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Capecitabine in Treating Patients With Malignant Mesothelioma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00004183
First received: January 21, 2000
Last updated: September 27, 2013
Last verified: September 2013

January 21, 2000
September 27, 2013
November 2000
December 2003   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00004183 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Capecitabine in Treating Patients With Malignant Mesothelioma
Capecitabine (Xeloda) in Malignant Mesothelioma: A Phase II Study

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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Malignant Mesothelioma
Drug: capecitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
January 2006
December 2003   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004183
CDR0000067422, U10CA031946, CLB-39807
No
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Gregory A. Otterson, MD Ohio State University Comprehensive Cancer Center
Alliance for Clinical Trials in Oncology
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP