ABOUT THIS STUDY
- 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.
- 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
- 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
- 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
- Females must not be breastfeeding.
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