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

NCT04060459 | Unknown Phase 2 DMC

• 1 other identifier: ThirdMMUa
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

Bladder cancer；Paclitaxel-binding albumin；Cisplatin；Neoadjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  2 years

Study Arms (1)

Treatment plan

EXPERIMENTAL

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

Drug: Paclitaxel-binding albumin

Interventions

Paclitaxel-binding albumin DRUG

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

Treatment plan

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 1.1.
• Treatment naïve.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• 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.

You may not qualify if:

• 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 5.0.
• 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.

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Dong Wang

  Daping Hospital, Third Military Medical University, Chongqing,China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Wang, PH.D

CONTACT

86-23-68757181; dongwang64@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 19, 2019
• Study Start: October 1, 2018
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2022
• Last Updated: August 19, 2019

Record last verified: 2018-10

Locations

CN (1)