Cancer Clinical Trial
Official title:
Phase II Trial of Gemcitabine, Carboplatin, and Bevacizumab in Chemotherapy Naive Patients With Advanced/Metastatic Urothelial Carcinoma
Gemcitabine and carboplatin are two standard chemotherapy drugs used to treat tumors of the
urothelial tract. These drugs do not shrink tumors in all patients and when they do, it is
generally for a limited amount of time. This has led scientists to look for different ways
to treat cancer.
New drugs have been developed to treat cancer that work differently than standard
chemotherapy drugs. One new class of drugs are called 'angiogenesis-inhibitors'. These drugs
attempt to decrease the blood supply to tumors. By doing so, this may limit the tumor's
source of oxygen and nutrients and prevent the tumor from growing. Bevacizumab is an
anti-angiogenic drug.
In some other cancers such as colon cancer and lung cancer, combining bevacizumab with
standard chemotherapy shrinks tumors in a greater proportion of patients and makes patients
live longer than using standard chemotherapy alone. This has never been tested in urothelial
cancer and we do not know if bevacizumab will have the same effects in this disease. The
purpose of this study is to find out what effects, good and/or bad, the combination of
gemcitabine, carboplatin, and bevacizumab has on you and your cancer.
Status | Completed |
Enrollment | 51 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologic documentation: diagnosis of transitional cell carcinoma of the bladder,urethra, ureter, or renal pelvis. - Unresectable or metastatic disease - Ineligible for cisplatin (or incurable with cisplatin) - = 4 weeks since prior RT - Karnofsky Performance Status = 60% - Age = 18 years of age - Required Initial Laboratory Values: Absolute neutrophil count = 1.2 x 109/L; Platelets = 100 x 109/L; Bilirubin = 1.5 times the upper limit of normal (x ULN) for the institution; Aspartate transaminase (AST) and alanine transaminase(ALT) = 3.0 x ULN;Serum creatinine < 2.0 or calculated creatinine clearance (CrCl) = 30 mL/min Exclusion Criteria: - Prior treatment with systemic chemotherapy (prior intravesical therapy is permitted) - Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study - Blood pressure of >150/100 mmHg - Unstable angina - New York Heart Association (NYHA) Grade II or greater congestive heart failure - History of myocardial infarction within 6 months - History of stroke within 6 months - Clinically significant peripheral vascular disease - Evidence of bleeding diathesis or coagulopathy - Presence of central nervous system or brain metastases - Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0 - Anticipation of need for major surgical procedure during the course of the study - Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0 - Pregnant (positive pregnancy test) or lactating - Albuminuria as demonstrated by a urinary albumin of greater or = to 1.0 g/24 hr at screening - 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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Memoral Sloan Kettering Cancer Center | Basking Ridge | New Jersey |
United States | Memorial Sloan-Kettering at Basking Ridge | Basking Ridge | New Jersey |
United States | Memorial Sloan-Kettering Cancer Center @ Suffolk | Commack | New York |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | Memorial Sloan-Kettering Cancer Center at Mercy Medical Center | Rockville Centre | New York |
United States | Memoral Sloan Kettering Cancer Center@Phelps | Sleepy Hollow | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the Time to Disease Progression | Response and progression will be evaluated in this study using the international criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI, 92(3):205-216, 2000]. Changes in only the largest diameter (uni-dimensional measurement) are used in the RECIST criteria. | 3 years | Yes |
Secondary | The Response Rate of Combination Therapy With Bevacizumab, Gemcitabine, and Carboplatin in Patients With Advanced/Metastatic TCC. | 3 years | No |
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