Study of Gemcitabine and Cisplatin With or Without Cetuximab in Urothelial Cancer
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Intervention: Gemcitabine,; Cisplatin; Cetuximab
Intervention description: Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.; Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle.; Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
Intervention MeSH terms: Gemcitabine; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bladder Cancer

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.
    

Eligibility 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.