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Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients With Metastatic or Locally Advanced Urothelial Cancer Without Prior Systemic Therapy


Phase 3
18 Years
N/A
Not Enrolling
Both
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer

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Trial Information

Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients With Metastatic or Locally Advanced Urothelial Cancer Without Prior Systemic Therapy


OBJECTIVES:

- Compare the duration of survival of patients with stage IV transitional cell carcinoma
of the urothelium treated with cisplatin and gemcitabine with or without paclitaxel.

- Compare the duration of progression-free survival, response rates, and duration of
response in patients treated with these regimens.

- Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to participating center, WHO performance status (0 vs 1), and presence of
metastatic disease (yes vs no). Patients are randomized to one of two treatment arms.

- Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and
cisplatin IV over 1 hour on day 1 or 2. Treatment repeats every 28 days for a maximum
of 6 courses in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive paclitaxel IV over 1 hour on days 1 and 8 followed by
cisplatin IV over 1 hour on day 1 and gemcitabine IV over 30 minutes on days 1 and 8.
Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease
progression or unacceptable toxicity.

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

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 610 patients (305 per treatment arm) will be accrued for this
study within 3.04 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage IV transitional cell carcinoma of the urothelium (pure
or mixed) including bladder, urethra, ureter, and renal pelvis

- T4b, any N OR any T, N2-3 OR M1

- Ineligible for surgery or radiotherapy with curative intent

- Measurable or evaluable disease

- No known CNS metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- WHO 0-1

Life expectancy:

- At least 12 weeks

Hematopoietic:

- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 10 g/dL

Hepatic:

- Bilirubin less than 1.25 times normal

- AST or ALT less than 2.5 times normal

Renal:

- Glomerular filtration rate at least 60 mL/min

- Calcium normal or clinically insignificant

Cardiovascular:

- No clinically significant cardiac arrhythmia

- No congestive heart failure

- No complete bundle branch block

- No New York Heart Association class III or IV heart disease

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study
participation

- No psychological, familial, sociological, or geographical condition that would
preclude study compliance

- No grade 3 or 4 infection without neutropenia

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

- No mental disorder that would preclude study compliance

- No grade II or greater neuropathy

- No other prior or concurrent malignancy except appropriately treated carcinoma in
situ of the cervix, basal cell carcinoma of the skin, or incidental prostate cancer
(T1, Gleason score no greater than 6, and PSA less than 0.5 ng/mL)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior investigational biologic agents (e.g., antiangiogenic products, signal
transduction pathway inhibitors, immunomodulators, or monoclonal antibody therapy)

- At least 4 weeks since prior immunotherapy

Chemotherapy:

- No prior systemic chemotherapy

- At least 4 weeks since prior local intravesical chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- No more than 1 prior course of radiotherapy

- At least 4 weeks since prior radiotherapy and recovered

Surgery:

- See Disease Characteristics

- Prior urological procedures to relieve urinary tract obstruction and improve renal
function allowed (e.g., ureteral stent or percutaneous nephrostomy)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Joaquim Bellmunt, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Vall d'Hebron University Hospital

Authority:

United States: Federal Government

Study ID:

EORTC-30987

NCT ID:

NCT00022191

Start Date:

May 2001

Completion Date:

Related Keywords:

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

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Kansas CityKansas City, Missouri  64131
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
Tulane University School of MedicineNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
Harrington Cancer CenterAmarillo, Texas  79106
University of Texas Medical BranchGalveston, Texas  77555-1329
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer CenterOrange, California  92868
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
Veterans Affairs Medical Center - Little Rock (McClellan)Little Rock, Arkansas  72205
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Veterans Affairs Medical Center - BiloxiBiloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
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 - Salt Lake CitySalt Lake City, Utah  84148
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
University of California Davis Cancer CenterSacramento, California  95817
City of Hope Comprehensive Cancer CenterDuarte, California  91010
University of Tennessee Cancer InstituteMemphis, Tennessee  38103
Veterans Affairs Medical Center - AmarilloAmarillo, Texas  79106
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
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
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
St. Louis University Hospital Cancer CenterSaint Louis, Missouri  63110
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
St. Mary's - Duluth Clinic Cancer CenterDuluth, Minnesota  55805
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Oklahoma University Medical Center at University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73126
Providence Cancer Institute at Providence HospitalSouthfield, Michigan  48075
Southwest Cancer and Research Center at University Medical CenterLubbock, Texas  79415-3364
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesDel Rio, Texas  78840