A Phase 0 Clinical Trial of Microdosing Carboplatin and Molecular Profiling for Chemoresistance
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Correlation of carboplatin-DNA monoadducts induced by microdoses of carboplatin with cancer response to carboplatin-based chemotherapy
Imaging studies (including CT, MRI, PET/CT and CXR) and cystoscopy will be performed to evaluate the response. The RECIST 1.1 will be used to determine the cancer response. Tumor response, including complete response (CR, or complete disappearance) or partial response (PR, at least a 30% decrease of target lesion) will be correlated with the patient's carboplatin-DNA monoadduct levels.
Patients will be evaluated for response to chemotherapy after they have received 2 to 3 cycles of chemo that is about 6-9 weeks after treatment is started.
Chong-xian Pan, MD, PhD
University of California, Davis
United States: Food and Drug Administration
|University of California, Davis||Sacramento, California 95818|