Brief Title
Capecitabine in Treating Patients With Malignant Mesothelioma
Official Title
Capecitabine (Xeloda) in Malignant Mesothelioma: A Phase II Study
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.
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.
Study Phase
Phase 2
Study Type
Interventional
Condition
Malignant Mesothelioma
Intervention
capecitabine
Study Arms / Comparison Groups
capecitabine
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
27
Start Date
November 2000
Completion Date
January 2006
Primary Completion Date
December 2003
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Gregory Otterson, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00004183
Organization ID
CALGB-39807
Secondary IDs
U10CA031946
Responsible Party
Sponsor
Study Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Gregory Otterson, MD, Study Chair, Ohio State Comprehensive Cancer Center
Verification Date
July 2016