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Phase II Randomized Trial of Gemcitabine and Cisplatin With or Without Cetuximab in Patients With Urothelial Carcinoma

Phase 2
18 Years
Open (Enrolling)
Bladder Cancer

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Trial Information

Phase II Randomized Trial of Gemcitabine and Cisplatin With or Without Cetuximab in Patients With Urothelial Carcinoma

Urothelial cancer typically begins in the lining of the bladder, the balloon-shaped organ in
the pelvic area that stores urine. Urothelial cancer can also begin in the ureter (the tube
connecting the kidney and bladder), part of the kidney itself, or the urethra (the tube you
pass urine out of). Some Urothelial cancers remain confined to the lining, while in other
cases they spread to other areas. Treatment for these cancers varies greatly depending on
the stage of disease at the time of diagnosis. Study participants in this research study
will have a diagnosis of urothelial cancer that is advanced or has come back after prior

There are two standard chemotherapeutic regimens for the management of this disease. One is
the combination of the drugs, methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC).
However the toxicities associated with this treatment regimen (side effects) is high.

The other is a combination of two drugs called Cisplatin and Gemcitabine. These drugs are
also known to destroy urothelial cancer cells, and are better tolerated by patients. All
study participants will receive both of these drugs.

Another anti-cancer drug called Cetuximab is known to delay or prevent tumor growth and in
some cases to lead to death of cancer cells by blocking certain cellular pathways that lead
to tumor development. This drug has been approved by the United States Food and Drug
Administration (FDA) for the treatment of colorectal cancer and for treatment of head and
neck cancers. The use of Cetuximab for the treatment of urothelial cancer is investigational
in this study.

The purpose of this study is to compare the safety and efficacy of Gemcitabine and Cisplatin
administered with or without the addition of Cetuximab in study participants with urothelial

This is a randomized research study. Study participants will be randomized to receive either
gemcitabine and cisplatin alone or in combination with Cetuximab.

Inclusion Criteria:

- Study participants will be male or female at least 18 years of age

- Study participants will have a histologic/cytologic diagnosis of urothelial carcinoma
(transitional cell carcinoma; either pure or mixed histology) that is metastatic,
locally recurrent, or unresectable (T4bN0 or any T, N2030)

- Study participants must have measurable disease by radiologic imaging. Study
participants that have received previous radiation therapy, recovered from side
effects and have not had more than 25% of the bone marrow

- Study participants must have adequate bone marrow function

Exclusion Criteria:

- Study participants may not have received previous systemic chemotherapy for the
current stage of disease with the following exception: prior neoadjuvant or adjuvant
chemotherapy is allowed provided it has been at least 6 months since treatment with
non-cisplatin containing regimens and > 1 year since treatment with a cisplatin
containing regimen

- Study participants may not have received prior therapy targeting the EGFR pathway

- Study participants may not have a history or known spinal cord compression, or
carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease
on screening CT or MRI scan

- Study participants may not have known HIV due to the intense nature of the
chemotherapy in this trial

- Study subjects may not have a history of congestive heart failure (CHF), chronic
renal failure, active TIAs, recent (in the last 6 months) stroke, symptomatic
pulmonary embolism (PE), or myocardial infarction.

- Study participants with history of DVT or incidental or asymptomatic PE will be
eligible for the study as deemed appropriate by the treating physician provided they
continue prophylactic or full dose anticoagulation as per standards of care for the
specific event.

- Study participants must not have a prior grade 3 or 4 severe infusion reaction to
monoclonal antibodies

- Study participants may not be pregnant or breastfeeding

- Study participants may not receive concurrent treatment on another therapeutic
clinical trial.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To compare the overall response rate of combination gemcitabine and cisplatin with or without cetuximab in patients with locally advanced or metastatic urothelial carcinoma

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Maha Hussain, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan


United States: Institutional Review Board

Study ID:

UMCC 2007.097



Start Date:

March 2008

Completion Date:

June 2015

Related Keywords:

  • Bladder Cancer
  • Bladder Cancer
  • Urinary Bladder Neoplasms



University of Michigan Ann Arbor, Michigan  48109-0624
Roswell Park Cancer Institute Buffalo, New York  14263
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Stanford University Stanford, California  94305
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Boston Medical Center Boston, Massachusetts  02118
University of Washington Seattle, Washington  98195
Lahey Clinic Burlington, Massachusetts  01805
University of Texas MD Anderson Cancer Center Houston, Texas  77030
University of Utah Huntsman Cancer Institute Salt Lake City, Utah  84112
City of Hope Cancer Center Duarte, California  91010
Kenneth J. Norris Jr. Comprehensive Cancer Center, Keck School of Medicine, University of Southern California Los Angeles, California  90033
Robert H. Lurie Comprehensive Cancer Center, Center of Northwestern University Chicago, Illinois  60611
Wayne State University/Karmanos Cancer Institute Detroit, Michigan  48201