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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan Cancer Center; University of Michigan Rogel Cancer Center
• Collaborators: Bristol-Myers Squibb; Eli Lilly and Company; ImClone LLC; National Comprehensive Cancer Network
• Treatments: Cetuximab; Cisplatin; Gemcitabine

Criteria

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.