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Therapeutic Areas: Nephrology | Oncology | Family Medicine
Disease Category: Genitourinary Cancer
Location: United States, IL

Clinical Trial Details

Overview

Research Study Summary

CTSU-CALGB 90601 Phase III Randomized Study of Gemcitabine Hydrochloride and Cisplatin With Versus Without Bevacizumab in Patients With Advanced Transitional Cell Carcinoma of the Urinary Tract

Purpose

Compare the overall survival of patients with advanced transitional cell carcinoma of the urinary tract treated with gemcitabine hydrochloride, cisplatin, and bevacizumab vs gemcitabine hydrochloride, cisplatin, and placebo.

Patient Inclusion Criteria:

  • Histologically or cytologically confirmed transitional (urothelial) cell carcinoma of the urinary tract (renal pelvis, ureter, bladder, prostate, or urethra)
  • Unresectable metastatic or locally advanced disease (T4b, N2, N3, or M1)
  • Not a candidate for potentially curative surgery or radiotherapy
  • No history of peritoneal carcinomatosis
  • No known brain metastases

Patient Exclusion Criteria:

  • At least 4 weeks since prior intravesical therapy
  • At least 7 days since any minor surgery such as port placement
  • No prior combination systemic chemotherapy for metastatic disease
  • Single-agent radiosensitizing chemotherapy is not considered prior systemic therapy
  • Prior neoadjuvant or adjuvant systemic chemotherapy allowed provided it was completed = 1 year prior to the diagnosis of metastatic disease
  • No prior bevacizumab or other angiogenesis inhibitors

To Learn more
Phase

3

Gender

Both Male and Female

Age

N/A

Overall Status

Recruiting

Facility Type

N/A

Contact

Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
Sherman Health
1425 North Randall Road
Elgin, IL 60123
Phone: 224-783-2907
Fax: 224-783-3071

View Map

Research Center Information: Sherman Health

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 183109

Date Last Changed: July 17, 2013


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