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

• Register: ClinicalTrials.gov
• Last refreshed on: 4 March 2013
• Main ID: NCT01089088
• Date of registration: 17/03/2010
• Primary sponsor: Wales Cancer Trials Unit
• Public title: 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
• Scientific 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
• Date of first enrolment: April 2009
• Target sample size: 63
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01089088
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United Kingdom

Contacts

• Name: Tom Geldart
• Affiliation: Royal Bournemouth Hospital

Key inclusion & exclusion criteria

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)



Age minimum: 16 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Bladder Cancer

Transitional Cell Cancer of the Renal Pelvis and Ureter

Urethral Cancer

Intervention(s)

Drug: cisplatin

Drug: gemcitabine hydrochloride

Drug: sunitinib malate

Primary Outcome(s)

Progression-free survival [Time Frame: 6 months]

Secondary Outcome(s)

Objective (radiological) response rate according to RECIST [Time Frame: 1 year]

Overall survival [Time Frame: 3 years]

Progression-free survival (time-to-event) [Time Frame: 1 year]

Tolerability (side effects) and feasibility of use (number of patients requiring dose delays or reduction and/or treatment withdrawal) [Time Frame: 1 year]

Toxicity during and after treatment according to NCI CTCAE v 3.0 [Time Frame: 1 Year]

Secondary ID(s)

CDR0000667764

CRUK-07/044

EU-21013

EUDRACT-2007-007591-42

ISRCTN54607216

WCTU-SPON-416-07

WCTU-SUCCINCT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cardiff University