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Capecitabine (Xeloda) in Malignant Mesothelioma: A Phase II Study

Phase 2
18 Years
Not Enrolling
Malignant Mesothelioma

Thank you

Trial Information

Capecitabine (Xeloda) in Malignant Mesothelioma: A Phase II Study

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.

Inclusion 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Principal Investigator

Gregory A. Otterson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

November 2000

Completion Date:

January 2006

Related Keywords:

  • Malignant Mesothelioma
  • localized malignant mesothelioma
  • advanced malignant mesothelioma
  • recurrent malignant mesothelioma
  • epithelial mesothelioma
  • sarcomatous mesothelioma
  • Mesothelioma



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Memorial Sloan-Kettering Cancer Center New York, New York  10021
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
Medical University of South Carolina Charleston, South Carolina  29425-0721
Rhode Island Hospital Providence, Rhode Island  02903
Vermont Cancer Center Burlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
University of California San Diego Cancer Center La Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Barnes-Jewish Hospital Saint Louis, Missouri  63110
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
CCOP - North Shore University Hospital Manhasset, New York  11030
State University of New York - Upstate Medical University Syracuse, New York  13210
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer Center Memphis, Tennessee  38103
MBCCOP - Massey Cancer Center Richmond, Virginia  23298-0037
Mount Sinai Medical Center, NY New York, New York  10029
New York Presbyterian Hospital - Cornell Campus New York, New York  10021
Holden Comprehensive Cancer Center at The University of Iowa Iowa City, Iowa  52242-1009
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Lombardi Cancer Center Washington, District of Columbia  20007
Veterans Affairs Medical Center - Birmingham Birmingham, Alabama  35233
CCOP - Southwestern Vermont Regional Cancer Center Bennington, Vermont  05201
Veterans Affairs Medical Center - White River Junction White River Junction, Vermont  05009
Dana-Farber Cancer Institute Boston, Massachusetts  02115
North Shore University Hospital Manhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago, Illinois  60612
Veterans Affairs Medical Center - San Francisco San Francisco, California  94121
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
Veterans Affairs Medical Center - Memphis Memphis, Tennessee  38104
Veterans Affairs Medical Center - Richmond Richmond, Virginia  23249
University of Illinois at Chicago Health Sciences Center Chicago, Illinois  60612
Veterans Affairs Medical Center - Togus Togus, Maine  04330
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia, Missouri  65201
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Veterans Affairs Medical Center - Buffalo Buffalo, New York  14215
Veterans Affairs Medical Center - Syracuse Syracuse, New York  13210
Veterans Affairs Medical Center - Durham Durham, North Carolina  27705
Hematology Oncology Associates of the Quad Cities Bettendorf, Iowa  52722