Study of Gemcitabine and Cisplatin With or Without Cetuximab in Urothelial Cancer

Completed · Phase 2

Conditions studied: Bladder Cancer

In brief

This study will compare the effects, good and/or bad, of chemotherapy (Gemcitabine and Cisplatin) with or without the addition of the chemotherapy drug Cetuximab to find out which treatment is better.

Key facts

Study ID

NCT00645593

Run by

University of Michigan Rogel Cancer Center

People needed

89

Starts

2008-03-01

Expected to finish

2015-06-01

Last updated by the study team

2016-05-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• City of Hope Cancer Center — Duarte, California, United States
• Kenneth J. Norris Jr. Comprehensive Cancer Center, Keck School of Medicine, University of Southern California — Los Angeles, California, United States
• Stanford University — Stanford, California, United States
• Robert H. Lurie Comprehensive Cancer Center, Center of Northwestern University — Chicago, Illinois, United States
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Wayne State University/Karmanos Cancer Institute — Detroit, Michigan, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• University of Utah Huntsman Cancer Institute — Salt Lake City, Utah, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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