Clinical Trial Details

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Study ID NCI-2011-01952
Investigator
Jonathan Rosenberg,   Cancer and Leukemia Group B
Title Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer
Conditions Distal Urethral Cancer
Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
Proximal Urethral Cancer
Recurrent Bladder Cancer
Recurrent Prostate Cancer
Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
Recurrent Urethral Cancer
Stage IV Bladder Cancer
Stage IV Prostate Cancer
Transitional Cell Carcinoma of the Bladder
Urethral Cancer Associated With Invasive Bladder Cancer
Interventions Drug: gemcitabine hydrochloride
Drug: cisplatin
Other: placebo
Biological: bevacizumab
Other: laboratory biomarker analysis
Phase Phase 3
Purpose This randomized phase III trial is studying gemcitabine hydrochloride, cisplatin, and bevacizumab to see how well they work compared with gemcitabine hydrochloride, cisplatin, and placebo in treating patients with advanced urinary tract cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether gemcitabine hydrochloride and cisplatin are more effective when given together with or without bevacizumab in treating patients with urinary tract cancer.
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Both
Accepts Healthy Volunteers:  No
Inclusion Criteria:
  • Patients must have histologically or cytologically documented metastatic or unresectable transitional cell (urothelial) carcinoma of the urinary tract (renal pelvis, ureter, bladder, prostate, or urethra), with metastatic or locally advanced disease (T4b, N2, N3, or M1); patients must not be candidates for potentially curative surgery or radiotherapy
  • Patients may not have received prior combination systemic chemotherapy for metastatic disease - For the purposes of this study, radiosensitizing single-agent chemotherapy is not considered prior systemic therapy - Prior neoadjuvant or adjuvant systemic chemotherapy is permissible provided it was completed >= 1 year prior to the diagnosis of metastatic disease
  • At least 4 weeks since prior radiation (including palliative) or major surgery and fully recovered
  • At least 7 days since any minor surgery such as port placement
  • At least 4 weeks since any intravesical therapy
  • No prior treatment with bevacizumab or other angiogenesis inhibitors
  • No known history of brain metastases; brain imaging (magnetic resonance imaging [MRI]/computed tomography [CT]) is not required
  • No current congestive heart failure; New York Heart Association (NYHA) class II, III or IV
  • Patients with history of hypertension must be well controlled (< 150/90) on a regimen of anti-hypertensive therapy
  • Patients on full-dose anticoagulants must be on a stable dose of warfarin and have an in-range international normalized ratio (INR) (usually between 2 and 3) or be on a stable dose of low molecular weight (LMW) heparin; patients receiving anti-platelet agents are also eligible; in addition, patients who are on daily prophylactic aspirin or anticoagulation for atrial fibrillation are eligible
  • No significant history of bleeding events or gastrointestinal (GI) perforation - Patients with a history of a significant bleeding episode (e.g. hemoptysis, upper or lower GI bleeding, grade 3 or 4 gross hematuria unable to be controlled by trans-urethral resection of the bladder tumor) within 6 months of registration are not eligible - Patients with a history of GI perforation within 12 months of registration are not eligible - Patients with a history of peritoneal carcinomatosis are not eligible
  • No arterial thrombotic events within 6 months of registration, including transient ischemic attack (TIA), cerebrovascular accident (CVA), peripheral arterial thrombus, unstable angina or angina requiring surgical or medical intervention in the past 6 months, or myocardial infarction (MI); patients with clinically significant peripheral artery disease (i.e., claudication on less than one block) are ineligible
  • Patients who have experienced a deep venous thrombosis or pulmonary embolus within the past 6 months must be on stable therapeutic anticoagulation to be enrolled to this study
  • No serious or non-healing wound, ulcer, or bone fracture
  • No sensory or motor peripheral neuropathy >= grade 2
  • Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies are not eligible
  • Patients that are pregnant or nursing are not eligible; women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to registration - For women of child-bearing potential with an elevated beta-HCG that is believed to be related to cancer and not pregnancy, a negative trans-vaginal ultrasound and gynecological examination are required - Women of child-bearing potential include any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea >= 12 consecutive months; or women on hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level > 35mIU/mL); even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 OR Karnofsky PS >= 80
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Calculated or measured creatinine clearance >= 50 mL/minute
  • Bilirubin =< 1.25 times upper limit of normal (ULN) (for patients with Gilbert's Disease, =< 2.5 X ULN is allowed)
  • Aspartate aminotransferase (AST) =< 2.0 times ULN
  • Urine protein to creatinine ratio < 1.0 OR urine protein =< 1+ OR 24-hour urine protein =< 1 gram
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Contact Carla I. Falkson
205-934-0309
Information objtained from ClinicalTrials.gov, on 8/2/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00942331


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