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SWOG-S9635 Fluorouracil Plus Ethynyluracil in Advanced Colorectal Cancer Not Responded to Fluorouracil

Sponsor
Southwest Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00003254
Collaborator
National Cancer Institute (NCI) (NIH)
75
Enrollment
86
Locations
1
Arm
66
Duration (Months)
0.9
Patients Per Site
0
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. Ethynyluracil may help fluorouracil kill more cancer cells by making tumor cells more sensitive to the drug.

PURPOSE: Phase II trial to study the effectiveness of fluorouracil plus ethynyluracil in treating patients with advanced colorectal cancer that has not responded to fluorouracil.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES: I. Assess the confirmed response rate to fluorouracil (5-FU) plus ethynyluracil (776C85) in patients with metastatic colorectal cancer that has been demonstrated to be resistant to 5-FU. II. Assess time to progression and survival in this group of patients.

  1. Assess the frequency and severity of toxicities associated with this treatment.

OUTLINE: Patients are stratified according to relapse while receiving adjuvant therapy (relapse within 12 months of completing adjuvant therapy vs relapse while receiving adjuvant therapy). Patients receive oral doses of ethynyluracil (776C85) and fluorouracil twice daily for 28 days followed by 1 week of rest. Treatment continues every 5 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months the first year, every 4 months the second year, and every 6 months thereafter.

PROJECTED ACCRUAL: A total of 35-75 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial of 5-Fluorouracil Plus 776C85 in Patients With Advanced Resistant Colorectal Cancer
Study Start Date :
Apr 1, 1998
Actual Primary Completion Date :
Nov 1, 2002
Actual Study Completion Date :
Oct 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Experimental: 776C85 + 5-FU

776C85, 10mg/m2/dose, PO, Days 1-28 (BID), q 5 wk; 5-FU, 1.0mg/m2/dose, PO, Days 1-28 (BID), q 5 wk.

Drug: ethynyluracil
10mg/m2/dose, PO, Days 1-28, q 5wk
Other Names:
  • 776C85

    • Drug: fluorouracil
    1.0mg/m2/dose, PO, Days 1-28 BID, q 5wk
    Other Names:
  • 5-FU

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Confirmed Response Rate [Once every 10 weeks until off treatment]

      To assess the confirmed response rate to 5-fluorouracil plus 776C85 in patients with measurable, disseminated colorectal cancer that has been demonstrated to be resistant to 5-fluorouracil.

    Secondary Outcome Measures

    1. Progression and Survival [Once every 10 weeks until progression]

      To assess time to progression and survival in this group of patients.

    2. Toxicities [Once each week during treatment]

      To assess the frequency and severity of toxicities associated with this treatment.

    Eligibility Criteria

    Criteria

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

    • Histologically or cytologically proven metastatic colorectal cancer

    • Prior surgery required

    • No prior treatment for metastatic disease

    • Disease progression while on fluorouracil adjuvant therapy

    • Bidimensionally measurable disease

    • Age: Over 18

    • Performance status: SWOG 0-2

    • Hematopoietic: Platelet count at least 100,000/mm3, Absolute granulocyte count at least 1,500/mm3

    • Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 3 times ULN (no greater than 5 times ULN if liver involvement)

    • Renal: Creatinine clearance at least 50 mL/min

    • Other: Must be able to swallow and retain oral medications No nutritional support by gastrostomy feeding tube or parenteral support No intractable vomiting or nausea

    • Patients with history of prior malignancy must be currently disease free and off all therapy for that malignancy

    • Not pregnant or nursing Fertile patients must use effective contraception

    • Biologic therapy: No concurrent immunotherapy Chemotherapy; At least 3 weeks since prior chemotherapy and recovered; No concurrent flucytosine; No other concurrent chemotherapy

    • Endocrine therapy: No concurrent hormonal therapy

    • Radiotherapy: Prior adjuvant pelvic radiation or radiation to one area of recurrence allowed At least 4 weeks since prior radiotherapy and recovered Total area of bone marrow irradiation must not exceed 25% No concurrent radiotherapy

    • Surgery: At least 2 weeks since prior surgery for colorectal cancer and recovered No prior resection of the stomach or small intestine

    • Other: No other concurrent anticancer therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MBCCOP - University of South Alabama 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 Veterans Affairs Medical Center - Long Beach Long Beach California United States 90822
    9 USC/Norris Comprehensive Cancer Center Los Angeles California United States 90033-0800
    10 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
    11 Beckman Research Institute, City of Hope Los Angeles California United States 91010
    12 CCOP - Bay Area Tumor Institute Oakland California United States 94609-3305
    13 Chao Family Comprehensive Cancer Center Orange California United States 92868
    14 University of California Davis Medical Center Sacramento California United States 95817
    15 UCSF Cancer Center and Cancer Research Institute San Francisco California United States 94115-0128
    16 CCOP - Santa Rosa Memorial Hospital Santa Rosa California United States 95403
    17 David Grant Medical Center Travis Air Force Base California United States 94535
    18 Veterans Affairs Medical Center - Denver Denver Colorado United States 80220
    19 University of Colorado Cancer Center Denver Colorado United States 80262
    20 CCOP - Atlanta Regional Atlanta Georgia United States 30342-1701
    21 Dwight David Eisenhower Army Medical Center Fort Gordon Georgia United States 30905-5650
    22 Cancer Research Center of Hawaii Honolulu Hawaii United States 96813
    23 Tripler Army Medical Center Honolulu Hawaii United States 96859-5000
    24 CCOP - Central Illinois Decatur Illinois United States 62526
    25 Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines Illinois United States 60141
    26 Loyola University Medical Center Maywood Illinois United States 60153
    27 University of Kansas Medical Center Kansas City Kansas United States 66160-7357
    28 CCOP - Wichita Wichita Kansas United States 67214-3882
    29 Veterans Affairs Medical Center - Wichita Wichita Kansas United States 67218
    30 Veterans Affairs Medical Center - Lexington Lexington Kentucky United States 40511-1093
    31 Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky United States 40536-0084
    32 MBCCOP - LSU Medical Center New Orleans Louisiana United States 70112
    33 Tulane University School of Medicine New Orleans Louisiana United States 70112
    34 Veterans Affairs Medical Center - New Orleans New Orleans Louisiana United States 70112
    35 Louisiana State University Health Sciences Center - Shreveport Shreveport Louisiana United States 71130-3932
    36 Veterans Affairs Medical Center - Shreveport Shreveport Louisiana United States 71130
    37 Boston Medical Center Boston Massachusetts United States 02118
    38 Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain Massachusetts United States 02130
    39 Veterans Affairs Medical Center - Ann Arbor Ann Arbor Michigan United States 48105
    40 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0752
    41 Veterans Affairs Medical Center - Detroit Detroit Michigan United States 48201-1932
    42 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201
    43 Henry Ford Hospital Detroit Michigan United States 48202
    44 CCOP - Grand Rapids Clinical Oncology Program Grand Rapids Michigan United States 49503
    45 Providence Hospital - Southfield Southfield Michigan United States 48075-9975
    46 Veterans Affairs Medical Center - Biloxi Biloxi Mississippi United States 39531-2410
    47 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
    48 Veterans Affairs Medical Center - Jackson Jackson Mississippi United States 39216
    49 Keesler Medical Center - Keesler AFB Keesler AFB Mississippi United States 39534-2576
    50 Veterans Affairs Medical Center - Kansas City Kansas City Missouri United States 64128
    51 CCOP - Kansas City Kansas City Missouri United States 64131
    52 St. Louis University Health Sciences Center Saint Louis Missouri United States 63110-0250
    53 CCOP - St. Louis-Cape Girardeau Saint Louis Missouri United States 63141
    54 CCOP - Cancer Research for the Ozarks Springfield Missouri United States 65807
    55 CCOP - Montana Cancer Consortium Billings Montana United States 59101
    56 Veterans Affairs Medical Center - Albuquerque Albuquerque New Mexico United States 87108-5138
    57 MBCCOP - University of New Mexico HSC Albuquerque New Mexico United States 87131
    58 Veterans Affairs Medical Center - Brooklyn Brooklyn New York United States 11209
    59 Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    60 Barrett Cancer Center, The University Hospital Cincinnati Ohio United States 45219
    61 Veterans Affairs Medical Center - Cincinnati Cincinnati Ohio United States 45220-2288
    62 Cleveland Clinic Cancer Center Cleveland Ohio United States 44195
    63 CCOP - Columbus Columbus Ohio United States 43206
    64 Veterans Affairs Medical Center - Dayton Dayton Ohio United States 45428
    65 CCOP - Dayton Kettering Ohio United States 45429
    66 Oklahoma Medical Research Foundation Oklahoma City Oklahoma United States 73104
    67 Veterans Affairs Medical Center - Oklahoma City Oklahoma City Oklahoma United States 73104
    68 Oregon Cancer Center at Oregon Health Sciences University Portland Oregon United States 97201-3098
    69 Veterans Affairs Medical Center - Portland Portland Oregon United States 97207
    70 CCOP - Columbia River Program Portland Oregon United States 97213
    71 CCOP - Greenville Greenville South Carolina United States 29615
    72 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
    73 Simmons Cancer Center - Dallas Dallas Texas United States 75235-9154
    74 Brooke Army Medical Center Fort Sam Houston Texas United States 78234
    75 University of Texas Medical Branch Galveston Texas United States 77555-1329
    76 Texas Tech University Health Science Center Lubbock Texas United States 79423
    77 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78284-7811
    78 Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio Texas United States 78284
    79 Veterans Affairs Medical Center - Temple Temple Texas United States 76504
    80 CCOP - Scott and White Hospital Temple Texas United States 76508
    81 Huntsman Cancer Institute Salt Lake City Utah United States 84132
    82 Veterans Affairs Medical Center - Salt Lake City Salt Lake City Utah United States 84148
    83 CCOP - Virginia Mason Research Center Seattle Washington United States 98101
    84 Swedish Cancer Institute Seattle Washington United States 98104
    85 Veterans Affairs Medical Center - Seattle Seattle Washington United States 98108
    86 CCOP - Northwest Tacoma Washington United States 98405-0986

    Sponsors and Collaborators

    • Southwest Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Cynthia G. Leichman, MD, Albany Medical College

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00003254
    Other Study ID Numbers:
    • CDR0000066138
    • S9635
    • U10CA032102
    First Posted:
    Jun 16, 2004
    Last Update Posted:
    Mar 8, 2012
    Last Verified:
    Mar 1, 2012
    Keywords provided by Southwest Oncology Group
    stage IV colon cancer
    stage IV rectal cancer
    recurrent colon cancer
    recurrent rectal cancer
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Fluorouracil
    Eniluracil

    Study Results

    No Results Posted as of Mar 8, 2012