First-line Everolimus +/- Paclitaxel for Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01215136|
Recruitment Status : Active, not recruiting
First Posted : October 6, 2010
Last Update Posted : April 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Transitional Cell Carcinoma Bladder Carcinoma Urothelial Carcinoma||Drug: Everolimus Drug: Paclitaxel||Phase 2|
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
- 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
- Bilirubin ≤ 1.5 x ULN
- Aminotransferases (AST and ALT) ≤ 2.5 x ULN (unless liver metastases, then ≤ 5 x ULN)
- Calculated creatinine clearance of < 60 using the Cockcroft-Gault formula
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||December 2010|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Active Comparator: Cohort 1
Single-agent everolimus (enrollment limited to patients with patients with creatinine clearance < 60 ml/min AND Karnofsky performance status of 60-70%)
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.
Active Comparator: Cohort 2
Everolimus plus paclitaxel (enrollment limited to patients with creatinine clearance < 60 ml/min OR Karnofsky performance status of 60-70%)
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.
- Response Rate [ Time Frame: 4 months ]To evaluate clinical benefit rate (complete response, partial response, and stable disease) at 4 months from initiation of treatment.
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 4 months ]To determine the safety of everolimus and everolimus plus paclitaxel in this patient population.
- Progression Free Survival [ Time Frame: 4 months ]To determine progression free survival
- Survival - 1 year [ Time Frame: 12 months ]To determine survival at 1-year from the initiation of treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01215136
|United States, Alabama|
|University of Alabama Hematology Oncology Clinic at Medical West|
|Birmingham, Alabama, United States, 35294|
|United States, Illinois|
|Northwestern University, Robert H. Lurie Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60611|
|United States, Indiana|
|Cancer Care Center of Southern Indiana|
|Bloomington, Indiana, United States, 47403|
|Indiana University Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|IU Health Central Indiana Cancer Centers|
|Indianapolis, Indiana, United States, 46219|
|United States, Michigan|
|Metro Health Cancer Care|
|Wyoming, Michigan, United States, 49519|
|United States, Nebraska|
|Nebraska Cancer Specialists|
|Omaha, Nebraska, United States, 68114|
|United States, New York|
|Icahn School of Medicine: Tisch Cancer Institute at Mount Sinai Medical Center|
|New York, New York, United States, 10029|
|United States, South Carolina|
|MUSC Hollings Cancer Center|
|Charleston, South Carolina, United States, 29425|
|United States, Texas|
|University of Texas Medical Branch|
|Galveston, Texas, United States, 77555|
|United States, Virginia|
|Virginia Oncology Associates|
|Norfolk, Virginia, United States, 23502|
|Study Chair:||Matthew Galsky, M.D.||Hoosier Cancer Research Network|