Paclitaxel-binding Albumin and Cisplatin as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer - A Single-center, Single-arm and Stage II Clinical Study

Third Military Medical University1 site in 1 country50 target enrollmentOctober 1, 2018

ConditionsBladder Cancer

InterventionsPaclitaxel-binding albumin

DrugsPaclitaxel-binding albumin

Overview

Phase: Phase 2
Intervention: Paclitaxel-binding albumin
Conditions: Bladder Cancer
Sponsor: Third Military Medical University
Enrollment: 50
Locations: 1
Primary Endpoint: The Pathologic Complete Response Rate (<pT0) of Neoadjuvant Paclitaxel-binding albumin and Cisplatin in Patients With Muscle-invasive Bladder Cancer.
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase II study of Paclitaxel-binding albumin, Cisplatin as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.

Registry

clinicaltrials.gov

Start Date

October 1, 2018

End Date

October 2022

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Third Military Medical University

Responsible Party

Principal Investigator

Dong Wang

chief physician

Third Military Medical University

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years.
•Patients must have histologically confirmed resectable（stage T2，T3 and T4a） urothelial carcinoma following 2017 V8 AJCC，including renal pelvic carcinoma，ureteral carcinoma，bladder carcinoma and urethral carcinoma.
•There was at least one measurable tumor lesion following RECIST 1.
•Treatment naïve.
•Eastern Cooperative Oncology Group (ECOG) performance status 0-
•Left ventricular ejection fraction≥50%.
•Absolute neutrophil count (ANC) ≥ 1.5 × 109/L，platelets (PLT) ≥ 100 × 109/L，hemoglobin (Hb) ≥ 90 g/L，leucocyte ≥ 3.0 × 109/L.
•Total bilirubin (TBIL) ≤ 1.5 ×institutional upper limit of normal (ULN)， Alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) /Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]≤ 2.5 ×ULN ，Creatinine (CRE) ≤ 1.5 ×ULN.
•Signed informed content obtained prior to treatment.

Exclusion Criteria

•Patients who are pregnant or may be pregnant or nursing.
•Patients with Coagulation dysfunction or active internal hemorrhage.
•Patients with uncontrolled active infection，HIV，viral hepatitis.
•Peripheral nerve lesion≥grade 1 following NCI-CTC 5.
•Patients with serious cardiovasculardisease including history of cerebral vascular accident ， myocardial infarction，hypertension，angina，heart failure（NYHA grade 2-4） within the last 6 months.
•History of allergic reactions attributed to compounds of similar chemical or biological composition to drugs used in this study.
•Patients was involved in another study within the last 30 days.
•Patients was mental disorders.
•Any other patients deemed by the attending physician to be unsuitable to allow the feasible for this study.

Arms & Interventions

Treatment plan

Paclitaxel-binding albumin 260 mg/m2，d1，ivgtt；cisplatin 75 mg/m2，d1，ivgtt

Intervention: Paclitaxel-binding albumin

Outcomes

Primary Outcomes

The Pathologic Complete Response Rate (<pT0) of Neoadjuvant Paclitaxel-binding albumin and Cisplatin in Patients With Muscle-invasive Bladder Cancer.

Time Frame: 2 years

Complete pathologic response to neoadjuvant GCS is the primary endpoint is defined as the absence of carcinoma (pT0 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.