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S0121, Neoadjuvant Carboplatin, Paclitaxel, and Gemcitabine Followed by Cisplatin and Radiation Therapy in Treating Patients With Locally Advanced or Recurrent Carcinoma of the Urothelium

Sponsor
Southwest Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00055835
Collaborator
National Cancer Institute (NCI) (NIH)
7
Enrollment
92
Locations
43
Duration (Months)
0.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy before radiation therapy, and combining chemotherapy with radiation therapy, may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of neoadjuvant gemcitabine, paclitaxel, and carboplatin followed by cisplatin and radiation therapy in treating patients who have locally advanced or recurrent carcinoma (cancer) of the urothelium.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

  • Determine the overall survival of patients with locally advanced or recurrent carcinoma of the urothelium treated with neoadjuvant carboplatin, paclitaxel, and gemcitabine followed by concurrent cisplatin and radiotherapy.

  • Determine the feasibility of administering this regimen to these patients.

  • Determine the progression-free survival of patients treated with this regimen.

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

  • Determine the response rate (confirmed and unconfirmed) of patients treated with the neoadjuvant regimen and those treated with the whole regimen.

  • Determine the proportion of patients who qualify for concurrent cisplatin and radiotherapy after receiving the neoadjuvant regimen.

  • Determine the potential value of suppressor gene expression analysis (p53 and retinoblastoma gene) and HER2 expression as indicators of prognosis and/or response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive neoadjuvant chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 15 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity.

Within 4-8 weeks after the completion of neoadjuvant chemotherapy, patients receive cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for a maximum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo concurrent radiotherapy 5 days a week for 6 weeks.

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

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 4 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Evaluation of Carboplatin, Paclitaxel and Gemcitabine Followed by Concurrent Cisplatin and Radiation Therapy in Patients With Locally Advanced or Recurrent Urothelial Malignancy
Study Start Date :
Nov 1, 2002
Actual Primary Completion Date :
Jun 1, 2006
Actual Study Completion Date :
Jun 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

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

    • Histologically confirmed primary or recurrent invasive carcinoma of the urothelium

    • Transitional, squamous, or mixed cell subtypes allowed

    • Primary disease site must be the urinary bladder or urethra

    • Disease confined to the true pelvis (T2-T4, N0-N3, M0)

    • Must meet at least 1 of the following criteria:

    • Nodal involvement at or below the level of the bifurcation of the iliac vessels

    • Medically or surgically inoperable

    • Patient refused cystectomy

    • Measurable or nonmeasurable disease

    • Evidence of tumor invasion of the muscularis by cystoscopy and biopsy and detailed bladder mapping within the past 56 days

    • No extrapelvic metastases

    • Eligible to receive radiotherapy

    • Planned radiotherapy at a SWOG-approved facility

    PATIENT CHARACTERISTICS:

    Age

    • 18 and over

    Performance status

    • Zubrod 0-2

    Life expectancy

    • Not specified

    Hematopoietic

    • Granulocyte count at least 1,500/mm^3

    • Platelet count at least lower limit of normal

    Hepatic

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

    • SGOT or SGPT no greater than 2.5 times ULN

    Renal

    • Creatinine clearance at least 60 mL/min OR

    • Creatinine no greater than ULN

    Gastrointestinal

    • No chronic diarrhea

    • No malabsorption

    • No extensive diverticular disease of the colon

    • No inflammatory bowel disease

    • No other pre-existing gastrointestinal disorders

    Other

    • Not pregnant or nursing

    • Fertile patients must use effective contraception

    • No active infections requiring antibiotics

    • 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 currently in complete remission

    PRIOR CONCURRENT THERAPY:

    Biologic therapy

    • Not specified

    Chemotherapy

    • No prior chemotherapy for patients with a current diagnosis of advanced bladder cancer that is also the initial diagnosis

    • No prior systemic chemotherapy except adjuvant therapy for recurrent disease completed more than 6 months ago

    • No prior carboplatin

    • No prior paclitaxel

    • No prior gemcitabine

    Endocrine therapy

    • Not specified

    Radiotherapy

    • See Disease Characteristics

    • No prior pelvic radiotherapy

    Surgery

    • See Disease Characteristics

    • Recovered from prior surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MBCCOP - Gulf Coast Mobile Alabama United States 36607
    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 Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    7 Veterans Affairs Medical Center - Little Rock Little Rock Arkansas United States 72205
    8 City of Hope Comprehensive Cancer Center Duarte California United States 91010-3000
    9 USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California United States 90033
    10 Jonsson Comprehensive Cancer Center at UCLA Los Angeles California United States 90095-1781
    11 Veterans Affairs Outpatient Clinic - Martinez Martinez California United States 94553
    12 CCOP - Bay Area Tumor Institute Oakland California United States 94609-3305
    13 Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Orange California United States 92868
    14 University of California Davis Cancer Center Sacramento California United States 95817
    15 CCOP - Santa Rosa Memorial Hospital Santa Rosa California United States 95403
    16 University of Colorado Cancer Center at University of Colorado Health Sciences Center Aurora Colorado United States 80010
    17 Veterans Affairs Medical Center - Denver Denver Colorado United States 80220
    18 MBCCOP - Howard University Cancer Center Washington District of Columbia United States 20060
    19 Veterans Affairs Medical Center - Tampa (Haley) Tampa Florida United States 33612
    20 CCOP - Atlanta Regional Atlanta Georgia United States 30342-1701
    21 MBCCOP - Hawaii Honolulu Hawaii United States 96813
    22 MBCCOP - University of Illinois at Chicago Chicago Illinois United States 60612
    23 Veterans Affairs Medical Center - Chicago Westside Hospital Chicago Illinois United States 60612
    24 CCOP - Central Illinois Decatur Illinois United States 62526
    25 Veterans Affairs Medical Center - Hines Hines Illinois United States 60141
    26 Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood Illinois United States 60153-5500
    27 Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City Kansas United States 66160-7390
    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 40502-2236
    31 Markey Cancer Center at University of Kentucky Chandler Medical Center Lexington Kentucky United States 40536-0084
    32 MBCCOP - LSU Health Sciences Center New Orleans Louisiana United States 70112
    33 Tulane Cancer Center at Tulane University Hospital and Clinic New Orleans Louisiana United States 70112
    34 Veterans Affairs Medical Center - New Orleans New Orleans Louisiana United States 70112
    35 Veterans Affairs Medical Center - Shreveport Shreveport Louisiana United States 71101-4295
    36 Feist-Weiller Cancer Center at Louisiana State University Health Sciences Shreveport Louisiana United States 71130-3932
    37 Cancer Research Center at Boston Medical Center Boston Massachusetts United States 02118
    38 CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan United States 48106
    39 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0946
    40 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379
    41 Veterans Affairs Medical Center - Detroit Detroit Michigan United States 48201-1932
    42 Josephine Ford Cancer Center at Henry Ford Health System Detroit Michigan United States 48202
    43 CCOP - Grand Rapids Grand Rapids Michigan United States 49503
    44 CCOP - Beaumont Royal Oak Michigan United States 48073-6769
    45 Providence Cancer Institute at Providence Hospital - Southfield Campus Southfield Michigan United States 48075
    46 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
    47 Veterans Affairs Medical Center - Jackson Jackson Mississippi United States 39216
    48 CCOP - Kansas City Kansas City Missouri United States 64131
    49 Saint Louis University Cancer Center Saint Louis Missouri United States 63110
    50 CCOP - St. Louis-Cape Girardeau Saint Louis Missouri United States 63141
    51 CCOP - Cancer Research for the Ozarks Springfield Missouri United States 65807
    52 CCOP - Montana Cancer Consortium Billings Montana United States 59101
    53 Veterans Affairs Medical Center - Albuquerque Albuquerque New Mexico United States 87108-5138
    54 MBCCOP - University of New Mexico HSC Albuquerque New Mexico United States 87131
    55 Western New York Urology Associates Buffalo New York United States 14220
    56 NYU Cancer Institute at New York University Medical Center New York New York United States 10016
    57 Herbert Irving Comprehensive Cancer Center at Columbia University New York New York United States 10032
    58 James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester New York United States 14642
    59 CCOP - Southeast Cancer Control Consortium Goldsboro North Carolina United States 27534-9479
    60 Veterans Affairs Medical Center - Cincinnati Cincinnati Ohio United States 45220-2288
    61 Charles M. Barrett Cancer Center at University Hospital Cincinnati Ohio United States 45267-0501
    62 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195-9001
    63 CCOP - Columbus Columbus Ohio United States 43206
    64 Veterans Affairs Medical Center - Dayton Dayton Ohio United States 45428-1002
    65 CCOP - Dayton Dayton Ohio United States 45429
    66 Oklahoma University Medical Center Oklahoma City Oklahoma United States 73104
    67 Cancer Institute at Oregon Health and Science University Portland Oregon United States 97201-3098
    68 CCOP - Columbia River Oncology Program Portland Oregon United States 97225
    69 Veterans Affairs Medical Center - Charleston Charleston South Carolina United States 29401-5799
    70 Hollings Cancer Center at Medical University of South Carolina Charleston South Carolina United States 29425
    71 CCOP - Greenville Greenville South Carolina United States 29615
    72 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
    73 University of Tennessee Cancer Institute at Methodist Central Hospital Memphis Tennessee United States 38104
    74 Harrington Cancer Center Amarillo Texas United States 79106
    75 Texas Tech University Health Sciences Center School of Medicine Amarillo Texas United States 79106
    76 Veterans Affairs Medical Center - Amarillo Amarillo Texas United States 79106
    77 Brooke Army Medical Center Fort Sam Houston Texas United States 78234-6200
    78 University of Texas Medical Branch Galveston Texas United States 77555-0565
    79 M.D. Anderson Cancer Center at University of Texas Houston Texas United States 77030-4095
    80 Baylor College of Medicine Houston Texas United States 77030
    81 UMC Southwest Cancer and Research Center Lubbock Texas United States 79415-3364
    82 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229-3900
    83 Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio Texas United States 78229
    84 Veterans Affairs Medical Center - Temple Temple Texas United States 76504
    85 CCOP - Scott and White Hospital Temple Texas United States 76508
    86 Huntsman Cancer Institute at University of Utah Salt Lake City Utah United States 84112-5550
    87 Veterans Affairs Medical Center - Salt Lake City Salt Lake City Utah United States 84148
    88 Sentara Cancer Institute at Sentara Norfolk General Hospital Norfolk Virginia United States 23510-1115
    89 CCOP - Virginia Mason Research Center Seattle Washington United States 98101
    90 Veterans Affairs Medical Center - Seattle Seattle Washington United States 98108
    91 Puget Sound Oncology Consortium Seattle Washington United States 98109
    92 CCOP - Northwest Tacoma Washington United States 98405-0986

    Sponsors and Collaborators

    • Southwest Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Ulka N. Vaishampayan, MD, Barbara Ann Karmanos Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00055835
    Other Study ID Numbers:
    • CDR0000271309
    • S0121
    • U10CA032102
    First Posted:
    Mar 7, 2003
    Last Update Posted:
    Jan 31, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by Southwest Oncology Group
    recurrent bladder cancer
    stage III bladder cancer
    squamous cell carcinoma of the bladder
    stage II bladder cancer
    recurrent urethral cancer
    urethral cancer associated with invasive bladder cancer
    distal urethral cancer
    proximal urethral cancer
    stage IV bladder cancer
    transitional cell carcinoma of the bladder
    Additional relevant MeSH terms:
    Urinary Bladder Neoplasms
    Urethral Neoplasms
    Gemcitabine
    Paclitaxel
    Carboplatin

    Study Results

    No Results Posted as of Jan 31, 2013