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Phase II Evaluation of Carboplatin, Paclitaxel and Gemcitabine Followed by Concurrent Cisplatin and Radiation Therapy in Patients With Locally Advanced or Recurrent Urothelial Malignancy


Phase 2
18 Years
N/A
Not Enrolling
Both
Bladder Cancer, Urethral Cancer

Thank you

Trial Information

Phase II Evaluation of Carboplatin, Paclitaxel and Gemcitabine Followed by Concurrent Cisplatin and Radiation Therapy in Patients With Locally Advanced or Recurrent Urothelial Malignancy


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Ulka N. Vaishampayan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000271309

NCT ID:

NCT00055835

Start Date:

November 2002

Completion Date:

June 2006

Related Keywords:

  • Bladder Cancer
  • Urethral Cancer
  • 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
  • Urinary Bladder Neoplasms
  • Urethral Neoplasms

Name

Location

Baylor College of MedicineHouston, Texas  77030
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
MBCCOP - HawaiiHonolulu, Hawaii  96813
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - GreenvilleGreenville, South Carolina  29615
Harrington Cancer CenterAmarillo, Texas  79106
University of Texas Medical BranchGalveston, Texas  77555-1329
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - Grand RapidsGrand Rapids, Michigan  49503
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Scott and White HospitalTemple, Texas  76508
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - Gulf CoastMobile, Alabama  36688
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Veterans Affairs Medical Center - CharlestonCharleston, South Carolina  29401-5799
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
CCOP - NorthwestTacoma, Washington  98405-0986
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
Puget Sound Oncology ConsortiumSeattle, Washington  98109
University of California Davis Cancer CenterSacramento, California  95817
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Veterans Affairs Medical Center - AmarilloAmarillo, Texas  79106
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
Texas Tech University Health Sciences Center School of MedicineAmarillo, Texas  79106
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Tampa (Haley)Tampa, Florida  33612
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Tulane Cancer Center at Tulane University Hospital and ClinicNew Orleans, Louisiana  70112
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
MBCCOP - Howard University Cancer CenterWashington, District of Columbia  20060
Veterans Affairs Medical Center - Little RockLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - HinesHines, Illinois  60141
Josephine Ford Cancer Center at Henry Ford Health SystemDetroit, Michigan  48202
University of Tennessee Cancer Institute at Methodist Central HospitalMemphis, Tennessee  38104
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Western New York Urology AssociatesBuffalo, New York  14220
Veterans Affairs Medical Center - Chicago Westside HospitalChicago, Illinois  60612
Feist-Weiller Cancer Center at Louisiana State University Health SciencesShreveport, Louisiana  71130-3932
Providence Cancer Institute at Providence Hospital - Southfield CampusSouthfield, Michigan  48075
UMC Southwest Cancer and Research CenterLubbock, Texas  79415-3364
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
Sentara Cancer Institute at Sentara Norfolk General HospitalNorfolk, Virginia  23507