Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy for TCC
NCT00859339
ABOUT THIS STUDY
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- 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
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.
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Descriptive Information | ||||
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Brief Title ICMJE | Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy for TCC | |||
Official Title ICMJE | A Phase II Trial of Neoadjuvant Cisplatin, Gemcitabine and Sunitinib Malate Followed by Radical Cystectomy for Transitional Cell Carcinoma (TCC) of the Bladder: Hoosier Oncology Group GU07-123 | |||
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.
The treatment regimen will be administered in four, 21-day, cycles followed by radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate. ECOG performance status 0 or 1 Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Transitional Cell Carcinoma of the Bladder | |||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Experimental Treatment
Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy Interventions:
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Publications * | Galsky MD, Hahn NM, Powles T, Hellerstedt BA, Lerner SP, Gardner TA, Yu M, O'Rourke M, Vogelzang NJ, Kocs D, McKenney SA, Melnyk AM Jr, Hutson TE, Rauch M, Wang Y, Asmar L, Sonpavde G. Gemcitabine, Cisplatin, and sunitinib for metastatic urothelial carcinoma and as preoperative therapy for muscle-invasive bladder cancer. Clin Genitourin Cancer. 2013 Jun;11(2):175-81. doi: 10.1016/j.clgc.2012.10.001. Epub 2012 Dec 8. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 9 | |||
Original Estimated Enrollment ICMJE | 46 | |||
Actual Study Completion Date ICMJE | April 2011 | |||
Actual Primary Completion Date | April 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00859339 | |||
Other Study ID Numbers ICMJE | HOG GU07-123 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Responsible Party | Noah Hahn, M.D., Hoosier Cancer Research Network | |||
Study Sponsor ICMJE | Noah Hahn, M.D. | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Hoosier Cancer Research Network | |||
Verification Date | March 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |