Capecitabine in Treating Patients With Malignant Mesothelioma
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| ClinicalTrials.gov Identifier: NCT00004183 |
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Recruitment Status :
Completed
First Posted : February 25, 2004
Last Update Posted : July 14, 2016
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Malignant Mesothelioma | Drug: capecitabine | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 27 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Capecitabine (Xeloda) in Malignant Mesothelioma: A Phase II Study |
| Study Start Date : | November 2000 |
| Actual Primary Completion Date : | December 2003 |
| Actual Study Completion Date : | January 2006 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: capecitabine
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.
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Drug: capecitabine |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004183
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| Study Chair: | Gregory Otterson, MD | Ohio State Comprehensive Cancer Center |
| Responsible Party: | Alliance for Clinical Trials in Oncology |
| ClinicalTrials.gov Identifier: | NCT00004183 |
| Other Study ID Numbers: |
CALGB-39807 U10CA031946 ( U.S. NIH Grant/Contract ) CLB-39807 CDR0000067422 ( Registry Identifier: NCI Physician Data Query ) |
| First Posted: | February 25, 2004 Key Record Dates |
| Last Update Posted: | July 14, 2016 |
| Last Verified: | July 2016 |
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localized malignant mesothelioma advanced malignant mesothelioma recurrent malignant mesothelioma epithelial mesothelioma sarcomatous mesothelioma |
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Mesothelioma Mesothelioma, Malignant Lung Neoplasms Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Pleural Neoplasms Lung Diseases Respiratory Tract Diseases Capecitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |