Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy for TCC

Stopped early · Phase 2

Conditions studied: Transitional Cell Carcinoma of the Bladder

In brief

This trial will investigate the activity of sunitinib combined with cisplatin and gemcitabine followed by radical cystectomy in patients with Transitional Cell Carcinoma (TCC) of the Bladder.

Key facts

Study ID

NCT00859339

Run by

Noah Hahn, M.D.

People needed

9

Starts

2009-03-01

Expected to finish

2011-04-01

Last updated by the study team

2016-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological proof of muscle-invasive transitional cell carcinoma of the bladder (stage II-III) with no evidence of metastatic disease (focal squamous and/or adenocarcinoma differentiation allowed, sarcomatoid and small-cell components not allowed). Patient with any degree of fixation of the pelvic sidewall are not eligible.
• Must be willing to undergo a cystoscopy if tumor block is not available prior to registration for protocol therapy.
• Eligible for radical cystectomy as per the attending urologist.
• Prior radiation therapy to bone marrow is allowed to < 25% of the marrow, and must be completed at least 6 months prior to registration for protocol therapy
• Written informed consent and HIPAA authorization for release of personal health information.
• Age > 18 years at the time of consent.
• Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.
• Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.

You may not qualify if…

• No prior radiotherapy to the pelvis.
• No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason< grade 7 prostate cancers, or other cancer for which the patient has been disease-free for at least 5 years.
• No treatment with any investigational agent within 30 days prior to registration for protocol therapy.
• No cerebrovascular accident or transient ischemic attack within 6 months prior to registration for protocol therapy.
• No evidence of pulmonary embolism within 6 months prior to registration for protocol therapy.
• No uncontrolled hypertension (>150/100 mm Hg despite optimal medical therapy).
• No evidence of ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade 2.
• No history of uncontrolled/untreated thyroid dysfunction.
• No prolonged QTc interval (> 450 msec) on pre-entry electrocardiogram obtained within 28 days prior to being registered on study.
• Patients on warfarin (>2mg) for thrombosis must be able and willing to switch to low molecular weight heparin prior to registration for protocol therapy.
• No use of drugs having proarrhythmic potential (terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide) within 7 days prior to registration for protocol therapy.
• No use of CYP3A4 inhibitors (see section 5.3 for a list) within 7 days of registration for protocol therapy.
• No use of CYP3A4 inducers (see section 5.3 for a list) within 14 days of registration for protocol therapy.
• No use of amiodarone (CYP3A4 inhibitor) within 6 months of registration for protocol therapy.
• Females must not be breastfeeding.

Where it is running

• University of Florida — Gainesville, Florida, United States
• Indiana University Simon Cancer Center — Indianapolis, Indiana, United States
• Northern Indiana Cancer Research Consortium — South Bend, Indiana, United States
• Baylor College of Medicine — Houston, Texas, United States
• St. Bartholomew's Hospital (Barts) — London, United Kingdom

Full record on ClinicalTrials.gov

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