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

Phase 2

• Conditions: Bladder Cancer
• Interventions: Drug: Paclitaxel-binding albumin

• Registration Number: NCT04060459
• Lead Sponsor: Third Military Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-10
• Study Start: 2018-10-01
• Study First Submitted: 2019-08-15
• Study First Submitted QC: 2019-08-15
• Last Update Submitted: 2019-08-15
• Study First Posted: 2019-08-19
• Last Update Posted: 2019-08-19
• Primary Completion: 2020-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment plan	Paclitaxel-binding albumin	Paclitaxel-binding albumin 260 mg/m2，d1，ivgtt；cisplatin 75 mg/m2，d1，ivgtt

Primary Outcome Measures

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

Name	Time	Method
The Pathologic Response Rate (<pT2) of Neoadjuvant Paclitaxel-binding albumin and Cisplatin in Patients With Muscle-invasive Bladder Cancer.	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

Trial Locations

Locations (1)

Daping Hospital, Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China