Bladder Cancer Clinical Trial
Official title:
Phase II Randomized Trial of Gemcitabine and Cisplatin With or Without Cetuximab in Patients With Urothelial Carcinoma
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.
Status | Completed |
Enrollment | 89 |
Est. completion date | June 2015 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
United States | Boston Medical Center | Boston | Massachusetts |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Lahey Clinic | Burlington | Massachusetts |
United States | Robert H. Lurie Comprehensive Cancer Center, Center of Northwestern University | Chicago | Illinois |
United States | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan |
United States | City of Hope Cancer Center | Duarte | California |
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
United States | Kenneth J. Norris Jr. Comprehensive Cancer Center, Keck School of Medicine, University of Southern California | Los Angeles | California |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | University of Utah Huntsman Cancer Institute | Salt Lake City | Utah |
United States | University of Washington | Seattle | Washington |
United States | Stanford University | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
University of Michigan Cancer Center | Bristol-Myers Squibb, ImClone LLC, National Comprehensive Cancer Network |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants That Respond to Treatment in Arm 1 and Arm 2 | The primary objective is to compare the overall response rate of participants with locally advanced or metastatic urothelial carcinoma treated with gemcitabine and cisplatin with or without cetuximab. Overall response rate is defined as the percentage of participants that experience Complete Response (CR) (Disappearance of all target lesions) or Partial Response (PR) (>=30% decrease in the sum of the longest diameter of target lesions). |
3 years | No |
Secondary | The Number of Grade 3 to 5 Adverse Events Experienced by Arm 1 and Arm 2 | One of the secondary outcomes was to assess the safety and tolerability of treatment for both arms. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 were utilized for adverse event reporting. |
3 years | Yes |
Secondary | Median Progression-free Survival Time in Months | Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions. | 3 years | No |
Secondary | Median Overall Survival in Months | Median overall survival in months is provided. One participant who progressed from chemotherapy in arm 1 received cyclophosphamide and achieved long-term disease control therefore there is no upper limit for the 95% confidence interval. | 3 years | No |
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