Trial of Gemcitabine, Carboplatin, and Sorafenib in Chemotherapy-naive Patients With Advanced/Metastatic Bladder Carcinoma
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hari Deshpande, Yale University
First received: April 16, 2007
Last updated: June 22, 2014
Last verified: June 2014
This is a Phase II, nonrandomized multicenter study designed to evaluate time to progression and response proportion of patients with advanced or metastatic transitional cell carcinoma of bladder receiving 6 cycles of gemcitabine, carboplatin and sorafenib and then maintenance sorafenib.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase II, Multicenter Trial of Gemcitabine, Carboplatin, and Sorafenib in Chemotherapy-naive Patients With Advanced/Metastatic Bladder Carcinoma
Primary Outcome Measures:
- To evaluate the time to disease progression in patients with advanced/metastatic TCC treated with the combination of sorafenib, gemcitabine, and carboplatin. [ Time Frame: Upon completion of study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To determine the overall safety and tolerability of combination therapy with sorafenib, gemcitabine and carboplatin [ Time Frame: Upon completion of study ] [ Designated as safety issue: Yes ]
- To define the proportion of patients with advanced or metastatic transitional cell carcinoma of the bladder that achieve a complete or partial response to the combination therapy with sorafenib, gemcitabine, and carboplatin. [ Time Frame: Upon completion of study ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||February 2015 (Final data collection date for primary outcome measure)
Experimental: Chemotherapy plus sorafenib
Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone
Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.
Other Name: Gemzar
Carboplatin will be given on day 1 to an AUC of 5.
Sorafenib will be administered orally daily on days 2-19 at 400 mg bid
Other Name: BAY 43-9006
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Prior treatment with systemic chemotherapy (prior intravesical chemotherapy is permitted, and adjuvant therapy is permitted if > 12 months have lapsed)
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
- Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
- History of stroke within six months
- Clinically significant peripheral vascular disease
- Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
- Sorafenib is contraindicated in patients with known severe hypersensitivity to sorafenib or any of the excipients.
- Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
- Active clinically serious infection > CTCAE Grade 2.
- Thrombolytic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
- Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of study drug
- Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of study drug
- Evidence or history of bleeding diathesis or coagulopathy
- Major surgery, significant traumatic injury within 4 weeks of first study drug
- Use of St. John's Wort or rifampin (rifampicin)
- Known or suspected allergy to sorafenib or any agent given in the course of this trial
- Any condition that impairs patient's ability to swallow whole pills
- Any malabsorption problem
- Anticipation of need for major surgical procedure during the course of the study
- Pregnant (positive pregnancy test) or lactating
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
- Serious, non-healing wound, ulcer, or bone fracture
- Inability to comply with study and/or follow-up procedures
- History of persistent gross hematuria
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00461851
|Yale University, Comprehensive Cancer Center
|New Haven, Connecticut, United States, 06520 |
||Hari Deshpande, MD
No publications provided
||Hari Deshpande, Assistant Professor of Medicine, Yale University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 16, 2007
||June 22, 2014
||United States: Institutional Review Board
Keywords provided by Yale University:
Advanced/Metastatic Bladder Carcinoma
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 23, 2015
Urinary Bladder Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protein Kinase Inhibitors