Bladder CancerPhase 2/3NCT00014274
Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium
A Phase 2/3 study testing carboplatin, gemcitabine hydrochloride and methotrexate in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by European Organisation for Research and Treatment of Cancer - EORTC at 29 sites in 11 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
- What is being tested?
- carboplatin, gemcitabine hydrochloride and methotrexate
- How many people
- 238 participants
- Where
- 29 sitesin 11 countries
- Study dates
- Jan 2001to Mar 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
29 sites in 11 countries.
29 sites in 11 countries
Netherlands7 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5211 NL
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, 1066 CX
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, 1105 AZ
Leiden University Medical Center
Leiden, 2300 CA
Universitair Medisch Centrum St. Radboud - Nijmegen
Nijmegen, NL-6500 HB
University Medical Center Rotterdam at Erasmus Medical Center
Rotterdam, 3000 CA
University Medical Center Utrecht
Utrecht, 3584 CX
Spain5 sites
Hospital de la Santa Cruz i Sant Pau
Barcelona, 08025
Vall d'Hebron University Hospital
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitario San Carlos
Madrid, 28040
Instituto Valenciano De Oncologia
Valencia, 46009
Belgium4 sites
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, B-9300
Institut Jules Bordet
Brussels, 1000
Universitair Ziekenhuis Antwerpen
Edegem, B-2650
AZ Groeninge - Oncologisch Centrum
Kortrijk, 8500
United Kingdom4 sites
Leeds Cancer Centre at St. James's University Hospital
Southampton, England, SO14 0YG
Royal South Hants Hospital
Southampton, England, SO14 0YG
Southampton General Hospital
Southampton, England, SO16 6YD
Royal Marsden - Surrey
Sutton, England, SM2 5PT
Austria2 sites
St. Johanns-Spital
Salzburg, A-5020
Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
Vienna, A-1100
Italy2 sites
Universita Di Palermo
Palermo, 90145
Ospedale di Circolo e Fondazione Macchi
Varese, 21100
Denmark1 site
Rigshospitalet - Copenhagen University Hospital
Copenhagen, 2100
Poland1 site
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, 02-781
About this study
Official title: 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.
Read the 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.
- Being tested
- carboplatin, gemcitabine hydrochloride, methotrexate, vinblastine sulfate
- Keywords
- stage III bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder, anterior urethral cancer, posterior urethral cancer, 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
- Medical subject headings
- Urinary Bladder Neoplasms, Urethral Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
methotrexateDrug
vinblastine sulfateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of survival
Secondary outcomes (2)
Response as assessed by RECIST criteria
Toxicity as assessed by CTC v2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJan 2001
- Primary completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Gerwin Kaiser, MD, Study chair, Klinikum Nuernberg - Klinikum Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00014274
- Sponsor's protocol ID
- EORTC-30986
- Other IDs
- EORTC-GU-30986
- Status last verified
- Jun 2013
- First submitted
- 10 Apr 2001
- Last updated
- 12 Jun 2013
- Results posted
- No
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.
PubMed 22162575De 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.
PubMed 19786668De 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 at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00014274
- Acronym / sponsor ID
- EORTC-30986
- Keywords
- stage III bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder, anterior urethral cancer, posterior urethral cancer, 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
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Jan 2001
- Primary completion
- Mar 2008 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carboplatin | Drug | – |
| gemcitabine hydrochloride | Drug | – |
| methotrexate | Drug | – |
| vinblastine sulfate | Drug | – |
Primary outcome
Duration of survival
2 secondary outcomes
Response as assessed by RECIST criteria
Toxicity as assessed by CTC v2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2013.
- Results publication: PubMed 22162575De 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.
- Results publication: PubMed 19786668De 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.
- Results publicationDe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerwin Kaiser, MD study chair
Klinikum Nuernberg - Klinikum Nord
29 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing carboplatin, gemcitabine hydrochloride and methotrexate in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by European Organisation for Research and Treatment of Cancer - EORTC at 29 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Netherlands, Spain, Belgium, United Kingdom, Austria and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00014274, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2013.