operable bladder cancer (T2 to T4a) lymph node negative disease
Conditions
Interventions
Trade Name: GEMZAR
Product Name: gemzar
Pharmaceutical Form: Powder for solution for infusion
Trade Name: Cisplatin
Product Name: cisplatin
Pharmaceutical Form: Sterile concentrate*
Trade Name: SUTE
Sponsors
Hoosier Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Written informed consent for release of personal health information. •Age > 18 years at the time of consent. •ECOG Performance Status of 0-1 within 14 days prior to registration for protocol therapy. •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. NOTE: Subjects are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. •Females must not be breastfeeding. •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. •No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason 1.5 K/mm3 [International Sites (IS): 1.5 x 109/L]. • Platelets > 100 K/mm3 [IS: 100 x 109/L]. • Hemoglobin (Hgb) > 9.0 g/dL [IS: 90 g/L]. • 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 prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Any prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason 150/100 mm Hg despite optimal medical therapy). • Evidence of ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade 2. • History of uncontrolled/untreated thyroid dysfunction. • Prolonged QTc interval (>450 msec) on preentry electrocardiogram obtained within 28 days prior to registration for protocol therapy. • 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. • Use of CYP3A4 inhibitors within 7 days of registration for protocol therapy (ketoconazole, itraconazole, voriconazole, fluconazole, troleandomycin, clarithromycin, erythromycin, diltiazem, verapamil, delavirdine, amprenavir, lopinivir, indinavir, saquinavir, ritonavir, nelfinavir, nefazodone, fluvoxamine, cimetidine, aprepitant). • Use of CYP3A4 inducers within 14 days of registration for protocol therapy (rifampicin, rifabutin, rifapentine, carbamazepine, phenobarbital, phenytoin, St John’s Wort, modafinil, efavirenz, nevirapine, cortisone (>50 mg), hydrocortisone (>40mg), prednisone (>10 mg), methylprednisolone (>8 mg), dexamethasone (>1.5 mg)2). • Use of amiodarone (CYP3A4 inhibitor) within 6 months of registration for protocol therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: To determine the pathological complete response rate at cystectomy after four cycles of neoadjuvent Gemcitabine/Cisplatin/Sunitinib therapy in operable bladder cancer. ;Primary end point(s): Primary Endpoint: To determine the pathological complete response rate associated with neoadjuvent Gemcitibine, cisplatin and sunitinib therapy. This will be assessed at the time of cystectomy. ;Secondary Objective: Secondary Objective: •To evaluate the safety profile of sunitinib malate in combination with cisplatin and gemcitabine followed by radical cystectomy. •To determine the objective response rate for patients with measurable disease according to RECIST. •To determine progression free survival. •To evaluate the impact of sunitinib malate in combination with cisplatin and gemcitabine on expression of selected biomarkers. | — |
Countries
United Kingdom
Outcome results
None listed