Lauren Harshman
Randomized Study of Gemcitabine and Cisplatin With or Without Cetuximab in Urothelial Cancer
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
This study will compare 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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Gemcitabine, Cisplatin
- Drug: Gemcitabine, Cisplatin and Cetuximab
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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
Key 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 regiments 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, or prior grade 3 or 4 severe infusion reaction to monoclonal antibodies
- Study participants may not be pregnant or breastfeeding
Additional Study Details
Official Title:
Phase II Randomized Trial fo Gemcitabine and Cisplatin With or Without Cetuximab in Patients With Urothelial CarcinomaAnticipated start date:
6/3/2008Lead Sponsor:
ImClone Systems IncorporatedCollaborator(s):
- NCCN - National Comprehensive Cancer Network
- Bristol Myers-Squibb
- University of Michigan
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
OpenControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- To compare the overall response rate of combination gemcitabine and cisplatin with or without cetuximab in patients with locally advanced or metastatic urothelial carcinoma
Secondary Outcomes:
- To assess the safety and tolerability, response duration, the progression-free survival and overall survival of both treatment groups, and whether cetuximab will sensitize non-responding patients to combination gemcitabine and cisplatin
Total Number to be Enrolled:
81Total Number to be Enrolled at Stanford:
10More Information
Secondary ID(s):
- 98789
- BLDR0008
- NCT00645593
- UMCC 2007.097
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
9/9/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
Help