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AzTrials

Bladder CancerPhase 2NCT01089088

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)

A Phase 2 study testing cisplatin, gemcitabine hydrochloride and sunitinib malate in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by Cardiff University at 16 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 120 years
What is being tested?
cisplatin, gemcitabine hydrochloride and sunitinib malate
Type of treatment
Injection or infusion
How many people
63 participants
Where
16 sitesUnited Kingdom
Study dates
Apr 2009to Oct 2014
Phase
Phase 2
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 16 to 120 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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)

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United Kingdom16 sites

  • Royal Bournemouth Hospital

    Bournemouth, England, BH7 7DW

  • Bristol Haematology and Oncology Centre

    Bristol, Avon, BS2 8ED

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • Velindre Hospital

    Cardiff, CF14 2TL

  • Castle Hill Hospital

    Cottingham, East Yorkshire, HU16 5JQ

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • St James's University Hospital

    Leeds, Yorkshire, LS9 7TF

  • St Bartholomew's Hospital

    London, EC1A 7BE

  • Hammersmith Hospital

    London, W12 0HS

  • St Mary's Hospital (Paddington)

    London, W2 1NY

  • Charing Cross Hospital

    London, W6 8RF

  • Christie Hospital

    Manchester, M20 4BX

  • Churchill Hospital

    Oxford, Oxfordshire, OX3 7LJ

  • Royal Shrewsbury Hospital

    Shrewsbury, Shropshire, SY3 8XQ

  • Southampton General Hospital

    Southampton, SO16 6YD

  • The Royal Marsden Hospitals (Surrey)

    Sutton, Surrey, Surrey

Other trials in United Kingdom

About this study

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

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.

Read the detailed description

OBJECTIVES:

  • 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

Being tested
cisplatin, gemcitabine hydrochloride, sunitinib malate
Keywords
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
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.

  • cisplatinDrug

    Also called Sutent

    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 hydrochlorideDrug

    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 malateDrug

    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)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    Proportion of patients progression free at 6 months

    Measured: 6 months

Secondary outcomes (5)

  1. Toxicity during and after treatment according to NCI CTCAE v 3.0

    Measured: 1 Year

  2. Tolerability (side effects) and feasibility of use (number of patients requiring dose delays or reduction and/or treatment withdrawal)

    Measured: 1 year

  3. Overall survival

    Measured: 3 years

  4. Progression-free survival (time-to-event)

    Measured: 1 year

  5. Objective (radiological) response rate according to RECIST

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2010 (estimated)
  2. Study startApr 2009
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01089088
Sponsor's protocol ID
CDR0000667764
Other IDs
WCTU-SUCCINCT, ISRCTN54607216, EUDRACT-2007-007591-42, EU-21013, WCTU-SPON-416-07, CRUK-07/044
Status last verified
Feb 2013
First submitted
17 Mar 2010
Last updated
26 Oct 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26582660

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin, gemcitabine hydrochloride and sunitinib malate in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by Cardiff University at 16 sites in United Kingdom.

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 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United Kingdom. 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 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.

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?

Progression-free survival (time frame: 6 months). 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 NCT01089088, which also lists 1 linked publication.

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 26 Oct 2018.

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