- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00014274
Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium
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
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
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Salzburg, Austria, A-5020
- St. Johanns-Spital
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Vienna, Austria, A-1100
- Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
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Aalst, Belgium, B-9300
- Onze Lieve Vrouw Ziekenhuis Aalst
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Brussels, Belgium, 1000
- Institut Jules Bordet
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Edegem, Belgium, B-2650
- Universitair Ziekenhuis Antwerpen
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Kortrijk, Belgium, 8500
- AZ Groeninge - Oncologisch Centrum
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Copenhagen, Denmark, 2100
- Rigshospitalet - Copenhagen University Hospital
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Nuernberg, Germany, D-90419
- Klinikum Nuernberg - Klinikum Nord
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Budapest, Hungary, 1125
- National Institute of Oncology
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Zerifin, Israel, 70300
- Assaf Harofeh Medical Center
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Palermo, Italy, 90145
- Università di Palermo
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Varese, Italy, 21100
- Ospedale di Circolo e Fondazione Macchi
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's-Hertogenbosch, Netherlands, 5211 NL
- Jeroen Bosch Ziekenhuis
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Amsterdam, Netherlands, 1066 CX
- Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
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Amsterdam, Netherlands, 1105 AZ
- Academisch Medisch Centrum at University of Amsterdam
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Leiden, Netherlands, 2300 CA
- Leiden University Medical Center
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Nijmegen, Netherlands, NL-6500 HB
- Universitair Medisch Centrum St. Radboud - Nijmegen
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Rotterdam, Netherlands, 3000 CA
- University Medical Center Rotterdam at Erasmus Medical Center
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Utrecht, Netherlands, 3584 CX
- University Medical Center Utrecht
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Warsaw, Poland, 02-781
- Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
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Barcelona, Spain, 08036
- Hospital Clinic De Barcelona
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Barcelona, Spain, 08025
- Hospital de la Santa Cruz i Sant Pau
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Barcelona, Spain, 08035
- Vall D'Hebron University Hospital
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Madrid, Spain, 28040
- Hospital Universitario San Carlos
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Valencia, Spain, 46009
- Instituto Valenciano de Oncología
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England
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Southampton, England, United Kingdom, SO16 6YD
- Southampton General Hospital
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Southampton, England, United Kingdom, SO14 0YG
- Royal South Hants Hospital
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Southampton, England, United Kingdom, SO14 0YG
- Leeds Cancer Centre at St. James's University Hospital
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Sutton, England, United Kingdom, SM2 5PT
- Royal Marsden - Surrey
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Duration of survival
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Secondary Outcome Measures
Outcome Measure |
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Toxicity as assessed by CTC v2
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Response as assessed by RECIST criteria
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Collaborators and Investigators
Investigators
- Study Chair: Gerwin Kaiser, MD, Klinikum Nuernberg - Klinikum Nord
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage III bladder cancer
- stage IV bladder cancer
- metastatic transitional cell cancer of the renal pelvis and ureter
- transitional cell carcinoma of the bladder
- urethral cancer associated with invasive bladder cancer
- regional transitional cell cancer of the renal pelvis and ureter
- anterior urethral cancer
- posterior urethral cancer
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Urinary Bladder Diseases
- Ureteral Diseases
- Urethral Diseases
- Kidney Neoplasms
- Urinary Bladder Neoplasms
- Carcinoma, Transitional Cell
- Ureteral Neoplasms
- Urethral Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Gemcitabine
- Carboplatin
- Methotrexate
- Vinblastine
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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