Status and phase
Conditions
Treatments
About
Background:
Advanced urothelial cancer has no cure. But only a few chemotherapy drugs have been tested for it. The Co-eXpression ExtrapolatioN (COXEN) model predicts if cells respond to treatment. It may also help determine which drugs fight urothelial cancer based on the characteristics of a tumor. Researchers want to test if this model can choose the best therapy for advanced urothelial cancer within 3 weeks and how tumors respond to the next best therapy.
Objective:
To test if the COXEN model can choose the best therapy for advanced urothelial cancer within 3 weeks.
Eligibility:
People ages 18 and older whose urothelial cancer has spread after at least 1 line of chemotherapy
Design:
Participants will be screened with medical history, physical exam, blood and urine tests, and tumor scans.
Participants will provide a tumor sample from a previous surgery and a new biopsy. A needle will remove a small piece of tumor.
Participants will repeat screening tests, plus have an electrocardiogram (EKG) and scan. For the scan, they will get an injection of radioactive drug. They will lie in a machine that takes pictures.
Participants will take the drugs assigned by the COXEN model. They will have visits every 2-3 weeks. These will include blood and urine tests.
Participants will have tumor scans every 8-9 weeks.
Participants may have another biopsy.
Participants will take the drugs until they can't tolerate the side effects or their cancer worsens. They may be assigned to a second COXEN therapy.
Participants will have a follow-up visit 4-5 weeks after their last drug dose.
Participants will be contacted by phone every few months until death.
Full description
Background:
Objectives:
Eligibility:
Patients must have a histologically confirmed diagnosis of metastatic, progressive urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
Patients must have progressive metastatic disease defined as new or progressive lesions on cross-sectional imaging.
Patients must have at least:
Patients must have been previously treated, as defined by treatment with at least one prior cytotoxic chemotherapy regimen or agent. Patients may have received any number of prior cytotoxic agents.
Archival tumor tissue must be available for enrollment.
Tumor amenable to biopsy will be mandatory for this study.
18 years of age or older
Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >60%)
Design:
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
INCLUSION CRITERIA:
Patients must have a histologically confirmed diagnosis of metastatic, progressive urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
Patients must have progressive metastatic disease defined as new or progressive lesions on cross-sectional imaging.
Patients must have at least:
Patients must have been previously treated with at least one prior cytotoxic chemotherapy regimen or agent. Patients may have received any number of prior cytotoxic agents.
Archival tumor tissue must be available for enrollment.
Tumor amenable to biopsy will be mandatory for this study.
Age more than or equal to 18 years. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky more than or equal to 60%,).
Patients must have normal organ and marrow function as defined below:
OR
--creatinine clearance more than or equal to 40 mL/min/1.73 m^2
EXCLUSION CRITERIA:
Primary purpose
Allocation
Interventional model
Masking
8 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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