Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer

Not Recruiting

Trial ID: NCT00942331


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. Immunotherapy with bevacizumab, may induce changes in body's immune system and 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

Stanford Investigator(s)

Sandy Srinivas
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology


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

      - 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

      - >= 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

   - 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


drug: cisplatin

drug: gemcitabine hydrochloride

biological: bevacizumab

other: laboratory biomarker analysis

other: Placebo Administration

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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