NCT01215136

First-line Everolimus +/- Paclitaxel for Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Matthew Galsky · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Transitional Cell Carcinoma
• Bladder Carcinoma
• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Everolimus	10 mg PO daily (continuously, without scheduled treatment interruptions). The cycle length will last 28 days. Everolimus will be dispensed on Day 1 of each cycle by the study center personnel on an outpatient basis.
DRUG	Everolimus	10 mg PO daily (continuously, without scheduled treatment interruptions). The cycle length will last 28 days. Everolimus will be dispensed on Day 1 of each cycle by the study center personnel on an outpatient basis.
DRUG	Paclitaxel	Paclitaxel 80 mg/m2 IV as a 1 hour infusion on days 1, 8, and 15, of a 28-day cycle.

Timeline

• Start date: 2010-12-01
• Primary completion: 2017-04-24
• Completion: 2018-04-24
• First posted: 2010-10-06
• Last updated: 2023-11-24
• Results posted: 2023-11-24

Locations

11 sites across 1 country: United States