S9915 Triacetyluridine, Fluorouracil, and Leucovorin in Treating Patients With Unresectable, Locally Advanced, or Metastatic Cancer of the Esophagus or Stomach

Sponsor
Southwest Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00004233
Collaborator
National Cancer Institute (NCI) (NIH)
65
97
1
71
0.7
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. 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:
  • 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.

  • 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

Study Type:
Interventional
Actual Enrollment :
65 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of PN-401, 5-FU and Leucovorin in Unresectable or Metastatic Adenocarcinoma of the Stomach
Study Start Date :
Feb 1, 2001
Actual Primary Completion Date :
Jan 1, 2007
Actual Study Completion Date :
Jan 1, 2007

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:
  • 5-FU
  • Drug: leucovorin calcium
    Other Names:
  • LCV; leucovorin
  • Drug: triacetyluridine
    Other Names:
  • PN-401
  • Outcome Measures

    Primary Outcome Measures

    1. Six month survival [six months after registration]

    Secondary Outcome Measures

    1. evaluate quantitative and qualitative toxicities [three years at most]

    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 proven unresectable, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction

    • No known brain metastases

    • 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:
    • Absolute neutrophil count at least 1,500/mm^3

    • Platelet count greater than 100,000/mm^3

    Hepatic:
    • Bilirubin no greater than upper limit of normal (ULN)

    • SGOT or SGPT no greater than 1.5 times ULN (5 times ULN if liver tumor present)

    Renal:
    • Creatinine no greater than ULN
    Other:
    • Not pregnant or nursing

    • Fertile patients must use effective contraception

    • Must be able to swallow oral medication

    • No AIDS syndrome or HIV-associated complex

    • 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

    • No concurrent biologic therapy

    Chemotherapy:
    • No prior chemotherapy for advanced or metastatic gastric cancer

    • 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

    • 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.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00004233
    Other Study ID Numbers:
    • CDR0000067477
    • CA32102
    • S9915
    First Posted:
    Aug 25, 2003
    Last Update Posted:
    Jul 25, 2011
    Last Verified:
    May 1, 2010

    Study Results

    No Results Posted as of Jul 25, 2011