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Summary

for people ages 18 years and up (full criteria)
at Fresno, California and other locations
study started

Description

Summary

This randomized phase III trial studies gemcitabine hydrochloride, cisplatin, and bevacizumab to see how well they work compared with gemcitabine hydrochloride and cisplatin in treating patients with urinary tract cancer that has spread to other places in the body. 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, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether gemcitabine hydrochloride and cisplatin are more effective when given with or without bevacizumab in treating patients with urinary tract cancer.

Official Title

A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients With Advanced Transitional Cell Carcinoma

Details

PRIMARY OBJECTIVES:

  1. To determine if patients with advanced transitional cell carcinoma treated with bevacizumab, gemcitabine (gemcitabine hydrochloride) and cisplatin will have increased overall survival when compared to patients treated with gemcitabine, cisplatin, and placebo.

SECONDARY OBJECTIVES:

  1. To compare the progression-free survival of these two regimens in patients with advanced transitional cell carcinoma.

II. To compare the proportion of patients who experience an objective response on each regimen.

III. To compare the grade 3 and greater toxicities in patients treated on the two regimens.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, cisplatin IV, and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically for up to 7 years.

Keywords

Bladder Urothelial Carcinoma Distal Urethral Carcinoma Infiltrating Bladder Urothelial Carcinoma Associated With Urethral Carcinoma Metastatic Urothelial Carcinoma of the Renal Pelvis and Ureter Proximal Urethral Carcinoma Recurrent Bladder Carcinoma Recurrent Prostate Carcinoma Recurrent Urethra Carcinoma Recurrent Urothelial Carcinoma of the Renal Pelvis and Ureter Regional Urothelial Carcinoma of the Renal Pelvis and Ureter Stage IV Bladder Cancer Stage IV Prostate Cancer Stage IV Urethral Cancer Ureter Carcinoma Carcinoma Urinary Bladder Neoplasms Carcinoma, Transitional Cell Prostatic Neoplasms Urethral Neoplasms Kidney Neoplasms Ureteral Neoplasms Gemcitabine Cisplatin Bevacizumab Antibodies Immunoglobulins Antibodies, Monoclonal Immunoglobulin G Endothelial Growth Factors

Eligibility

For people ages 18 years and up

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
  • For patients that have had surgical resection prior to study enrollment, residual or unresected disease (measurable and/or unmeasurable) must be evident on post-surgical scans
  • Prior treatment for transitional cell carcinoma (TCC)
  • Patients may not have received 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 the interval from end of therapy to diagnosis of metastatic disease is at least 1 year
  • >= 4 weeks since any prior radiation (including palliative) or major surgery and fully recovered
  • >= 7 days since any minor surgery such as port placement
  • >= 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 > 35 mIU/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 0-1 (or Karnofsky performance status [KPS] >= 80)
  • Absolute neutrophil count (ANC) >= 1,500/uL
  • Platelet count >= 100,000/uL
  • Calculated or measured creatinine clearance >= 50 mL/minute
  • Bilirubin =< 1.25 times upper limits of normal; for patients with Gilbert's disease,=< 2.5 x upper limit of normal (ULN) is allowed
  • Aspartate aminotransferase (AST) =< 2.0 x upper limits of normal
  • Urine protein to creatinine ratio < 1.0 or urine protein =< 1+ or 24-hour urine protein =< 1 gram

Locations

  • California Cancer Center - North Fresno
    Fresno, California, 93720, United States
  • California Pacific Medical Center-Pacific Campus
    San Francisco, California, 94115, United States
  • UCSF Medical Center-Mount Zion
    San Francisco, California, 94115, United States
  • Bay Area Breast Surgeons Inc
    Emeryville, California, 94608, United States
  • Epic Care Partners in Cancer Care
    Emeryville, California, 94608, United States
  • Alta Bates Summit Medical Center - Summit Campus
    Oakland, California, 94609, United States
  • Bay Area Tumor Institute
    Oakland, California, 94609, United States
  • Hematology and Oncology Associates-Oakland
    Oakland, California, 94609, United States
  • Tom K Lee Inc
    Oakland, California, 94609, United States
  • Alta Bates Summit Medical Center-Herrick Campus
    Berkeley, California, 94704, United States
  • Marin Cancer Care Inc
    Greenbrae, California, 94904, United States
  • Marin General Hospital
    Greenbrae, California, 94904, United States
  • Highland General Hospital
    Oakland, California, 94602, United States
  • Mills-Peninsula Medical Center
    Burlingame, California, 94010, United States
  • Doctors Medical Center- JC Robinson Regional Cancer Center
    San Pablo, California, 94806, United States
  • East Bay Radiation Oncology Center
    Castro Valley, California, 94546, United States
  • Valley Medical Oncology Consultants-Castro Valley
    Castro Valley, California, 94546, United States
  • Contra Costa Regional Medical Center
    Martinez, California, 94553-3156, United States
  • Sutter Cancer Research Consortium
    Novato, California, 94945, United States
  • Palo Alto Medical Foundation Health Care
    Palo Alto, California, 94301, United States
  • Stanford Cancer Institute Palo Alto
    Palo Alto, California, 94304, United States
  • Sutter Solano Medical Center/Cancer Center
    Vallejo, California, 94589, United States
  • Valley Medical Oncology Consultants-Fremont
    Fremont, California, 94538, United States
  • Valley Care Health System - Pleasanton
    Pleasanton, California, 94588, United States
  • Valley Medical Oncology Consultants
    Pleasanton, California, 94588, United States
  • El Camino Hospital
    Mountain View, California, 94040, United States
  • Palo Alto Medical Foundation-Camino Division
    Mountain View, California, 94040, United States
  • Palo Alto Medical Foundation-Sunnyvale
    Sunnyvale, California, 94086, United States
  • Saint Helena Hospital
    Saint Helena, California, 94574, United States
  • Sutter Pacific Medical Foundation
    Santa Rosa, California, 95403, United States
  • Palo Alto Medical Foundation-Santa Cruz
    Santa Cruz, California, 95065, United States
  • Memorial Medical Center
    Modesto, California, 95355, United States
  • Northridge Hospital Medical Center
    Northridge, California, 91325, United States
  • Keck Medical Center of USC Pasadena
    Pasadena, California, 91105, United States
  • Los Angeles County-USC Medical Center
    Los Angeles, California, 90033, United States
  • USC / Norris Comprehensive Cancer Center
    Los Angeles, California, 90033, United States
  • Saint Joseph Hospital - Orange
    Orange, California, 92868, United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center
    Orange, California, 92868, United States
  • Comprehensive Cancer Centers of Nevada-Summerlin
    Las Vegas, Nevada, 89144, United States
  • Summerlin Hospital Medical Center
    Las Vegas, Nevada, 89144, United States
  • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
    Las Vegas, Nevada, 89149, United States
  • Cancer and Blood Specialists-Tenaya
    Las Vegas, Nevada, 89128, United States
  • Comprehensive Cancer Centers of Nevada - Northwest
    Las Vegas, Nevada, 89128, United States
  • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
    Las Vegas, Nevada, 89128, United States
  • Las Vegas Cancer Center-Medical Center
    Las Vegas, Nevada, 89148-2405, United States
  • 21st Century Oncology - Fort Apache
    Las Vegas, Nevada, 89148, United States
  • Comprehensive Cancer Centers of Nevada
    Las Vegas, Nevada, 89148, United States
  • Nevada Cancer Specialists-Fort Apache
    Las Vegas, Nevada, 89148, United States
  • HealthCare Partners Medical Group Oncology/Hematology-San Martin
    Las Vegas, Nevada, 89113, United States
  • University Medical Center of Southern Nevada
    Las Vegas, Nevada, 89102, United States
  • Cancer and Blood Specialists-Shadow
    Las Vegas, Nevada, 89106, United States
  • Nevada Cancer Research Foundation CCOP
    Las Vegas, Nevada, 89106, United States
  • Radiation Oncology Centers of Nevada Central
    Las Vegas, Nevada, 89106, United States
  • 21st Century Oncology - Vegas Tenaya
    Las Vegas, Nevada, 89182, United States
  • 21st Century Oncology
    Las Vegas, Nevada, 89109, United States
  • Children's Specialty Center of Nevada II
    Las Vegas, Nevada, 89109, United States
  • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
    Las Vegas, Nevada, 89109, United States
  • Comprehensive Cancer Centers of Nevada - Central Valley
    Las Vegas, Nevada, 89169, United States
  • Radiation Oncology Centers of Nevada Southeast
    Las Vegas, Nevada, 89119, United States
  • Cancer and Blood Specialists-Henderson
    Henderson, Nevada, 89052, United States
  • Comprehensive Cancer Centers of Nevada - Henderson
    Henderson, Nevada, 89052, United States
  • Las Vegas Cancer Center-Henderson
    Henderson, Nevada, 89052, United States
  • Cancer Therapy and Integrative Medicine
    Las Vegas, Nevada, 89121, United States
  • 21st Century Oncology - Henderson
    Henderson, Nevada, 89074, United States
  • Comprehensive Cancer Centers of Nevada-Southeast Henderson
    Henderson, Nevada, 89074, United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
National Cancer Institute (NCI)
ID
NCT00942331
Phase
Phase 3
Lead Scientist
Study Type
Interventional
Last Updated
October 16, 2017