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)

NCT01089088 | Completed Phase 2 DMC

• 7 other identifiers: CDR0000667764WCTU-SUCCINCTISRCTN54607216EUDRACT-2007-007591-42EU-21013WCTU-SPON-416-07CRUK-07/044
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 16

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.

Conditions

Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer

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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Proportion of patients progression free at 6 months

  6 months

Secondary Outcomes (5)

• Toxicity during and after treatment according to NCI CTCAE v 3.0

  1 Year

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

  1 year

• Overall survival

  3 years

• Progression-free survival (time-to-event)

  1 year

• Objective (radiological) response rate according to RECIST

  1 year

Interventions

cisplatin DRUG

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)

Also known as: Sutent

gemcitabine hydrochloride DRUG

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 DRUG

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)

Eligibility Criteria

• Age: 16 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cardiff University: lead

Study Sites (16)

Bristol Haematology and Oncology Centre

Bristol, Avon, BS2 8ED, United Kingdom

Location

Castle Hill Hospital

Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, England, BH7 7DW, United Kingdom

Location

Churchill Hospital

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

Location

Royal Shrewsbury Hospital

Shrewsbury, Shropshire, SY3 8XQ, United Kingdom

Location

The Royal Marsden Hospitals (Surrey)

Sutton, Surrey, Surrey, United Kingdom

Location

St James's University Hospital

Leeds, Yorkshire, LS9 7TF, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Velindre Hospital

Cardiff, CF14 2TL, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

St Mary's Hospital (Paddington)

London, W2 1NY, United Kingdom

Location

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 26582660 RESULT

Related Links

• Summary on sponsor website
• Trial Publication link

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Urethral Neoplasms

Interventions

Cisplatin; Sunitinib; Gemcitabine

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Urethral Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines

Study Officials

• Tom Geldart

  Royal Bournemouth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Trial Manager

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 18, 2010
• Study Start: April 1, 2009
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 26, 2018

Record last verified: 2013-02

Locations

GB (16)