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

Not Recruiting

Trial ID: NCT00645593


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.

Official Title

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

Stanford Investigator(s)

Sandy Srinivas
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology


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.


drug: Gemcitabine,

drug: Cisplatin

drug: Cetuximab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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