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

Primary Purpose

Bladder Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Paclitaxel-binding albumin
Sponsored by
Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Bladder cancer；Paclitaxel-binding albumin；Cisplatin；Neoadjuvant Chemotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Daping Hospital, Third Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment plan

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 15, 2019
Last Updated
August 15, 2019
Sponsor
Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04060459
Brief Title
Paclitaxel-binding Albumin and Cisplatin as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Military Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Bladder cancer；Paclitaxel-binding albumin；Cisplatin；Neoadjuvant Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment plan
Arm Type
Experimental
Arm Description
Paclitaxel-binding albumin 260 mg/m2，d1，ivgtt；cisplatin 75 mg/m2，d1，ivgtt
Intervention Type
Drug
Intervention Name(s)
Paclitaxel-binding albumin
Intervention Description
Paclitaxel-binding albumin 260 mg/m2，d1，ivgtt；cisplatin 75 mg/m2，d1，ivgtt
Primary Outcome Measure Information:
Title
The Pathologic Complete Response Rate (<pT0) of Neoadjuvant Paclitaxel-binding albumin and Cisplatin in Patients With Muscle-invasive Bladder Cancer.
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The Pathologic Response Rate (<pT2) of Neoadjuvant Paclitaxel-binding albumin and Cisplatin in Patients With Muscle-invasive Bladder Cancer.
Description
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
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Wang, PH.D
Phone
86-23-68757181
Email
dongwang64@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Wang
Organizational Affiliation
Daping Hospital, Third Military Medical University, Chongqing,China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daping Hospital, Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Wang, PH.D.
Phone
86-23-68757151
Email
dongwang64@hotmail.com
First Name & Middle Initial & Last Name & Degree
Dong Wang, PH.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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