Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium
NCT ID: NCT00014274
Last Updated: 2013-06-12
Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
238 participants
INTERVENTIONAL
2001-01-31
Brief Summary
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PURPOSE: Randomized phase II/III trial to compare different combination chemotherapy regimens in treating patients who have transitional cell cancer of the urothelium.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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carboplatin
gemcitabine hydrochloride
methotrexate
vinblastine sulfate
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Gerwin Kaiser, MD
Role: STUDY_CHAIR
Klinikum Nuernberg - Klinikum Nord
Locations
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St. Johanns-Spital
Salzburg, , Austria
Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
Vienna, , Austria
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, , Belgium
Institut Jules Bordet
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
AZ Groeninge - Oncologisch Centrum
Kortrijk, , Belgium
Rigshospitalet - Copenhagen University Hospital
Copenhagen, , Denmark
Klinikum Nuernberg - Klinikum Nord
Nuremberg, , Germany
National Institute of Oncology
Budapest, , Hungary
Assaf Harofeh Medical Center
Ẕerifin, , Israel
Universita Di Palermo
Palermo, , Italy
Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, , Netherlands
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Universitair Medisch Centrum St. Radboud - Nijmegen
Nijmegen, , Netherlands
University Medical Center Rotterdam at Erasmus Medical Center
Rotterdam, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, , Poland
Hospital de la Santa Cruz i Sant Pau
Barcelona, , Spain
Vall d'Hebron University Hospital
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario San Carlos
Madrid, , Spain
Instituto Valenciano De Oncologia
Valencia, , Spain
Leeds Cancer Centre at St. James's University Hospital
Southampton, England, United Kingdom
Royal South Hants Hospital
Southampton, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Countries
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References
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De Santis M, Bellmunt J, Mead G, Kerst JM, Leahy M, Maroto P, Gil T, Marreaud S, Daugaard G, Skoneczna I, Collette S, Lorent J, de Wit R, Sylvester R. Randomized phase II/III trial assessing gemcitabine/carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer who are unfit for cisplatin-based chemotherapy: EORTC study 30986. J Clin Oncol. 2012 Jan 10;30(2):191-9. doi: 10.1200/JCO.2011.37.3571. Epub 2011 Dec 12.
De Santis M, Bellmunt J, Mead G, Kerst JM, Leahy M, Maroto P, Skoneczna I, Marreaud S, de Wit R, Sylvester R. Randomized phase II/III trial assessing gemcitabine/ carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer "unfit" for cisplatin-based chemotherapy: phase II--results of EORTC study 30986. J Clin Oncol. 2009 Nov 20;27(33):5634-9. doi: 10.1200/JCO.2008.21.4924. Epub 2009 Sep 28.
De Santis M, Bellmunt J, Mead B, et al.: Randomized phase II/III study assessing gemcitabine/carboplatin (GC) and methotrexate/carboplatin/vinblastine (M-CAVI) in previously untreated patients (pts) with advanced urothelial cancer ineligible for cisplatin based chemotherapy: phase II results of. [Abstract] American Society of Clinical Oncology 2008 Genitourinary Cancers Symposium, Feb 14-16, 2008, San Francisco, CA. A-288, 2008.
Other Identifiers
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EORTC-GU-30986
Identifier Type: -
Identifier Source: secondary_id
EORTC-30986
Identifier Type: -
Identifier Source: org_study_id
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