Kansas City
  - Saint Louis、Missouri、美国、63110-0250
    - St. Louis University Health Sciences Center
  - Saint Louis、Missouri、美国、63141
    - CCOP - St. Louis-Cape Girardeau
  - Springfield、Missouri、美国、65807
    - CCOP - Cancer Research for the Ozarks
- Montana
  - Billings、Montana、美国、59101
    - CCOP - Montana Cancer Consortium
- New Mexico
  - Albuquerque、New Mexico、美国、87108-5138
    - Veterans Affairs Medical Center - Albuquerque
  - Albuquerque、New Mexico、美国、87131
    - MBCCOP - University of New Mexico HSC
- New York
  - Brooklyn、New York、美国、11209
    - Veterans Affairs Medical Center - Brooklyn
  - New York、New York、美国、10032
    - Herbert Irving Comprehensive Cancer Center
- Ohio
  - Cincinnati、Ohio、美国、45219
    - Barrett Cancer Center, The University Hospital
  - Cincinnati、Ohio、美国、45220-2288
    - Veterans Affairs Medical Center - Cincinnati
  - Cleveland、Ohio、美国、44195
    - Cleveland Clinic Cancer Center
  - Columbus、Ohio、美国、43206
    - CCOP - Columbus
  - Dayton、Ohio、美国、45428
    - Veterans Affairs Medical Center - Dayton
  - Kettering、Ohio、美国、45429
    - CCOP - Dayton
- Oklahoma
  - Oklahoma City、Oklahoma、美国、73104
    - Oklahoma Medical Research Foundation
  - Oklahoma City、Oklahoma、美国、73104
    - Veterans Affairs Medical Center - Oklahoma City
- Oregon
  - Portland、Oregon、美国、97201-3098
    - Oregon Cancer Center at Oregon Health Sciences University
  - Portland、Oregon、美国、97207
    - Veterans Affairs Medical Center - Portland
  - Portland、Oregon、美国、97213
    - CCOP - Columbia River Program
- South Carolina
  - Greenville、South Carolina、美国、29615
    - CCOP - Greenville
  - Spartanburg、South Carolina、美国、29303
    - CCOP - Upstate Carolina
- Texas
  - Fort Sam Houston、Texas、美国、78234
    - Brooke Army Medical Center
  - Galveston、Texas、美国、77555-1329
    - University of Texas Medical Branch
  - Lubbock、Texas、美国、79423
    - Texas Tech University Health Science Center
  - San Antonio、Texas、美国、78284-7811
    - University of Texas Health Science Center at San Antonio
  - San Antonio、Texas、美国、78284
    - Veterans Affairs Medical Center - San Antonio (Murphy)
  - Temple、Texas、美国、76504
    - Veterans Affairs Medical Center - Temple
  - Temple、Texas、美国、76508
    - CCOP - Scott and White Hospital
- Utah
  - Salt Lake City、Utah、美国、84132
    - Huntsman Cancer Institute
  - Salt Lake City、Utah、美国、84148
    - Veterans Affairs Medical Center - Salt Lake City
- Washington
  - Seattle、Washington、美国、98101
    - CCOP - Virginia Mason Research Center
  - Seattle、Washington、美国、98104
    - Swedish Cancer Institute
  - Seattle、Washington、美国、98108
    - Veterans Affairs Medical Center - Seattle
  - Tacoma、Washington、美国、98405-0986
    - CCOP - Northwest

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

不

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS: Histologically proven unresectable Merkel cell carcinoma Local-regional OR Metastatic Bidimensionally measurable disease If all known sites previously irradiated, disease must be progressive CNS metastases allowed if not only site of measurable disease No pleural effusions or ascites

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior malignancy within 5 years except: Adequately treated basal cell or squamous cell skin cancer Adequately treated stage I or II cancer In situ cervical cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy or immunotherapy No concurrent immunotherapy Chemotherapy: No prior chemotherapy for metastatic disease At least 4 weeks since prior adjuvant chemotherapy No prior adjuvant cyclophosphamide, methotrexate, or fluorouracil No other concurrent chemotherapy Endocrine therapy: No concurrent hormone therapy Radiotherapy: See Disease Characteristics At least 14 days since prior radiotherapy Surgery: At least 2 weeks since prior surgery

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）

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。

赞助

Southwest Oncology Group

合作者

National Cancer Institute (NCI)

调查人员

学习椅：Raymond A. Kempf, MD、University of Southern California

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

1998年10月1日

初级完成 (实际的)

2001年9月1日

研究完成 (实际的)

2003年1月1日

研究注册日期

首次提交

1999年11月1日

首先提交符合 QC 标准的

2004年6月23日

首次发布 (估计)

2004年6月24日

研究记录更新

最后更新发布 (估计)

2012年10月8日

上次提交的符合 QC 标准的更新

2012年10月5日

最后验证

2012年10月1日

环磷酰胺的临床试验

Tianjin Medical University Cancer Institute and...
CSPC Ouyi Pharmaceutical Co., Ltd.

尚未招聘

CMOEP 治疗未经治疗的外周 T 细胞淋巴瘤

外周T细胞淋巴瘤

中国