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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01089088
Recruitment Status : Completed
First Posted : March 18, 2010
Last Update Posted : October 26, 2018
Information provided by (Responsible Party):
Lisette Nixon, Cardiff University

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving gemcitabine hydrochloride and cisplatin together with sunitinib malate may kill more tumor cells.

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer Drug: cisplatin Drug: gemcitabine hydrochloride Drug: sunitinib malate Phase 2

Detailed Description:


  • 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Single-Arm Trial to Evaluate Cisplatin and Gemcitabine Chemotherapy in Combination With Sunitinib for First-Line Treatment of Patients With Advanced Transitional Carcinoma of the Urothelium
Study Start Date : April 2009
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Intervention Details:
  • Drug: 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)

    Other Name: Sutent
  • Drug: 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)

  • Drug: 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)

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 6 months ]
    Proportion of patients progression free at 6 months

Secondary Outcome Measures :
  1. Toxicity during and after treatment according to NCI CTCAE v 3.0 [ Time Frame: 1 Year ]
  2. Tolerability (side effects) and feasibility of use (number of patients requiring dose delays or reduction and/or treatment withdrawal) [ Time Frame: 1 year ]
  3. Overall survival [ Time Frame: 3 years ]
  4. Progression-free survival (time-to-event) [ Time Frame: 1 year ]
  5. Objective (radiological) response rate according to RECIST [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed transitional cell carcinoma of the urothelium

    • Pure or mixed histology
    • Upper or lower urinary tract
  • Radiologically measurable, locally advanced and/or metastatic disease not amenable to curative treatment with surgery or radiotherapy meeting 1 of the following criteria:

    • T4b (bladder) or T4 (renal pelvis/ureter), any N, any M
    • Any T, N2-3, any M
    • Any T, any N, M1
  • No urothelial cancer for which subsequent radical treatment is being considered with a view to possibly cure the disease
  • No history of CNS metastases


  • WHO performance status 0-2
  • Life expectancy > 3 months
  • Absolute neutrophil count ≥ 1.5 x 10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT and ALP ≤ 2.5 times ULN
  • GFR ≥ 60 mL/min (uncorrected for surface area and measured by isotopic means)
  • PT or INR ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Fit to receive cisplatin-containing combination chemotherapy
  • No previous malignancy other than nonmelanoma skin cancer, carcinoma in situ of the cervix, or incidental localized prostate cancer
  • No known HIV positivity or chronic hepatitis B or C infection
  • No uncontrolled hypertension
  • No symptomatic coronary artery disease, myocardial infarction within the past 6 months, congestive cardiac failure (NYHA class III-IV disease), or uncontrolled or symptomatic cardiac arrhythmia
  • No clinically significant bacterial or fungal infection
  • No concurrent grapefruit juice


  • At least 1 month since prior radiotherapy or radiotherapy involving more than 30% of total bone marrow volume
  • At least 1 month since prior investigational drug
  • No prior systemic therapy for locally advanced or metastatic disease

    • Patients who have received prior neoadjuvant or adjuvant chemotherapy for urothelial cancer (up to 4 courses), completed at least 6 months prior to first documented disease progression, are eligible
  • No concurrent anticoagulant therapy with warfarin or unfractionated heparin

    • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01089088

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United Kingdom
Bristol Haematology and Oncology Centre
Bristol, Avon, United Kingdom, BS2 8ED
Castle Hill Hospital
Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
Royal Bournemouth Hospital
Bournemouth, England, United Kingdom, BH7 7DW
Churchill Hospital
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
Royal Shrewsbury Hospital
Shrewsbury, Shropshire, United Kingdom, SY3 8XQ
The Royal Marsden Hospitals (Surrey)
Sutton, Surrey, United Kingdom, Surrey
St James's University Hospital
Leeds, Yorkshire, United Kingdom, LS9 7TF
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Velindre Hospital
Cardiff, United Kingdom, CF14 2TL
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Hammersmith Hospital
London, United Kingdom, W12 0HS
St Mary's Hospital (Paddington)
London, United Kingdom, W2 1NY
Charing Cross Hospital
London, United Kingdom, W6 8RF
Christie Hospital
Manchester, United Kingdom, M20 4BX
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Cardiff University
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Principal Investigator: Tom Geldart Royal Bournemouth Hospital
Additional Information:
Publications of Results:
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Responsible Party: Lisette Nixon, Senior Trial Manager, Cardiff University Identifier: NCT01089088    
Other Study ID Numbers: CDR0000667764
First Posted: March 18, 2010    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: February 2013
Keywords provided by Lisette Nixon, Cardiff University:
recurrent urethral cancer
recurrent transitional cell cancer of the renal pelvis and ureter
metastatic transitional cell cancer of the renal pelvis and ureter
regional transitional cell cancer of the renal pelvis and ureter
posterior urethral cancer
urethral cancer associated with invasive bladder cancer
transitional cell carcinoma of the bladder
stage IV bladder cancer
recurrent bladder cancer
anterior urethral cancer
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urethral Neoplasms
Kidney Neoplasms
Ureteral Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Urethral Diseases
Kidney Diseases
Ureteral Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs