S9915 Triacetyluridine, Fluorouracil, and Leucovorin in Treating Patients With Unresectable, Locally Advanced, or Metastatic Cancer of the Esophagus or Stomach
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. Chemoprotective drugs such as triacetyluridine may protect normal cells from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of triacetyluridine, fluorouracil, and leucovorin in treating patients who have unresectable, locally advanced, or metastatic cancer of the esophagus or stomach.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
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Assess the 6-month survival rate in patients with unresectable, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with triacetyluridine, fluorouracil, and leucovorin calcium.
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Evaluate the qualitative and quantitative toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 30 minutes beginning 1 hour into leucovorin calcium infusion on days 1, 8, 15, 22, 29, and 36. Patients receive oral triacetyluridine every 8 hours on days 1-3, 8-10, 15-17, 22-24, 29-31, and 36-38 beginning 8 hours after completion of each fluorouracil infusion. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 5-FU, Leucovorin and PN-401 PN401 is given on Days 1-3 weekly for six weeks; 5FU and leucovorin are given on Day 1 weekely for six weeks; followed by two weeks of rest. Continued in 8 week cycles until one of the criteria for removal from treatment is met. |
Drug: fluorouracil
Other Names:
Drug: leucovorin calcium
Other Names:
Drug: triacetyluridine
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Six month survival [six months after registration]
Secondary Outcome Measures
- evaluate quantitative and qualitative toxicities [three years at most]
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Histologically or cytologically proven unresectable, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction
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No known brain metastases
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Negative brain imaging required for neurologic signs and symptoms
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Zubrod 0-1
Life expectancy:
- Not specified
Hematopoietic:
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Absolute neutrophil count at least 1,500/mm^3
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Platelet count greater than 100,000/mm^3
Hepatic:
-
Bilirubin no greater than upper limit of normal (ULN)
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SGOT or SGPT no greater than 1.5 times ULN (5 times ULN if liver tumor present)
Renal:
- Creatinine no greater than ULN
Other:
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Not pregnant or nursing
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Fertile patients must use effective contraception
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Must be able to swallow oral medication
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No AIDS syndrome or HIV-associated complex
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No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy:
-
No prior biologic therapy
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No concurrent biologic therapy
Chemotherapy:
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No prior chemotherapy for advanced or metastatic gastric cancer
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At least 6 months since prior chemotherapy as adjuvant or radiation sensitizer
Endocrine therapy:
- Not specified
Radiotherapy:
-
At least 1 month since prior radiotherapy and recovered
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No concurrent radiotherapy
Surgery:
- At least 3 weeks since prior major surgical resection of intra-abdominal organs and recovered
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | MBCCOP - Gulf Coast | Mobile | Alabama | United States | 36688 |
2 | CCOP - Greater Phoenix | Phoenix | Arizona | United States | 85006-2726 |
3 | Veterans Affairs Medical Center - Phoenix (Hayden) | Phoenix | Arizona | United States | 85012 |
4 | Veterans Affairs Medical Center - Tucson | Tucson | Arizona | United States | 85723 |
5 | Arizona Cancer 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 | Cancer Center and Beckman Research Institute, City of Hope | Duarte | California | United States | 91010-3000 |
9 | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | United States | 90033-0804 |
10 | Veterans Affairs Medical Center - West Los Angeles | Los Angeles | California | United States | 90073 |
11 | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | United States | 90095-1781 |
12 | Veterans Affairs Outpatient Clinic - Martinez | Martinez | California | United States | 94553 |
13 | CCOP - Bay Area Tumor Institute | Oakland | California | United States | 94609-3305 |
14 | Chao Family Comprehensive Cancer Center | Orange | California | United States | 92868 |
15 | University of California Davis Medical Center | Sacramento | California | United States | 95817 |
16 | UCSF Cancer Center and Cancer Research Institute | San Francisco | California | United States | 94143-0128 |
17 | CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California | United States | 95403 |
18 | David Grant Medical Center | Travis Air Force Base | California | United States | 94535 |
19 | University of Colorado Cancer Center | Denver | Colorado | United States | 80010 |
20 | Veterans Affairs Medical Center - Denver | Denver | Colorado | United States | 80220 |
21 | CCOP - Atlanta Regional | Atlanta | Georgia | United States | 30342-1701 |
22 | Dwight David Eisenhower Army Medical Center | Fort Gordon | Georgia | United States | 30905-5650 |
23 | Cancer Research Center of Hawaii | Honolulu | Hawaii | United States | 96813 |
24 | MBCCOP - University of Illinois at Chicago | Chicago | Illinois | United States | 60612-7323 |
25 | Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago | Illinois | United States | 60612 |
26 | CCOP - Central Illinois | Decatur | Illinois | United States | 62526 |
27 | Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines | Illinois | United States | 60141 |
28 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
29 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160-7357 |
30 | CCOP - Wichita | Wichita | Kansas | United States | 67214-3882 |
31 | Veterans Affairs Medical Center - Wichita | Wichita | Kansas | United States | 67218 |
32 | Veterans Affairs Medical Center - Lexington | Lexington | Kentucky | United States | 40511-1093 |
33 | Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky | United States | 40536-0084 |
34 | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana | United States | 70112 |
35 | Tulane University School of Medicine | New Orleans | Louisiana | United States | 70112 |
36 | Veterans Affairs Medical Center - New Orleans | New Orleans | Louisiana | United States | 70112 |
37 | Louisiana State University Health Sciences Center - Shreveport | Shreveport | Louisiana | United States | 71130-3932 |
38 | Veterans Affairs Medical Center - Shreveport | Shreveport | Louisiana | United States | 71130 |
39 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
40 | Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain | Massachusetts | United States | 02130 |
41 | Veterans Affairs Medical Center - Ann Arbor | Ann Arbor | Michigan | United States | 48105 |
42 | CCOP - Ann Arbor Regional | Ann Arbor | Michigan | United States | 48106 |
43 | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | United States | 48109-0752 |
44 | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | United States | 48201-1379 |
45 | Veterans Affairs Medical Center - Detroit | Detroit | Michigan | United States | 48201-1932 |
46 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
47 | CCOP - Grand Rapids Clinical Oncology Program | Grand Rapids | Michigan | United States | 49503 |
48 | Providence Hospital - Southfield | Southfield | Michigan | United States | 48075-9975 |
49 | CCOP - Duluth | Duluth | Minnesota | United States | 55805 |
50 | Veterans Affairs Medical Center - Biloxi | Biloxi | Mississippi | United States | 39531-2410 |
51 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216-4505 |
52 | Veterans Affairs Medical Center - Jackson | Jackson | Mississippi | United States | 39216 |
53 | Keesler Medical Center - Keesler AFB | Keesler AFB | Mississippi | United States | 39534-2576 |
54 | Veterans Affairs Medical Center - Kansas City | Kansas City | Missouri | United States | 64128 |
55 | CCOP - Kansas City | Kansas City | Missouri | United States | 64131 |
56 | St. Louis University Health Sciences Center | Saint Louis | Missouri | United States | 63110-0250 |
57 | CCOP - St. Louis-Cape Girardeau | Saint Louis | Missouri | United States | 63141 |
58 | CCOP - Cancer Research for the Ozarks | Springfield | Missouri | United States | 65807 |
59 | CCOP - Montana Cancer Consortium | Billings | Montana | United States | 59101 |
60 | Veterans Affairs Medical Center - Albuquerque | Albuquerque | New Mexico | United States | 87108-5138 |
61 | MBCCOP - University of New Mexico HSC | Albuquerque | New Mexico | United States | 87131 |
62 | Veterans Affairs Medical Center - Albany | Albany | New York | United States | 12208 |
63 | St. Vincents Comprehensive Cancer Center | New York | New York | United States | 10011 |
64 | Herbert Irving Comprehensive Cancer Center | New York | New York | United States | 10032 |
65 | University of Rochester Medical Center | Rochester | New York | United States | 14642 |
66 | CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina | United States | 27104-4241 |
67 | Veterans Affairs Medical Center - Cincinnati | Cincinnati | Ohio | United States | 45220-2288 |
68 | Barrett Cancer Center, The University Hospital | Cincinnati | Ohio | United States | 45267-0502 |
69 | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | United States | 44195 |
70 | CCOP - Columbus | Columbus | Ohio | United States | 43206 |
71 | Veterans Affairs Medical Center - Dayton | Dayton | Ohio | United States | 45428 |
72 | CCOP - Dayton | Kettering | Ohio | United States | 45429 |
73 | CCOP - Toledo Community Hospital Oncology Program | Toledo | Ohio | United States | 43623-3456 |
74 | Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | United States | 73104 |
75 | Veterans Affairs Medical Center - Oklahoma City | Oklahoma City | Oklahoma | United States | 73104 |
76 | Oregon Cancer Center | Portland | Oregon | United States | 97201-3098 |
77 | Veterans Affairs Medical Center - Portland | Portland | Oregon | United States | 97207 |
78 | CCOP - Columbia River Program | Portland | Oregon | United States | 97213 |
79 | Veterans Affairs Medical Center - Charleston | Charleston | South Carolina | United States | 29401-5799 |
80 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425-0721 |
81 | CCOP - Greenville | Greenville | South Carolina | United States | 29615 |
82 | CCOP - Upstate Carolina | Spartanburg | South Carolina | United States | 29303 |
83 | Brooke Army Medical Center | Fort Sam Houston | Texas | United States | 78234 |
84 | University of Texas Medical Branch | Galveston | Texas | United States | 77555-0209 |
85 | University of Texas - MD Anderson Cancer Center | Houston | Texas | United States | 77030-4009 |
86 | Veterans Affairs Medical Center - Houston | Houston | Texas | United States | 77030 |
87 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78284-7811 |
88 | Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio | Texas | United States | 78284 |
89 | Veterans Affairs Medical Center - Temple | Temple | Texas | United States | 76504 |
90 | CCOP - Scott and White Hospital | Temple | Texas | United States | 76508 |
91 | Huntsman Cancer Institute | Salt Lake City | Utah | United States | 84112 |
92 | Veterans Affairs Medical Center - Salt Lake City | Salt Lake City | Utah | United States | 84148 |
93 | CCOP - Virginia Mason Research Center | Seattle | Washington | United States | 98101 |
94 | Swedish Cancer Institute | Seattle | Washington | United States | 98104 |
95 | Veterans Affairs Medical Center - Seattle | Seattle | Washington | United States | 98108 |
96 | CCOP - Northwest | Tacoma | Washington | United States | 98405-0986 |
97 | Madigan Army Medical Center | Tacoma | Washington | United States | 98431-5000 |
Sponsors and Collaborators
- Southwest Oncology Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: James H. Doroshow, MD, City of Hope Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000067477
- CA32102
- S9915