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Capecitabine in Treating Patients With Malignant Mesothelioma
This study is ongoing, but not recruiting participants.
First Received: January 21, 2000   Last Updated: July 23, 2008   History of Changes
Sponsor: Cancer and Leukemia Group B
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004183
  Purpose

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.


Condition Intervention Phase
Malignant Mesothelioma
Drug: capecitabine
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Capecitabine (Xeloda) in Malignant Mesothelioma: A Phase II Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2000
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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 cancer Not considered an active second malignancy if: Therapy has been completed Less than 30% risk of relapse according to the physician No malabsorption syndrome

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004183

  Hide Study Locations
Locations
United States, Alabama
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, United States, 35233-1996
United States, California
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94143-0128
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
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 Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
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
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
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, Missouri
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States, 65201
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
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13217
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Mount Sinai Medical Center, NY
New York, New York, United States, 10029
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
North Shore University Hospital
Manhasset, New York, United States, 11030
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States, 10021
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States, 14215
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States, 13210
United States, North Carolina
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
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States, 27705
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
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Gregory A. Otterson, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
  More Information

Additional Information:
Publications:
Otterson GA, Herndon JE 2nd, Watson D, Green MR, Kindler HL; Cancer and Leukemia Group B. Capecitabine in malignant mesothelioma: a phase II trial by the Cancer and Leukemia Group B (39807). Lung Cancer. 2004 May;44(2):251-9.
Otterson GA, Herndon J, Watson D, et al.: Capecitabine in malignant mesothelioma: a phase II trial by the Cancer and Leukemia Group B (CALGB 39807). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2778, 691, 2003.

Study ID Numbers: CDR0000067422, CLB-39807
Study First Received: January 21, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00004183     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
localized malignant mesothelioma
advanced malignant mesothelioma
recurrent malignant mesothelioma
epithelial mesothelioma
sarcomatous mesothelioma

Additional relevant MeSH terms:
Antimetabolites
Capecitabine
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Neoplasms, Mesothelial
Antineoplastic Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009