Capecitabine in Treating Patients With Malignant Mesothelioma

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00004183

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

Duration (Months)

0.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Mesothelioma	Drug: capecitabine	Phase 2

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 Design

Study Type:

Interventional

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 :

Nov 1, 2000

Actual Primary Completion Date :

Dec 1, 2003

Actual Study Completion Date :

Jan 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: capecitabine

Arm

Intervention/Treatment

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.

Drug: capecitabine

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Veterans Affairs Medical Center - Birmingham	Birmingham	Alabama	United States	35233-1996
2	University of California San Diego Cancer Center	La Jolla	California	United States	92093-0658
3	Veterans Affairs Medical Center - San Francisco	San Francisco	California	United States	94121
4	UCSF Cancer Center and Cancer Research Institute	San Francisco	California	United States	94143-0128
5	CCOP - Christiana Care Health Services	Wilmington	Delaware	United States	19899
6	Lombardi Cancer Center	Washington	District of Columbia	United States	20007
7	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5000
8	CCOP - Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
9	University of Illinois at Chicago Health Sciences Center	Chicago	Illinois	United States	60612
10	Veterans Affairs Medical Center - Chicago (Westside Hospital)	Chicago	Illinois	United States	60612
11	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
12	Hematology Oncology Associates of the Quad Cities	Bettendorf	Iowa	United States	52722
13	Holden Comprehensive Cancer Center at The University of Iowa	Iowa City	Iowa	United States	52242-1009
14	Veterans Affairs Medical Center - Togus	Togus	Maine	United States	04330
15	Marlene & Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland	United States	21201
16	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
17	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts	United States	01655
18	Veterans Affairs Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55417
19	University of Minnesota Cancer Center	Minneapolis	Minnesota	United States	55455
20	Veterans Affairs Medical Center - Columbia (Truman Memorial)	Columbia	Missouri	United States	65201
21	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri	United States	65203
22	Barnes-Jewish Hospital	Saint Louis	Missouri	United States	63110
23	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-3330
24	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
25	Norris Cotton Cancer Center	Lebanon	New Hampshire	United States	03756-0002
26	Veterans Affairs Medical Center - Buffalo	Buffalo	New York	United States	14215
27	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
28	CCOP - North Shore University Hospital	Manhasset	New York	United States	11030
29	North Shore University Hospital	Manhasset	New York	United States	11030
30	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
31	New York Presbyterian Hospital - Cornell Campus	New York	New York	United States	10021
32	Mount Sinai Medical Center, NY	New York	New York	United States	10029
33	State University of New York - Upstate Medical University	Syracuse	New York	United States	13210
34	Veterans Affairs Medical Center - Syracuse	Syracuse	New York	United States	13210
35	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York	United States	13217
36	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina	United States	27599-7295
37	Veterans Affairs Medical Center - Durham	Durham	North Carolina	United States	27705
38	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
39	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina	United States	27104-4241
40	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1082
41	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio	United States	43210-1240
42	Rhode Island Hospital	Providence	Rhode Island	United States	02903
43	Medical University of South Carolina	Charleston	South Carolina	United States	29425-0721
44	University of Tennessee, Memphis Cancer Center	Memphis	Tennessee	United States	38103
45	Veterans Affairs Medical Center - Memphis	Memphis	Tennessee	United States	38104
46	CCOP - Southwestern Vermont Regional Cancer Center	Bennington	Vermont	United States	05201
47	Vermont Cancer Center	Burlington	Vermont	United States	05401-3498
48	Veterans Affairs Medical Center - White River Junction	White River Junction	Vermont	United States	05009
49	Veterans Affairs Medical Center - Richmond	Richmond	Virginia	United States	23249
50	MBCCOP - Massey Cancer Center	Richmond	Virginia	United States	23298-0037