Back to resultsA Trial of Paclitaxel (Albumin-binding) for Castration-resistant Prostate Cancer
Primary Purpose
Castration-resistant Prostate Cancer
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
nab-paclitaxel
carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Castration-resistant Prostate Cancer focused on measuring castration-resistant prostate cancer, paclitaxel (albumin-binding), carboplatin
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years, Male;
- diagnosed as prostate cancer by histopathology or cytology;
- Confirmed as castration-resistant prostate cancer: 1 interval 1 week, 3 consecutive PSA minimum values increased by >50%; 2 serum testosterones <50ng/dl or <1.7nmol/L [Guide of the Chinese Urological Association (2015) The diagnostic criteria of CRPC];
- There are no other concurrent anti-cancer treatments (including local radiotherapy, systemic chemotherapy, and molecular targeted therapy) or previous treatment history;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- The estimated survival period is more than 3 months;
- having at least one measurable lesion according to the RECIST 1.1 tumor evaluation criteria;
- No obvious signs of hematological disease, ANC≥1.5×109/L, platelet count≥100×109/L, Hb≥90g/L, WBC≥3.0×109/L, and no bleeding tendency before enrollment;
- Liver function test: total bilirubin (TBIL) ≤1.5 times the upper limit of normal value, alanine aminotransferase (ALT), aspartate aminotransferase (AST) are ≤2.5 times the upper limit of normal value, if due to liver metastasis, the above indicators ≤5 times the upper limit of normal value; renal function test: serum creatinine (Cr) ≤ 1.5mg/dl, or calculated creatinine clearance rate ≥50ml/min;
- Understand the circumstances of this study, patients and/or legal representatives voluntarily agree to participate in the trial and sign informed consent.
Exclusion Criteria:
• Have a birth plan during the clinical trial;
- Patients with brain metastases;
- Severe cardiovascular diseases such as cerebrovascular accidents occurring within 6 months, myocardial infarction, hypertension that cannot be controlled after drug intervention, unstable angina pectoris, heart failure (NYHA 2-4), and arrhythmia requiring drugs Intervention;
- Dementia, mental state changes or any mental illness that may interfere with understanding or making informed consent or completing a questionnaire;
- Subjects with ≥1 peripheral neuropathy according to CTCAE V version 4.03;
- Allergy or hypersensitivity history of the drug or drug ingredient used in this test;
- Excluding other malignant tumors, cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or any other part of the carcinoma in situ;
- Have received any other test drug treatment or participated in another interventional clinical trial within 30 days of the screening period;
- The investigator believes that it is not suitable for inclusion.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
nab-paclitaxel + Carboplatin
Arm Description
nab-paclitaxel at 260 mg/m^2 on days 1; Carboplatin AUG=5, d1, 21 days in one cycle, 3 cycles in total
Outcomes
Primary Outcome Measures
Prostate specific antigen (PSA)
PSA was effective: PSA decreased by ≥ 50% for more than 4 weeks, and there was no evidence of clinical and imaging progression; PSA progression: PSA increased more than 25% of baseline or baseline during chemotherapy, and the absolute value was ≥ 5 ng/ml.
Secondary Outcome Measures
ORR
Objective Response Rate
TTF
Time to treatment failure
OS
Overall survival
Full Information
NCT ID
NCT04148885
First Posted
October 29, 2019
Last Updated
October 30, 2019
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04148885
Brief Title
A Trial of Paclitaxel (Albumin-binding) for Castration-resistant Prostate Cancer
Official Title
One-arm, Multi-center Clinical Trial of Paclitaxel (Albumin-binding) Combined With Carboplatin for Castration-resistant Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2019 (Anticipated)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
One-arm, multi-center clinical trial of paclitaxel (albumin-binding) combined with carboplatin for castration-resistant prostate cancer
Detailed Description
Prostate cancer is one of the most common malignant tumors of the male genitourinary system. In 2017, the American Oncology Society will report that 161,360 new prostate cancers were estimated, accounting for 21% of male tumors, ranking first in male new tumors; 26,730 death, cancer death. The rate is second only to bronchial lung cancer and colorectal cancer. In China, although the incidence of prostate cancer is lower than the world epidemiological level, the incidence of prostate cancer in China has shown an increasing trend in recent years. The latest statistics from the National Cancer Center 2017, the incidence of male prostate cancer is 2.4%, which is a male malignant tumor. Seventh place in the disease. The taxane drug docetaxel showed good anti-tumor activity in castration resistant prostate cancer (CRPC) patients, and paclitaxel combined with carboplatin also had a certain effect on CRPC. However, in clinical practice, patients with prostate cancer are mostly old, often accompanied by other underlying diseases, poor physical status, and poor tolerance in the use of docetaxel and paclitaxel. Albumin-bound paclitaxel has more tumor-targeted enrichment than traditional paclitaxel and is less toxic. Therefore, this study intends to explore the efficacy and safety of albumin-bound paclitaxel combined with carboplatin in the treatment of CRPC, providing a reference for the treatment options of CRPC in clinical practice.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Castration-resistant Prostate Cancer
Keywords
castration-resistant prostate cancer, paclitaxel (albumin-binding), carboplatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nab-paclitaxel + Carboplatin
Arm Type
Experimental
Arm Description
nab-paclitaxel at 260 mg/m^2 on days 1; Carboplatin AUG=5, d1, 21 days in one cycle, 3 cycles in total
Intervention Type
Drug
Intervention Name(s)
nab-paclitaxel
Other Intervention Name(s)
Abraxane
Intervention Description
Patients firstly receive nab-paclitaxel 100 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
carboplatin
Other Intervention Name(s)
Paraplatin, Carboplat, Ercar
Intervention Description
Patients secondly receive carboplatin AUC=5 (iv, 30 minutes) on days 1 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.
Primary Outcome Measure Information:
Title
Prostate specific antigen (PSA)
Description
PSA was effective: PSA decreased by ≥ 50% for more than 4 weeks, and there was no evidence of clinical and imaging progression; PSA progression: PSA increased more than 25% of baseline or baseline during chemotherapy, and the absolute value was ≥ 5 ng/ml.
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Secondary Outcome Measure Information:
Title
ORR
Description
Objective Response Rate
Time Frame
From date of enrollment (after curative resection) until the date of death from any cause, assessed one month during therapy and 3 months thereafter
Title
TTF
Description
Time to treatment failure
Time Frame
From date of enrollment (after curative resection) until the date of death from any cause, assessed one month during therapy and 3 months thereafter
Title
OS
Description
Overall survival
Time Frame
From date of enrollment (after curative resection) until the date of death from any cause, assessed one month during therapy and 3 months thereafter
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years, Male;
diagnosed as prostate cancer by histopathology or cytology;
Confirmed as castration-resistant prostate cancer: 1 interval 1 week, 3 consecutive PSA minimum values increased by >50%; 2 serum testosterones <50ng/dl or <1.7nmol/L [Guide of the Chinese Urological Association (2015) The diagnostic criteria of CRPC];
There are no other concurrent anti-cancer treatments (including local radiotherapy, systemic chemotherapy, and molecular targeted therapy) or previous treatment history;
Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
The estimated survival period is more than 3 months;
having at least one measurable lesion according to the RECIST 1.1 tumor evaluation criteria;
No obvious signs of hematological disease, ANC≥1.5×109/L, platelet count≥100×109/L, Hb≥90g/L, WBC≥3.0×109/L, and no bleeding tendency before enrollment;
Liver function test: total bilirubin (TBIL) ≤1.5 times the upper limit of normal value, alanine aminotransferase (ALT), aspartate aminotransferase (AST) are ≤2.5 times the upper limit of normal value, if due to liver metastasis, the above indicators ≤5 times the upper limit of normal value; renal function test: serum creatinine (Cr) ≤ 1.5mg/dl, or calculated creatinine clearance rate ≥50ml/min;
Understand the circumstances of this study, patients and/or legal representatives voluntarily agree to participate in the trial and sign informed consent.
Exclusion Criteria:
• Have a birth plan during the clinical trial;
Patients with brain metastases;
Severe cardiovascular diseases such as cerebrovascular accidents occurring within 6 months, myocardial infarction, hypertension that cannot be controlled after drug intervention, unstable angina pectoris, heart failure (NYHA 2-4), and arrhythmia requiring drugs Intervention;
Dementia, mental state changes or any mental illness that may interfere with understanding or making informed consent or completing a questionnaire;
Subjects with ≥1 peripheral neuropathy according to CTCAE V version 4.03;
Allergy or hypersensitivity history of the drug or drug ingredient used in this test;
Excluding other malignant tumors, cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or any other part of the carcinoma in situ;
Have received any other test drug treatment or participated in another interventional clinical trial within 30 days of the screening period;
The investigator believes that it is not suitable for inclusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Qi, MD PHD
Phone
+8618121288167
Email
Leeqi2001@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
A Trial of Paclitaxel (Albumin-binding) for Castration-resistant Prostate Cancer
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