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

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

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.

Study Overview

• Status: Unknown
• Conditions: Bladder Cancer
• Intervention / Treatment: Drug: Paclitaxel-binding albumin

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Recruiting
      • Daping Hospital, Third Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment plan; Paclitaxel-binding albumin 260 mg/m2，d1，ivgtt；cisplatin 75 mg/m2，d1，ivgtt	Drug: Paclitaxel-binding albumin; Paclitaxel-binding albumin 260 mg/m2，d1，ivgtt；cisplatin 75 mg/m2，d1，ivgtt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Pathologic Complete Response Rate (<pT0) of Neoadjuvant Paclitaxel-binding albumin and Cisplatin in Patients With Muscle-invasive Bladder Cancer.	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Pathologic Response Rate (<pT2) of Neoadjuvant Paclitaxel-binding albumin and Cisplatin in Patients With Muscle-invasive Bladder Cancer.	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	2 years

Collaborators and Investigators

• Sponsor: Third Military Medical University
• Investigators: Principal Investigator: Dong Wang, Daping Hospital, Third Military Medical University, Chongqing,China

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: August 15, 2019
• First Submitted That Met QC Criteria: August 15, 2019
• First Posted (Actual): August 19, 2019

Study Record Updates

• Last Update Posted (Actual): August 19, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Bladder cancer；Paclitaxel-binding albumin；Cisplatin；Neoadjuvant Chemotherapy
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: ThirdMMUa

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No