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A Sequential Approach to the Treatment of Muscle Invasive, Non-Metastatic Urothelial Carcinoma of the Bladder: A Phase II Trial of Neoadjuvant Gemcitabine, Paclitaxel and Carboplatin With Molecular Correlates


Phase 2
18 Years
N/A
Not Enrolling
Both
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer

Thank you

Trial Information

A Sequential Approach to the Treatment of Muscle Invasive, Non-Metastatic Urothelial Carcinoma of the Bladder: A Phase II Trial of Neoadjuvant Gemcitabine, Paclitaxel and Carboplatin With Molecular Correlates


OBJECTIVES:

- Determine the pathologic complete response of patients with stage II or III
transitional cell cancer of the urothelium treated with neoadjuvant gemcitabine,
paclitaxel, and carboplatin followed by observation or immediate cystectomy.

- Determine, preliminarily, if molecular markers predict response, survival, and tumor
recurrence in patients treated with these regimens.

- Determine recurrence rates and cystectomy-free survival of patients who choose
observation after an initial response to neoadjuvant chemotherapy.

- Compare the survival of patients treated with neoadjuvant chemotherapy followed by
cystectomy vs observation.

- Determine the feasibility, tolerability, and toxicity of these regimens in these
patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes and paclitaxel IV over 30 minutes on days 1
and 8 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 3
courses in the absence of disease progression or unacceptable toxicity.

Within 4-8 weeks after completion of neoadjuvant chemotherapy, patients undergo a third
transurethral resection of bladder tumor.

Patients with T0 disease after neoadjuvant chemotherapy may choose to undergo observation.
These patients undergo cystoscopies with biopsies every 3 months for 1 year, every 4 months
for 1 year, and then every 6 months until disease progression.

Patients with T1 disease or greater after neoadjuvant chemotherapy undergo immediate
cystectomy. Patients with T0 disease may also choose this option. Patients undergoing
immediate cystectomy are followed every 6 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: A total of 95 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed muscle-invasive (T2-T4a), node-negative (N0) urothelial
transitional cell cancer (TCC) of the bladder

- Focal squamous and/or adenocarcinoma differentiation, defined as ≤ 10% of tumor
volume allowed

- The following diagnoses are not allowed:

- Small cell carcinoma

- Sarcomatoid components

- Disease diagnosed with an initial transurethral resection of bladder tumor (TURBT)
and a second TURBT performed within 8 weeks of first with attempt to remove all tumor
present

- Residual disease after second TURBT allowed

- No more than 14-56 days after second TURBT

- No metastatic disease by chest x-ray and CT scan or MRI of the abdomen and pelvis

- Fresh tumor tissue, paraffin tumor tissue, unstained slides, or cell block specimen
from one or both TURBTs available

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-2

Life expectancy

- Not specified

Hematopoietic

- White blood cell count (WBC) at least 3,500/mm^3

- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least lower limit of normal

Hepatic

- Bilirubin no greater than 1.5 mg/dL

- Aspartate aminotransferase (SGOT) no greater than 2 times upper limit of normal

Renal

- Creatinine no greater than 2.0 mg/dL AND/OR

- Creatinine clearance at least 60 mL/min

Other

- No prohibitive medical risk that would preclude radical cystectomy

- No other serious concurrent systemic disorder that would preclude study compliance

- No other malignancy except adequately treated basal cell or squamous cell skin
cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer in
complete remission, or any other cancer for which patient has been disease-free for 5
years

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Prior intravesical immunotherapy allowed

Chemotherapy

- No prior systemic chemotherapy for TCC of the urothelium

- Prior intravesical chemotherapy allowed

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy for TCC of the urothelium

- No concurrent radiotherapy

Surgery

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Pathologic Complete Response Rate by Transurethral Resection of Bladder Tumor (TURBT) and Imaging Studies After Chemotherapy

Outcome Description:

Pathologic complete response (CR) is defined as absence of viable tumor in the TURBT specimen. Stable/No Response is defined as at least some disease evaluation tests were done (same tests as baseline) and status does not qualify for CR or Progression. Progression is defined as one or more of the following must occur: unequivocal progression of disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without documented progression or symptomatic deterioration.

Outcome Time Frame:

up to 12 weeks after registration (assessed within 8 weeks after completion of 3 cycles of chemotherapy )

Safety Issue:

No

Principal Investigator

Primo N. Lara, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, Davis

Authority:

United States: Federal Government

Study ID:

CDR0000256921

NCT ID:

NCT00045630

Start Date:

January 2003

Completion Date:

December 2011

Related Keywords:

  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Urethral Cancer
  • anterior urethral cancer
  • localized transitional cell cancer of the renal pelvis and ureter
  • posterior urethral cancer
  • stage II bladder cancer
  • stage III bladder cancer
  • transitional cell carcinoma of the bladder
  • urethral cancer associated with invasive bladder cancer
  • regional transitional cell cancer of the renal pelvis and ureter
  • Urinary Bladder Neoplasms
  • Urethral Neoplasms
  • Carcinoma, Transitional Cell
  • Kidney Neoplasms
  • Ureteral Neoplasms

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Foote HospitalJackson, Michigan  49201
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
Seton Cancer Institute - SaginawSaginaw, Michigan  48601
St. John Macomb HospitalWarren, Michigan  48093
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
CCOP - Grand RapidsGrand Rapids, Michigan  49503
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Scott and White HospitalTemple, Texas  76508
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
University of California Davis Cancer CenterSacramento, California  95817
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
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Latter Day Saints HospitalSalt Lake City, Utah  84143
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Legacy Emanuel Hospital and Health Center & Children's HospitalPortland, Oregon  97227
Banner Good Samaritan Medical CenterPhoenix, Arizona  85006
Banner Thunderbird Medical CenterPhoenix, Arizona  85306
North Colorado Medical CenterGreeley, Colorado  80631
McKee Medical CenterLoveland, Colorado  80539
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
Southwest Medical CenterLiberal, Kansas  67901
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Metropolitan HospitalGrand Rapids, Michigan  49506
Holland Community HospitalHolland, Michigan  49423
Hackley HospitalMuskegon, Michigan  49443
Munson Medical CenterTraverse City, Michigan  49684
Southeast Missouri Regional Cancer Center at Southeast Missouri HospitalGape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
Bozeman Deaconess HospitalBozeman, Montana  59715
St. James Community HospitalButte, Montana  59701
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
American Fork HospitalAmerican Fork, Utah  84003
Logan Regional HospitalLogan, Utah  84321
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
North Puget Oncology at United General HospitalSedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Spectrum Health Hospital - Butterworth CampusGrand Rapids, Michigan  49503
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Bay Regional Medical CenterBay City, Michigan  48708
Mecosta County Medical CenterBig Rapids, Michigan  49307
Providence Cancer Institute at Providence Hospital - Southfield CampusSouthfield, Michigan  48075
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Adirondack Cancer Care - Glens FallsGlens Falls, New York  12801
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Wilson Medical CenterWilson, North Carolina  27893-3428
Forsyth Regional Cancer Center at Forsyth Medical CenterWinston-Salem, North Carolina  27103
Legacy Mount Hood Medical CenterGresham, Oregon  97030
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer CenterPortland, Oregon  97210
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Legacy Meridian Park HospitalTualatin, Oregon  97062
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Danville Regional Medical CenterDanville, Virginia  24541
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Montrose Memorial Hospital Cancer CenterMontrose, Colorado  81401
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
St. Joseph Cancer CenterBellingham, Washington  98225
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Good Samaritan Cancer Center at Good Samaritan HospitalKearney, Nebraska  68848-1990
Rutherford HospitalRutherfordton, North Carolina  28139
AnMed Health Cancer CenterAnderson, South Carolina  29621
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Great Falls, Montana  59405
Sletten Regional Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Banner Baywood Medical CenterMesa, Arizona  85206
Banner Desert Medical CenterMesa, Arizona  85202
Christus Schumpert Cancer Treatment CenterShreveport, Louisiana  71101
University of Tennessee Cancer Institute - Medical CenterMemphis, Tennessee  38104
Cancer Center at Providence Alaska Medical CenterAnchorage, Alaska  99519-6604
Shaw Cancer Center at Vail Valley Medical CenterEdwards, Colorado  81632