Gemcitabine Hydrochloride, Cisplatin, and Sunitinib Malate as First-Line Therapy in Treating Patients With Locally Advanced And/or Metastatic Transitional Cell Carcinoma of the Urothelium (SUCCINCT)
NCT ID: NCT01089088
Last Updated: 2018-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2009-04-30
2014-10-31
Brief Summary
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PURPOSE: This phase II trial is studying the side effects of giving gemcitabine hydrochloride and cisplatin together with sunitinib malate and to see how well it works as first-line therapy in treating patients with locally advanced and/or metastatic transitional cell carcinoma of the urothelium.
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Detailed Description
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* To determine the activity, safety, and feasibility of gemcitabine hydrochloride and cisplatin in combination with sunitinib malate as first-line therapy in patients with locally advanced and/or metastatic transitional carcinoma of the urothelium.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, cisplatin IV over 3-4 hours on day 1, and oral sunitinib malate once daily on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 6 months and 1 year.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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cisplatin
Up to six 21 day chemotherapy cycles:
Cisplatin 70mg/m2 (IV day 1) Gemcitabine 1000mg/m2 (IV days 1 \& 8) Sunitinib 37.5mg (po days 2 to 15)
gemcitabine hydrochloride
Up to six 21 day chemotherapy cycles:
Cisplatin 70mg/m2 (IV day 1) Gemcitabine 1000mg/m2 (IV days 1 \& 8) Sunitinib 37.5mg (po days 2 to 15)
sunitinib malate
Up to six 21 day chemotherapy cycles:
Cisplatin 70mg/m2 (IV day 1) Gemcitabine 1000mg/m2 (IV days 1 \& 8) Sunitinib 37.5mg (po days 2 to 15)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients requiring anticoagulation may be entered on study after successful conversion to low molecular weight heparin
* No concurrent medications that have known adverse interactions with sunitinib malate (i.e., strong CYP3A4 inhibitors or inducers)
* No prior or concurrent live vaccines (e.g., measles, mumps, rubella, oral polio, bacille Calmette-Guérin \[BCG\], yellow fever, varicella, and TY21a typhoid vaccines)
16 Years
120 Years
ALL
No
Sponsors
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Cardiff University
OTHER
Responsible Party
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Lisette Nixon
Senior Trial Manager
Principal Investigators
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Tom Geldart
Role: PRINCIPAL_INVESTIGATOR
Royal Bournemouth Hospital
Locations
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Bristol Haematology and Oncology Centre
Bristol, Avon, United Kingdom
Castle Hill Hospital
Cottingham, East Yorkshire, United Kingdom
Royal Bournemouth Hospital
Bournemouth, England, United Kingdom
Churchill Hospital
Oxford, Oxfordshire, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, Shropshire, United Kingdom
The Royal Marsden Hospitals (Surrey)
Sutton, Surrey, United Kingdom
St James's University Hospital
Leeds, Yorkshire, United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
Velindre Hospital
Cardiff, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
St Mary's Hospital (Paddington)
London, , United Kingdom
Charing Cross Hospital
London, , United Kingdom
Christie Hospital
Manchester, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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References
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Chang SS. Re: SUCCINCT: An Open-Label, Single-Arm, Non-Randomised, Phase 2 Trial of Gemcitabine and Cisplatin Chemotherapy in Combination with Sunitinib as First-Line Treatment for Patients with Advanced Urothelial Carcinoma. J Urol. 2015 Dec;194(6):1583-4. doi: 10.1016/j.juro.2015.09.005. Epub 2015 Sep 5. No abstract available.
Related Links
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Trial Publication link
Other Identifiers
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WCTU-SUCCINCT
Identifier Type: -
Identifier Source: secondary_id
ISRCTN54607216
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2007-007591-42
Identifier Type: -
Identifier Source: secondary_id
EU-21013
Identifier Type: -
Identifier Source: secondary_id
WCTU-SPON-416-07
Identifier Type: -
Identifier Source: secondary_id
CRUK-07/044
Identifier Type: -
Identifier Source: secondary_id
CDR0000667764
Identifier Type: -
Identifier Source: org_study_id
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