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

Urothelial Carcinoma Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Bladder Carcinoma
• Carcinoma
• Carcinoma, Transitional Cell
• Transitional Cell Carcinoma
• Urinary Bladder Neoplasms
• Urothelial Carcinoma

• NCT number: NCT01215136
• Study type: Interventional
• Source: Hoosier Cancer Research Network
• Status: Terminated
• Phase: Phase 2
• Start date: December 2010
• Completion date: April 24, 2018