Spots Global Cancer Trial Database for First-line Everolimus +/- Paclitaxel for Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma
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Trial Identification
Brief Title: First-line Everolimus +/- Paclitaxel for Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma
Official Title: Phase II Trial of Everolimus or Everolimus Plus Paclitaxel as First-line Therapy in Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma: Hoosier Cancer Research Network GU10-147
Study ID: NCT01215136
Study Description
Brief Summary: The purpose of this trial is to explore the activity and safety of everolimus +/- paclitaxel as first-line therapy for cisplatin-ineligible patients with advanced urothelial carcinoma.
Detailed Description: OUTLINE: This is a multi-center study Patients will be enrolled into one of two parallel cohorts: * Cohort 1: impaired renal function AND poor performance status (cycle length = 28 days). Everolimus 10 mg orally daily * Cohort 2: impaired renal function OR poor performance status (cycle length = 28 days). Everolimus 10 mg orally daily + IV Paclitaxel 80 mg/m2 on D1, 8, 15 Restaging evaluations will be performed after every 2 cycles. Treatment will continue until disease progression or unacceptable toxicity. Karnofsky performance status 60-70% Life Expectancy: Not specified Hematopoietic: * Absolute neutrophil count (ANC) ≥ 1.5 K/mm3 * Hemoglobin (Hgb) ≥ 9 g/dL * Platelets ≥ 100 K/mm3 * INR ≤ 1.5 (Anticoagulants are allowed if target INR ≤ 1.5 on a stable dose of warfarin or on a stable dose of Low molecular weight (LMW) heparin for at least 2 weeks prior to registration for protocol therapy). * Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L * Fasting triglycerides ≤ 2.5 x ULN. * Fasting serum glucose \< 1.5 x ULN Hepatic: * Bilirubin ≤ 1.5 x ULN * Aminotransferases (AST and ALT) ≤ 2.5 x ULN (unless liver metastases, then ≤ 5 x ULN) Renal: * Calculated creatinine clearance of \< 60 using the Cockcroft-Gault formula Cardiovascular: * No symptomatic congestive heart failure of New York heart Association Class III or IV. * No unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama Hematology Oncology Clinic at Medical West, Birmingham, Alabama, United States
Northwestern University, Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois, United States
Cancer Care Center of Southern Indiana, Bloomington, Indiana, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
IU Health Central Indiana Cancer Centers, Indianapolis, Indiana, United States
Metro Health Cancer Care, Wyoming, Michigan, United States
Nebraska Cancer Specialists, Omaha, Nebraska, United States
Icahn School of Medicine: Tisch Cancer Institute at Mount Sinai Medical Center, New York, New York, United States
MUSC Hollings Cancer Center, Charleston, South Carolina, United States
University of Texas Medical Branch, Galveston, Texas, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Contact Details
Name: Matthew Galsky, M.D.
Affiliation: Hoosier Cancer Research Network
Role: STUDY_CHAIR
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