Clinical Trial NU MS11U01
- Phase II Trial of Everolimus or Everolimus plus Paclitaxel as First-line Therapy in Cisplatin-ineligible Patients with Advanced Urothelial Carcinoma (GU10-147)
- Principal Investigator
- Timothy Kuzel
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.NU MS11U01
- The purpose of this research study is to see the safety and effectiveness of Everolimus when given alone or when given in combination with Paclitaxel.
- Participants in this study have transitional cell carcinoma (TCC). TCC is a type of cancer that is usually from the bladder, but can also be from organs associated with the bladder, such as the ureters (tubes connecting the bladder with thekidneys). An investigational drug called Everolimus, also known as RAD001, will be evaluated when used either alone or with another drug called Paclitaxel as a possible treatment for TCC. Experiments have shown that Everolimus can prevent cancer cells from multiplying, so Everolimus is being tested in medical conditions to stop cancer cells from multiplying too much. Paclitaxel is the standard treatment that is routinely given to patients with TCC. Investigational means the U.S. Food and Drug Administration (FDA) has not approved the drug for use in this type of cancer.
Some of the eligibility criteria include:
- Participants must be at least 18 years old.
- Participants must be diagnosed with transitional cell carcinoma (TCC) of the bladder, urethra, ureter, or renal pelvis.
- Participants must not have received any prior chemotherapy for metastatic disease.
- Description of Treatment
- Participants in cohort 1 of this study will take Everolimus daily. The cycle length will last 28 days. Everolimus will be dispensed on Day 1 of each cycle. A diary will be provided where participants will have to record daily intake of pills. Participants will continue to take Everolimus until the disease worsens or they experience an unacceptable toxicity, death or discontinue treatment for any other reason. Participants in cohort 2 of this study will receive Everolimus as described above, along with Paclitaxel. Paclitaxel will be given intravenously (into the veins), over one hour on days 1,8 and 15 of a 28-day cycle. Participants will be in the study until unacceptable toxicities, disease progression, or Physician’s decision to withdraw them from study.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 14-Feb-16 06:38 AM
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