Status:
COMPLETED
Study of Gemcitabine and Cisplatin With or Without Cetuximab in Urothelial Cancer
Lead Sponsor:
University of Michigan Rogel Cancer Center
Collaborating Sponsors:
National Comprehensive Cancer Network
Bristol-Myers Squibb
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00645593
Start Date
March 1 2008
End Date
June 1 2015
Last Update
May 23 2016
Active Locations (14)
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1
City of Hope Cancer Center
Duarte, California, United States, 91010
2
Kenneth J. Norris Jr. Comprehensive Cancer Center, Keck School of Medicine, University of Southern California
Los Angeles, California, United States, 90033
3
Stanford University
Stanford, California, United States, 94305
4
Robert H. Lurie Comprehensive Cancer Center, Center of Northwestern University
Chicago, Illinois, United States, 60611