Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium

June 11, 2013 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Randomized Phase II/III Study Assessing Gemcitabine/Carboplatin And Methotrexate/Carboplatin/Vinblastine In Previously Untreated Patients With Advanced Urothelial Cancer Ineligible For Cisplatin Based Chemotherapy

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective for transitional cell cancer of the urothelium.

PURPOSE: Randomized phase II/III trial to compare different combination chemotherapy regimens in treating patients who have transitional cell cancer of the urothelium.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the antitumor activity of gemcitabine and carboplatin vs methotrexate, carboplatin, and vinblastine in patients with transitional cell cancer of the urothelium who are ineligible for cisplatin-based chemotherapy.
  • Compare the toxicity and acute and intermediate (1-2 years) side effects of these regimens in these patients.
  • Compare the complete response rates, progression-free survival, and overall survival of patients treated with these regimens.
  • Compare the symptoms and quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive methotrexate* IV and vinblastine IV on days 1, 15, and 22 and carboplatin IV over 1 hour on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

NOTE: * Methotrexate is omitted for patients with pleural effusion or ascites until complete resolution and for patients with a glomerular filtration rate less than 30 mL/min or creatinine greater than 2 mg/dL

Patients in either arm who achieve a complete response (CR) receive 2 additional courses of chemotherapy beyond CR.

Quality of life is assessed at baseline, after every 2 courses of chemotherapy, and within 6 weeks of completion of therapy.

Patients are followed within 6 weeks, every 3 months for 1 year, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 156 patients (78 per treatment arm) will be accrued for the phase II portion of this study. A total of 225 patients will be accrued for the phase II + III portions of this study within 5 years.

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, A-5020
        • St. Johanns-Spital
      • Vienna, Austria, A-1100
        • Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
  • Belgium
      • Aalst, Belgium, B-9300
        • Onze Lieve Vrouw Ziekenhuis Aalst
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Edegem, Belgium, B-2650
        • Universitair Ziekenhuis Antwerpen
      • Kortrijk, Belgium, 8500
        • AZ Groeninge - Oncologisch Centrum
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet - Copenhagen University Hospital
  • Germany
      • Nuernberg, Germany, D-90419
        • Klinikum Nuernberg - Klinikum Nord
  • Hungary
      • Budapest, Hungary, 1125
        • National Institute of Oncology
  • Israel
      • Zerifin, Israel, 70300
        • Assaf Harofeh Medical Center
  • Italy
      • Palermo, Italy, 90145
        • Università di Palermo
      • Varese, Italy, 21100
        • Ospedale di Circolo e Fondazione Macchi
  • Netherlands
      • 's-Hertogenbosch, Netherlands, 5211 NL
        • Jeroen Bosch Ziekenhuis
      • Amsterdam, Netherlands, 1066 CX
        • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum at University of Amsterdam
      • Leiden, Netherlands, 2300 CA
        • Leiden University Medical Center
      • Nijmegen, Netherlands, NL-6500 HB
        • Universitair Medisch Centrum St. Radboud - Nijmegen
      • Rotterdam, Netherlands, 3000 CA
        • University Medical Center Rotterdam at Erasmus Medical Center
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht
  • Poland
      • Warsaw, Poland, 02-781
        • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic De Barcelona
      • Barcelona, Spain, 08025
        • Hospital de la Santa Cruz i Sant Pau
      • Barcelona, Spain, 08035
        • Vall D'Hebron University Hospital
      • Madrid, Spain, 28040
        • Hospital Universitario San Carlos
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncología
  • United Kingdom
    • England
      • Southampton, England, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Southampton, England, United Kingdom, SO14 0YG
        • Royal South Hants Hospital
      • Southampton, England, United Kingdom, SO14 0YG
        • Leeds Cancer Centre at St. James's University Hospital
      • Sutton, England, United Kingdom, SM2 5PT
        • Royal Marsden - Surrey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed transitional cell cancer of the urothelium, including the renal pelvis, ureters, urinary bladder, and urethra, meeting 1 of the following criteria:

    • Unresected positive lymph node
    • Distant metastases (M1, stage IV)
    • Unresectable primary bladder cancer (T3-4)
  • Measurable disease

  • Ineligible for cisplatin-based chemotherapy and presenting with the following:

    • WHO performance status 2 AND/OR
    • Glomerular filtration rate greater than 30 mL/min but less than 60 mL/min
  • No brain metastases or other CNS lesions

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • See Disease Characteristics

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 4,000/mm^3
  • Platelet count at least 125,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.25 times normal
  • AST/ALT no greater than 3 times normal (5 times normal if liver metastases are present)

Renal:

  • See Disease Characteristics
  • Calcium normal

Other:

  • Not pregnant or nursing
  • 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 participation
  • No other prior or concurrent malignancy except cured basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior systemic biologic therapy

Chemotherapy:

  • See Disease Characteristics
  • No prior systemic cytotoxic therapy (including adjuvant and neoadjuvant chemotherapy)

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 3 months since prior radiotherapy
  • Prior radiotherapy to study lesions allowed if there is evidence of disease progression

Surgery:

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Duration of survival

Secondary Outcome Measures

Outcome Measure
Toxicity as assessed by CTC v2
Response as assessed by RECIST criteria

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Gerwin Kaiser, MD, Klinikum Nuernberg - Klinikum Nord

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Primary Completion (ACTUAL)

March 1, 2008

Study Registration Dates

First Submitted

April 10, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

June 12, 2013

Last Update Submitted That Met QC Criteria

June 11, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-30986
  • EORTC-GU-30986

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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