S9926 Temozolomide in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumors

• Sponsor: Southwest Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00005597
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 25
• Locations: 106
• Arm: 1
• Duration (Months): 66
• Patients Per Site: 0.2
• Patients Per Site Per Month: 0

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 temozolomide in treating patients who have unresectable or metastatic gastrointestinal stromal tumors.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Stromal Tumor	Drug: temozolomide	Phase 2

Detailed Description

OBJECTIVES:

• Determine the complete and partial response (confirmed and unconfirmed) in patients with unresectable or metastatic gastrointestinal stromal tumors treated with temozolomide.

• Determine the qualitative or quantitative toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving a confirmed complete response (CR) receive 2 additional courses after a confirmed CR.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 13-27 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of Temozolomide in Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)
• Study Start Date: Apr 1, 2000
• Actual Primary Completion Date: Oct 1, 2005
• Actual Study Completion Date: Oct 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Temozolomide 200 mg/m^2/day, PO, on Days 1-5 of each 28 day cycle.	Drug: temozolomide; 200 mg/m^2/day, PO, on Days 1-5 of each 28 day cycle.; Other Names: NSC-362856

Outcome Measures

Primary Outcome Measures

1. Assess response (confirmed & unconfirmed, complete & partial response) [3 years]

Secondary Outcome Measures

1. Toxicities [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed unresectable or metastatic gastrointestinal stromal tumor (GIST)

• Primary (gastrointestinal or intra-abdominal origin) tumor

• At least 1 measurable lesion by x-ray, CT, MRI, ultrasound, or physical examination

• If lesions within prior radiation port are used as target lesions for response assessment, those lesions must have demonstrated clear progression after completion of radiotherapy

• No uterine or retroperitoneal sarcomas or non-intra-abdominal leiomyosarcomas

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC (white blood count) at least 3,000/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal (ULN)

Renal:

• Creatinine no greater than 1.5 times ULN

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No medical or psychological conditions that would preclude study participation

• No major infection requiring systemic antibiotics

• No uncontrolled bacterial, viral, or fungal infection

• No other prior malignancy within the past 5 years except:

• Adequately treated basal cell or squamous cell skin cancer

• Adequately treated stage I or II cancer in complete remission

• Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 30 days since prior biologic therapy

• Prior imatinib mesylate as adjuvant therapy or for metastatic disease allowed

Chemotherapy:

• No prior chemotherapy for GIST

• At least 30 days since other prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• No prior radiotherapy for GIST

• No concurrent radiotherapy for GIST

• Concurrent palliative radiotherapy for painful metastases (encompassing a total portal of no greater than 5 x 5 cm) allowed

Surgery:

• See Disease Characteristics

• At least 4 weeks since prior major surgery and recovered

Other:

• At least 30 days since prior investigational drugs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MBCCOP - Gulf Coast	Mobile	Alabama	United States	36688
2	CCOP - Western Regional, Arizona	Phoenix	Arizona	United States	85006-2726
3	Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)	Phoenix	Arizona	United States	85012
4	Veterans Affairs Medical Center - Tucson	Tucson	Arizona	United States	85723
5	Arizona Cancer Center at University of Arizona Health Sciences Center	Tucson	Arizona	United States	85724
6	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
7	Veterans Affairs Medical Center - Little Rock (McClellan)	Little Rock	Arkansas	United States	72205
8	City of Hope Comprehensive Cancer Center	Duarte	California	United States	91010
9	Veterans Affairs Medical Center - Long Beach	Long Beach	California	United States	90822
10	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California	United States	90033-0804
11	Veterans Affairs Medical Center - West Los Angeles	Los Angeles	California	United States	90073
12	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California	United States	90095-1781
13	Veterans Affairs Outpatient Clinic - Martinez	Martinez	California	United States	94553
14	CCOP - Bay Area Tumor Institute	Oakland	California	United States	94609-3305
15	Chao Family Comprehensive Cancer Center	Orange	California	United States	92868
16	University of California Davis Cancer Center	Sacramento	California	United States	95817
17	UCSF Comprehensive Cancer Center	San Francisco	California	United States	94143-0128
18	CCOP - Santa Rosa Memorial Hospital	Santa Rosa	California	United States	95403
19	David Grant Medical Center	Travis Air Force Base	California	United States	94535
20	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Denver	Colorado	United States	80010
21	Veterans Affairs Medical Center - Denver	Denver	Colorado	United States	80220
22	MBCCOP - Howard University Cancer Center	Washington	District of Columbia	United States	20060
23	CCOP - Atlanta Regional	Atlanta	Georgia	United States	30342-1701
24	Dwight David Eisenhower Army Medical Center	Fort Gordon	Georgia	United States	30905-5650
25	Cancer Research Center of Hawaii	Honolulu	Hawaii	United States	96813-2424
26	MBCCOP - Hawaii	Honolulu	Hawaii	United States	96813
27	Tripler Army Medical Center	Honolulu	Hawaii	United States	96859-5000
28	MBCCOP - University of Illinois at Chicago	Chicago	Illinois	United States	60612-7323
29	Veterans Affairs Medical Center - Chicago (Westside Hospital)	Chicago	Illinois	United States	60612
30	CCOP - Central Illinois	Decatur	Illinois	United States	62526
31	Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)	Hines	Illinois	United States	60141
32	Loyola University Medical Center	Maywood	Illinois	United States	60153-5500
33	University of Kansas Medical Center	Kansas City	Kansas	United States	66160-7353
34	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
35	Veterans Affairs Medical Center - Wichita	Wichita	Kansas	United States	67218
36	Veterans Affairs Medical Center - Lexington	Lexington	Kentucky	United States	40502-2236
37	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky	United States	40536-0084
38	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
39	Tulane University School of Medicine	New Orleans	Louisiana	United States	70112
40	Veterans Affairs Medical Center - New Orleans	New Orleans	Louisiana	United States	70112
41	Louisiana State University Health Sciences Center - Shreveport	Shreveport	Louisiana	United States	71130-3932
42	Veterans Affairs Medical Center - Shreveport	Shreveport	Louisiana	United States	71130
43	Boston Medical Center	Boston	Massachusetts	United States	02118
44	Veterans Affairs Medical Center - Boston (Jamaica Plain)	Jamaica Plain	Massachusetts	United States	02130
45	Veterans Affairs Medical Center - Ann Arbor	Ann Arbor	Michigan	United States	48105
46	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
47	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0912
48	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201-1379
49	Veterans Affairs Medical Center - Detroit	Detroit	Michigan	United States	48201-1932
50	Henry Ford Hospital	Detroit	Michigan	United States	48202
51	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
52	CCOP - Beaumont	Royal Oak	Michigan	United States	48073-6769
53	Providence Hospital - Southfield	Southfield	Michigan	United States	48075-9975
54	CCOP - Duluth	Duluth	Minnesota	United States	55805
55	Veterans Affairs Medical Center - Biloxi	Biloxi	Mississippi	United States	39531-2410
56	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216-4505
57	Veterans Affairs Medical Center - Jackson	Jackson	Mississippi	United States	39216
58	Veterans Affairs Medical Center - Kansas City	Kansas City	Missouri	United States	64128
59	CCOP - Kansas City	Kansas City	Missouri	United States	64131
60	St. Louis University Health Sciences Center	Saint Louis	Missouri	United States	63110
61	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri	United States	63141
62	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65807
63	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
64	Veterans Affairs Medical Center - Albuquerque	Albuquerque	New Mexico	United States	87108-5138
65	MBCCOP - University of New Mexico HSC	Albuquerque	New Mexico	United States	87131
66	Veterans Affairs Medical Center - Albany	Albany	New York	United States	12208
67	Herbert Irving Comprehensive Cancer Center at Columbia University	New York	New York	United States	10032
68	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York	United States	14642
69	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina	United States	27104-4241
70	Veterans Affairs Medical Center - Cincinnati	Cincinnati	Ohio	United States	45220-2288
71	Barrett Cancer Center	Cincinnati	Ohio	United States	45267-0501
72	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195-9001
73	CCOP - Columbus	Columbus	Ohio	United States	43206
74	Veterans Affairs Medical Center - Dayton	Dayton	Ohio	United States	45428
75	CCOP - Dayton	Dayton	Ohio	United States	45429
76	CCOP - Toledo Community Hospital	Toledo	Ohio	United States	43623-3456
77	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
78	Veterans Affairs Medical Center - Oklahoma City	Oklahoma City	Oklahoma	United States	73104
79	Oregon Cancer Institute	Portland	Oregon	United States	97201-3098
80	Veterans Affairs Medical Center - Portland	Portland	Oregon	United States	97207
81	CCOP - Columbia River Oncology Program	Portland	Oregon	United States	97225
82	Veterans Affairs Medical Center - Charleston	Charleston	South Carolina	United States	29401-5799
83	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina	United States	29425
84	CCOP - Greenville	Greenville	South Carolina	United States	29615
85	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
86	University of Tennessee Cancer Institute	Memphis	Tennessee	United States	38103
87	Danville Radiation Therapy Center	Memphis	Tennessee	United States	38104
88	Harrington Cancer Center	Amarillo	Texas	United States	79106
89	Veterans Affairs Medical Center - Amarillo	Amarillo	Texas	United States	79106
90	Veterans Affairs Medical Center - Dallas	Dallas	Texas	United States	75216
91	Brooke Army Medical Center	Fort Sam Houston	Texas	United States	78234-6200
92	University of Texas Medical Branch	Galveston	Texas	United States	77555-0565
93	Veterans Affairs Medical Center - Houston	Houston	Texas	United States	77030
94	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229-3900
95	Veterans Affairs Medical Center - San Antonio (Murphy)	San Antonio	Texas	United States	78229
96	Veterans Affairs Medical Center - Temple	Temple	Texas	United States	76504
97	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
98	Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112-5550
99	Veterans Affairs Medical Center - Salt Lake City	Salt Lake City	Utah	United States	84148
100	Fletcher Allen Health Care - University Health Center Campus	Burlington	Vermont	United States	05401
101	MBCCOP - Massey Cancer Center	Richmond	Virginia	United States	23298-0037
102	CCOP - Virginia Mason Research Center	Seattle	Washington	United States	98101
103	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington	United States	98104
104	Veterans Affairs Medical Center - Seattle	Seattle	Washington	United States	98108
105	CCOP - Northwest	Tacoma	Washington	United States	98405-0986
106	Madigan Army Medical Center	Tacoma	Washington	United States	98431-5000

Sponsors and Collaborators

• Southwest Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Mark M. Zalupski, MD, University of Michigan Rogel Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Southwest Oncology Group
• ClinicalTrials.gov Identifier: NCT00005597
• Other Study ID Numbers: CDR0000067710; S9926; U10CA032102
• First Posted: Jan 27, 2003
• Last Update Posted: Jan 3, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Southwest Oncology Group: gastrointestinal stromal tumor
• Additional relevant MeSH terms: Gastrointestinal Stromal Tumors; Temozolomide

Study Results

No Results Posted as of Jan 3, 2013