Capecitabine in Treating Patients With Malignant Mesothelioma

• ClinicalTrials.gov Identifier: NCT00004183
• Recruitment Status: Completed
• First Posted: February 25, 2004
• Last Update Posted: July 14, 2016
• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Alliance for Clinical Trials in Oncology

Tracking Information

• First Submitted Date: January 21, 2000
• First Posted Date: February 25, 2004
• Last Update Posted Date: July 14, 2016
• Study Start Date: November 2000
• Actual Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Malignant Mesothelioma
• Intervention: Drug: capecitabine

Study Arms

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.

Intervention: Drug: capecitabine

Publications *

• Otterson GA, Herndon JE 2nd, Watson D, Green MR, Kindler HL; Cancer and Leukemia Group B. Capecitabine in malignant mesothelioma: a phase II trial by the Cancer and Leukemia Group B (39807). Lung Cancer. 2004 May;44(2):251-9. doi: 10.1016/j.lungcan.2003.10.011.
• Otterson GA, Herndon J, Watson D, et al.: Capecitabine in malignant mesothelioma: a phase II trial by the Cancer and Leukemia Group B (CALGB 39807). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2778, 691, 2003.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 1, 2011): 27
• Original Enrollment: Not Provided
• Actual Study Completion Date: January 2006
• Actual Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00004183
• Other Study ID Numbers: CALGB-39807; U10CA031946 ( U.S. NIH Grant/Contract ); CLB-39807; CDR0000067422 ( Registry Identifier: NCI Physician Data Query )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Alliance for Clinical Trials in Oncology
• Original Responsible Party: Not Provided
• Current Study Sponsor: Alliance for Clinical Trials in Oncology
• Original Study Sponsor: National Cancer Institute (NCI)
• Collaborators: National Cancer Institute (NCI)

Investigators

• Study Chair: Gregory Otterson, MD; Ohio State Comprehensive Cancer Center

• PRS Account: Alliance for Clinical Trials in Oncology
• Verification Date: July 2016