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History of Changes for Study: NCT00004183
Capecitabine in Treating Patients With Malignant Mesothelioma
Latest version (submitted July 12, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 23, 2005 None (earliest Version on record)
2 January 11, 2007 Contacts/Locations and Study Status
3 February 20, 2007 Sponsor/Collaborators, Eligibility, Contacts/Locations, Conditions, Study Status, References, Arms and Interventions, Study Description and Study Identification
4 August 28, 2007 Study Status
5 October 25, 2007 Study Status
6 November 14, 2007 Study Status
7 December 1, 2007 Contacts/Locations and Study Status
8 December 15, 2007 Contacts/Locations and Study Status
9 May 23, 2008 Arms and Interventions and Study Status
10 July 23, 2008 Study Status
11 February 6, 2010 Study Status
12 April 1, 2011 Recruitment Status, Study Status, Study Identification, Study Design, Oversight and Sponsor/Collaborators
13 September 27, 2013 Sponsor/Collaborators, Study Identification and Study Status
14 July 12, 2016 Contacts/Locations, Arms and Interventions, Study Status, Study Identification and Study Design
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Study NCT00004183
Submitted Date:  June 23, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: CDR0000067422
Brief Title: Capecitabine in Treating Patients With Malignant Mesothelioma
Official Title: Phase II Study of Capecitabine in Patients With Malignant Mesothelioma
Secondary IDs: CLB-39807
Open or close this module Study Status
Record Verification: February 2004
Overall Status: Active, not recruiting
Study Start: November 2000
Primary Completion:
Study Completion:
First Submitted: January 21, 2000
First Submitted that
Met QC Criteria:
February 24, 2004
First Posted: February 25, 2004 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 23, 2005
Last Update Posted: June 24, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Cancer Institute (NCI)
Responsible Party:
Collaborators: Cancer and Leukemia Group B
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have malignant mesothelioma.

Detailed Description:

OBJECTIVES: I. Determine the response rate, overall survival, and failure free survival of patients with malignant mesothelioma treated with capecitabine.

II. Determine the toxicity of this regimen in these patients.

PROTOCOL OUTLINE: This is a multicenter study. Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 1 year, every 3 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL:

A total of 25 patients will be accrued for this study within 7-9 months.

Open or close this module Conditions
Conditions: Recurrent Malignant Mesothelioma
Advanced Malignant Mesothelioma
Localized Malignant Mesothelioma
Sarcomatous Mesothelioma
Epithelial Mesothelioma
Keywords: adult solid tumor
advanced malignant mesothelioma
body system/site cancer
cancer
cellular diagnosis, malignant mesothelioma
epithelial mesothelioma
localized malignant mesothelioma
malignant mesothelioma
pleura cancer
recurrent malignant mesothelioma
sarcomatous mesothelioma
solid tumor
stage, malignant mesothelioma
thorax/respiratory cancer
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model:
Number of Arms:
Masking: (masked roles unspecified)
Enrollment:
Open or close this module Arms and Interventions
Intervention Details:
Drug: capecitabine
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex:
Gender Based:
Accepts Healthy Volunteers:
Criteria:

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Histologically proven malignant mesothelioma not amenable to potentially curative radiotherapy or surgery; Epithelial, sarcomatoid, or mixed subtype; Any site of origin allowed including, but not limited to, the following: Pleura; Peritoneum; Pericardium; Tunica vaginalis
  • Measurable disease; At least one lesion accurately measured in at least one dimension; Lesion at least 20 mm at largest diameter with conventional techniques or at least 10 mm with spiral CT scan
  • The following are not considered measurable disease: Bone lesions; Leptomeningeal disease; Ascites; Pleural/pericardial effusion; Abdominal masses not confirmed and followed by imaging techniques; Cystic lesions; Tumor lesions located in a previously irradiated area

--Prior/Concurrent Therapy--

  • Biologic therapy: Concurrent epoetin alfa allowed
  • Chemotherapy: No prior systemic cytotoxic chemotherapy for malignant mesothelioma; Prior intrapleural cytotoxic or sclerosing agents (including bleomycin) allowed; No other concurrent chemotherapy
  • Endocrine therapy: No concurrent hormonal therapy except the following: Steroids administered for adrenal failure; Hormonal therapy administered for nonmalignant conditions (e.g., insulin for diabetes); Intermittent use of dexamethasone as an antiemetic
  • Radiotherapy: At least 4 weeks since prior radiotherapy; Prior irradiation of symptomatic lesion allowed if there is other measurable disease outside the radiation port; No concurrent radiotherapy
  • Surgery: At least 2 weeks since prior major surgery
  • Other: No concurrent leucovorin calcium or folinic acid

--Patient Characteristics--

  • Age: 18 and over
  • Performance status: ECOG 0 or 1
  • Life expectancy: Not specified
  • Hematopoietic: Granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3
  • Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT no greater than 2.5 times ULN
  • Renal: Creatinine no greater than 1.5 times ULN
  • Other: Not pregnant or nursing; Fertile patients must use effective contraception; No active second malignancy except nonmelanomatous skin; Not considered an active second malignancy if: Therapy has been completed; Less than 30% risk of relapse according to the physician; No malabsorption syndrome
Open or close this module Contacts/Locations
Study Officials: Gregory Otterson
Study Chair
Cancer and Leukemia Group B
Locations: United States, Alabama
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, United States, 35233-1996
United States, California
University of California San Diego Cancer Center
La Jolla, California, United States, 92093-0658
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States, 94121
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94143-0128
United States, Delaware
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States, 19899
United States, District of Columbia
Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Florida
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Illinois
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, United States, 60612
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Iowa
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States, 52722
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, United States, 52242-1009
United States, Maine
Veterans Affairs Medical Center - Togus
Togus, Maine, United States, 04330
United States, Maryland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Minnesota
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55417
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States, 65201
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-3330
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New York
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States, 14215
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
North Shore University Hospital
Manhasset, New York, United States, 11030
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States, 10021
Mount Sinai Medical Center, NY
New York, New York, United States, 10029
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States, 13210
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13217
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States, 27705
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, United States, 27104-4241
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, United States, 27157-1082
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
United States, Tennessee
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, United States, 38103
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, United States, 38104
United States, Vermont
CCOP - Southwestern Vermont Regional Cancer Center
Bennington, Vermont, United States, 05201
Vermont Cancer Center
Burlington, Vermont, United States, 05401-3498
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States, 05009
United States, Virginia
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, United States, 23249
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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