Status:
TERMINATED
Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy for TCC
Lead Sponsor:
Noah Hahn, M.D.
Collaborating Sponsors:
Pfizer
Hoosier Cancer Research Network
Conditions:
Transitional Cell Carcinoma of the Bladder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
OUTLINE: This is a multi-center study. * Gemcitabine ( 1000 mg/m2) IV days 1 and 8 * Cisplatin (70 mg/m2) IV day 1 and * Sunitinib malate (37.5 mg) oral daily for days 1-14 The treatment regimen wil...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00859339
Start Date
March 1 2009
End Date
April 1 2011
Last Update
April 14 2016
Active Locations (5)
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1
University of Florida
Gainesville, Florida, United States, 32610
2
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
3
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601
4
Baylor College of Medicine
Houston, Texas, United States, 77030