Paclitaxel-binding Albumin and Cisplatin as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2020

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Treatment plan
    • Paclitaxel-binding albumin 260 mg/m2,d1,ivgtt;cisplatin 75 mg/m2,d1,ivgtt

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • The Pathologic Response Rate (<pT2) of Neoadjuvant Paclitaxel-binding albumin and Cisplatin in Patients With Muscle-invasive Bladder Cancer.
    • Time Frame: 2 years
    • is defined as the absence of muscle invasive carcinoma (<pT2 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen

Participating in This Clinical Trial

Inclusion Criteria

1. Age ≥ 18 years. 2. 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. 3. There was at least one measurable tumor lesion following RECIST 1.1. 4. Treatment naïve. 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 6. Left ventricular ejection fraction≥50%. 7. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L,platelets (PLT) ≥ 100 × 109/L,hemoglobin (Hb) ≥ 90 g/L,leucocyte ≥ 3.0 × 109/L. 8. 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. 9. Signed informed content obtained prior to treatment. Exclusion Criteria:

1. Patients who are pregnant or may be pregnant or nursing. 2. Patients with Coagulation dysfunction or active internal hemorrhage. 3. Patients with uncontrolled active infection,HIV,viral hepatitis. 4. Peripheral nerve lesion≥grade 1 following NCI-CTC 5.0. 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. 6. History of allergic reactions attributed to compounds of similar chemical or biological composition to drugs used in this study. 7. Patients was involved in another study within the last 30 days. 8. Patients was mental disorders. 9. Any other patients deemed by the attending physician to be unsuitable to allow the feasible for this study.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Third Military Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dong Wang, chief physician – Third Military Medical University
  • Overall Official(s)
    • Dong Wang, Principal Investigator, Daping Hospital, Third Military Medical University, Chongqing,China
  • Overall Contact(s)
    • Dong Wang, PH.D, 86-23-68757181, dongwang64@hotmail.com

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