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

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Trial Conditions
  • Distal Urethral Cancer
  • Bladder Cancer
  • Prostate Cancer
  • Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Proximal Urethral Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Urethral Cancer
  • Recurrent Bladder Cancer
  • Recurrent Prostate Cancer
  • Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Recurrent Urethral Cancer
  • Regional Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Stage IV Bladder Cancer
  • Stage IV Prostate Cancer
  • Stage IV Urethral Cancer
  • Transitional Cell Carcinoma of the Bladder
  • Ureter Cancer
  • Urethral Cancer Associated With Invasive Bladder Cancer
What is the purpose of this trial?

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 together with or without bevacizumab in treating patients with urinary tract cancer.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

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 the
interval from end of therapy to diagnosis of metastatic disease is at least 1 year

- >= 4 weeks since 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 >
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 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

Gender: Both
Steward Physician(s)
  • Jonathan Rosenberg
Facilities
  • St. Elizabeth's Medical Center - Recruiting
Trial Interventions
Biological
  • bevacizumab
Drug
  • gemcitabine hydrochloride
  • cisplatin
Other
  • placebo
  • laboratory biomarker analysis
For more information about this trial, contact

Leslie A. Martin

Phone: (617) 789-2903


Physician Researcher

Investigator Name:

  • Jonathan Rosenberg

Other Information

Sponsor: National Cancer Institute (NCI)
Phase: Phase 3
Trial ID: NCT00942331
Volunteers:  Not Accepting Healthy Volunteers

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