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Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer

2013年5月24日 更新者：Gynecologic Oncology Group

A Phase I Feasibility Trial of Carboplatin and Topotecan Followed by Carboplatin and Paclitaxel (Sequential Doublets) in Patients With Previously Untreated Epithelial Ovarian Carcinoma and Primary Peritoneal 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 I trial to study the effectiveness of combination chemotherapy in treating patients who have stage III or stage IV ovarian epithelial or primary peritoneal cancer.

研究概览

地位

完全的

条件

干预/治疗

详细说明

OBJECTIVES: I. Determine the feasibility of administering multiple courses of carboplatin and topotecan without excessive dose modification or course delay in patients with previously untreated ovarian epithelial or primary peritoneal carcinoma. II. Describe the response rate and progression-free interval in these patients with this treatment regimen. III. Determine pharmacokinetic and pharmacodynamic parameters related to the sequence of carboplatin and topotecan administration in these patients.

OUTLINE: Patients are assigned to one of three treatment regimens. Regimen I: Patients receive carboplatin IV over 30 minutes on day 1 followed by topotecan IV over 30 minutes on days 1-3. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Regimen II: Patients receive topotecan IV over 30 minutes on days 1-3 followed by carboplatin IV over 30 minutes on day 3. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Regimen III: Patients receive topotecan IV over 30 minutes on days 1-5 followed by carboplatin IV over 30 minutes on day 5. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment continues every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month and then every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 15-80 patients will be accrued for this study within 2 years.

研究类型

介入性

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

  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2N 4N2
        • Tom Baker Cancer Center - Calgary
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35294-3300
        • University of Alabama at Birmingham Comprehensive Cancer Center
    • California
      • Los Angeles、California、美国、90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Gatos、California、美国、95032
        • Community Hospital of Los Gatos
    • Colorado
      • Denver、Colorado、美国、80010
        • University of Colorado Cancer Center
    • District of Columbia
      • Washington、District of Columbia、美国、20307-5000
        • Walter Reed Army Medical Center
    • Florida
      • Saint Petersburg、Florida、美国、33701
        • Tampa Bay Cancer Consortium
      • Tampa、Florida、美国、33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute
    • Illinois
      • Chicago、Illinois、美国、60637-1470
        • University of Chicago Cancer Research Center
      • Chicago、Illinois、美国、60612
        • Rush-Presbyterian-St. Luke's Medical Center
    • Indiana
      • Indianapolis、Indiana、美国、46202-5289
        • Indiana University Cancer Center
    • Kentucky
      • Lexington、Kentucky、美国、40536-0084
        • Albert B. Chandler Medical Center, University of Kentucky
    • Maryland
      • Bethesda、Maryland、美国、20892
        • Radiation Oncology Branch
    • Massachusetts
      • Boston、Massachusetts、美国、02111
        • Tufts University School of Medicine
      • Worcester、Massachusetts、美国、01655
        • University of Massachusetts Memorial Medical Center
    • Michigan
      • Detroit、Michigan、美国、48201-1379
        • Barbara Ann Karmanos Cancer Institute
    • Mississippi
      • Jackson、Mississippi、美国、39216-4505
        • University of Mississippi Medical Center
    • Missouri
      • Columbia、Missouri、美国、65203
        • Ellis Fischel Cancer Center
      • Saint Louis、Missouri、美国、63110
        • Washington University School of Medicine
    • Montana
      • Billings、Montana、美国、59101
        • CCOP - Montana Cancer Consortium
    • New Jersey
      • Camden、New Jersey、美国、08103
        • Cooper Hospital/University Medical Center
    • New York
      • Albany、New York、美国、12208
        • Cancer Center of Albany Medical Center
      • Brooklyn、New York、美国、11203
        • State University of New York Health Science Center at Brooklyn
      • Manhasset、New York、美国、11030
        • North Shore University Hospital
      • New York、New York、美国、10021
        • Memorial Sloan-Kettering Cancer Center
      • Rochester、New York、美国、14642
        • University of Rochester Cancer Center
      • Stony Brook、New York、美国、11790-7775
        • State University of New York Health Sciences Center - Stony Brook
    • North Carolina
      • Chapel Hill、North Carolina、美国、27599-7295
        • Lineberger Comprehensive Cancer Center, UNC
      • Durham、North Carolina、美国、27710
        • Duke Comprehensive Cancer Center
      • Winston-Salem、North Carolina、美国、27157-1082
        • Comprehensive Cancer Center at Wake Forest University
    • Ohio
      • Cincinnati、Ohio、美国、45219
        • Barrett Cancer Center, The University Hospital
      • Cleveland、Ohio、美国、44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland、Ohio、美国、44106-5065
        • Ireland Cancer Center
      • Columbus、Ohio、美国、43210-1240
        • Arthur G. James Cancer Hospital - Ohio State University
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73190
        • University of Oklahoma College of Medicine
    • Pennsylvania
      • Abington、Pennsylvania、美国、19001
        • Abington Memorial Hospital
      • Hershey、Pennsylvania、美国、17033-0850
        • Milton S. Hershey Medical Center
      • Philadelphia、Pennsylvania、美国、19111
        • Fox Chase Cancer Center
      • Philadelphia、Pennsylvania、美国、19104-4283
        • University of Pennsylvania Cancer Center
      • Philadelphia、Pennsylvania、美国、19107-5541
        • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
    • South Carolina
      • Charleston、South Carolina、美国、29425-0721
        • Medical University of South Carolina
    • Tennessee
      • Nashville、Tennessee、美国、37203
        • Brookview Research, Inc.
    • Texas
      • Dallas、Texas、美国、75235-9154
        • Simmons Cancer Center - Dallas
      • Houston、Texas、美国、77030-4009
        • University of Texas - MD Anderson Cancer Center
    • Virginia
      • Charlottesville、Virginia、美国、22908
        • Cancer Center at the University of Virginia
    • Washington
      • Seattle、Washington、美国、98109-1024
        • Fred Hutchinson Cancer Research Center
      • Tacoma、Washington、美国、98405
        • Tacoma General Hospital

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

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

女性

描述

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian epithelial or primary peritoneal carcinoma Prior surgery required within the past 12 weeks Either optimal (no greater than 1 cm residual disease) or suboptimal residual disease following initial surgery No ovarian epithelial tumors of low malignant potential (borderline tumor) The following histologic epithelial cell types are eligible: Serous adenocarcinoma Mucinous adenocarcinoma Clear cell adenocarcinoma Transitional cell carcinoma Adenocarcinoma not otherwise specified Endometrioid adenocarcinoma Undifferentiated carcinoma Mixed epithelial carcinoma Malignant Brenner tumor

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least lower limit of normal Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT and alkaline phosphatase no greater than 2.5 times ULN No acute hepatitis Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No unstable angina No myocardial infarction within past 6 months Abnormal cardiac conduction (e.g., bundle branch block, heart block) allowed if stable for past 6 months Other: No septicemia or severe infection No severe gastrointestinal bleeding No concurrent or prior invasive malignancies within past 5 years except nonmelanoma skin cancer No greater than grade 1 neuropathy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics Other: No prior cancer treatment that contraindicates study protocol

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

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

Gynecologic Oncology Group

合作者

National Cancer Institute (NCI)

调查人员

  • 学习椅：Michael A. Bookman, MD、Fox Chase 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。

一般刊物

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

2000年2月1日

初级完成 (实际的)

2007年1月1日

研究注册日期

首次提交

2000年4月6日

首先提交符合 QC 标准的

2004年2月24日

首次发布 (估计)

2004年2月25日

研究记录更新

最后更新发布 (估计)

2013年5月27日

上次提交的符合 QC 标准的更新

2013年5月24日

最后验证

2008年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CDR0000067547
  • GOG-9906

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.

卡铂的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Singapore

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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