Cisplatin Plus Gemcitabine With or Without Paclitaxel in Treating Patients With Stage IV Urinary Tract Cancer

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompleted18 and overNCI, OtherEORTC-30987

Trial Description


RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for urinary tract cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus gemcitabine with or without paclitaxel in treating patients who have stage IV urinary tract cancer.

Further Study Information


  • 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.

Eligibility Criteria


  • 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



  • 18 and over

Performance status:

  • WHO 0-1

Life expectancy:

  • At least 12 weeks


  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL


  • Bilirubin less than 1.25 times normal
  • AST or ALT less than 2.5 times normal


  • Glomerular filtration rate at least 60 mL/min
  • Calcium normal or clinically insignificant


  • 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


  • 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)


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


  • No prior systemic chemotherapy
  • At least 4 weeks since prior local intravesical chemotherapy

Endocrine therapy:

  • Not specified


  • See Disease Characteristics
  • No more than 1 prior course of radiotherapy
  • At least 4 weeks since prior radiotherapy and recovered


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

Trial Contact Information

Trial Lead Organizations/Sponsors

European Organization for Research and Treatment of Cancer

  • National Cancer Institute
  • Groupe D'Etude des Tumeurs Uro-Genitales
  • Institute of Cancer Research - Sutton
  • Central European Cooperative Oncology Group
  • NCIC-Clinical Trials Group
  • Southwest Oncology Group
  • German Association of Urologic Oncology
  • Spanish Oncology Genito-Urinary Group
  • Medical Research Council's Working Party on Leukemia in Adults and Children
Joaquim Bellmunt, Study Chair
Stephane Culine, MD, Study Chair
Michael Leahy, Study Chair
Christoph Zielinski, Study Chair
Malcolm J. Moore, Study Chair
David C. Smith, Study Chair
Andreas Boehle, MD, Study Chair
Jose Baselga, Study Chair

Link to the current record.
NLM Identifier NCT00022191 processed this data on April 09, 2015

Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to