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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04060459
• Other study ID #: ThirdMMUa
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2018
• Est. completion date: October 2022

Study information

• Verified date: October 2018
• Source: Third Military Medical University
• Contact: Dong Wang, PH.D
• Phone: 86-23-68757181
• Email: dongwang64[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2022
• Est. primary completion date: October 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Daping Hospital, Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 (	2 years