Transitional Cell Carcinoma of the Bladder Clinical Trial
Official title:
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
Verified date | August 2015 |
Source | Hoosier Cancer Research Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 9 |
Est. completion date | April 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | St. Bartholomew's Hospital (Barts) | London | |
United States | University of Florida | Gainesville | Florida |
United States | Baylor College of Medicine | Houston | Texas |
United States | Indiana University Simon Cancer Center | Indianapolis | Indiana |
United States | Northern Indiana Cancer Research Consortium | South Bend | Indiana |
Lead Sponsor | Collaborator |
---|---|
Noah Hahn, M.D. | Hoosier Cancer Research Network, Pfizer |
United States, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the pathological complete response rate. | 18 months | No | |
Secondary | To evaluate the safety profile of sunitinib malate in combination with cisplatin and gemcitabine followed by radical cystectomy. | 18 months | Yes | |
Secondary | To determine the objective response rate for patients with measurable disease according to RECIST. | 18 months | No | |
Secondary | To determine progression free survival. | 18 months | No | |
Secondary | To evaluate the impact of sunitinib malate in combination with cisplatin and gemcitabine on expression of selected biomarkers. | 18 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02897765 -
A Personal Cancer Vaccine (NEO-PV-01) w/ Nivolumab for Patients With Melanoma, Lung Cancer or Bladder Cancer
|
Phase 1 | |
Terminated |
NCT01118351 -
Sunitinib Malate in Treating Patients With Recurrent Transitional Cell Bladder Cancer
|
Phase 2 | |
Terminated |
NCT00112905 -
Sorafenib in Treating Patients With Regional or Metastatic Cancer of the Urothelium
|
Phase 2 | |
Completed |
NCT00072150 -
Phase II Trial Of PS-341 (Bortezomib) In Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma
|
Phase 2 | |
Completed |
NCT00028756 -
Comparison of Immediate and Delayed Adjuvant Chemotherapy in Treating Patients Who Have Undergone a Radical Cystectomy for Stage III or Stage IV Transitional Cell Carcinoma of the Bladder Urothelium
|
Phase 3 | |
Completed |
NCT02318329 -
Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT00407485 -
VEGF Trap in Treating Patients With Recurrent, Locally Advanced, or Metastatic Cancer of the Urothelium
|
Phase 2 | |
Withdrawn |
NCT01639521 -
Gemcitabine Hydrochloride and Cisplatin or High-Dose Methotrexate, Vinblastine, Doxorubicin Hydrochloride, and Cisplatin in Treating Patients With Urothelial Cancer
|
Phase 2 | |
Completed |
NCT00003167 -
Gene Therapy in Treating Patients With Advanced Bladder Cancer
|
Phase 1 | |
Completed |
NCT03081858 -
Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT02101931 -
A Laser Detection for Bladder Cancer by (Photodynamic) Spectra of Urine
|
Phase 3 | |
Completed |
NCT00005831 -
Trastuzumab and Combination Chemotherapy in Treating Patients With Locally Recurrent or Metastatic Urinary Tract Cancer
|
Phase 2 | |
Completed |
NCT00706641 -
Neoadjuvant Dasatinib and Radical Cystectomy for Transitional Cell Carcinoma of the Bladder
|
N/A | |
Completed |
NCT01824329 -
Prostate Capsule Sparing Cystectomy and Nerve-sparing Radical Cystoprostatectomy in Men With Bladder Cancer
|
Phase 2 | |
Terminated |
NCT00363883 -
Vorinostat in Treating Patients With Locally Recurrent or Metastatic Cancer of the Urothelium
|
Phase 2 | |
Completed |
NCT00021099 -
Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer
|
Phase 2 | |
Terminated |
NCT01382706 -
Docetaxel and Lapatinib in Metastatic Transitional Cell Carcinoma in Bladder
|
Phase 2 | |
Terminated |
NCT01954173 -
Adjuvant Radiation for High Risk Bladder Cancer
|
N/A | |
Terminated |
NCT00004856 -
Trastuzumab in Treating Patients With Previously Treated, Locally Advanced, or Metastatic Cancer of the Urothelium
|
Phase 2 | |
Terminated |
NCT01282333 -
Veliparib, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Advanced Biliary, Pancreatic, Urothelial, or Non-Small Cell Lung Cancer
|
Phase 1 |