A Trial of Paclitaxel (Albumin-binding) for Castration-resistant Prostate Cancer

October 30, 2019 updated by: Qi Li, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

One-arm, Multi-center Clinical Trial of Paclitaxel (Albumin-binding) Combined With Carboplatin for Castration-resistant Prostate Cancer

One-arm, multi-center clinical trial of paclitaxel (albumin-binding) combined with carboplatin for castration-resistant prostate cancer

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nab-paclitaxel + Carboplatin
nab-paclitaxel at 260 mg/m^2 on days 1; Carboplatin AUG=5, d1, 21 days in one cycle, 3 cycles in total
Drug: nab-paclitaxel
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.
Other Names:
  • Abraxane
Drug: carboplatin
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.
Other Names:
  • Carboplat
  • Ercar
  • Paraplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prostate specific antigen (PSA)
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
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
ORR
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
Objective Response Rate
From date of enrollment (after curative resection) until the date of death from any cause, assessed one month during therapy and 3 months thereafter
TTF
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
Time to treatment failure
From date of enrollment (after curative resection) until the date of death from any cause, assessed one month during therapy and 3 months thereafter
OS
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
Overall survival
From date of enrollment (after curative resection) until the date of death from any cause, assessed one month during therapy and 3 months thereafter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2019

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

October 29, 2019

First Submitted That Met QC Criteria

October 30, 2019

First Posted (Actual)

November 4, 2019

Study Record Updates

Last Update Posted (Actual)

November 4, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPC-KAL-PC-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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