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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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