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

NCT04148885 | Unknown Phase 1

• 1 other identifier: CSPC-KAL-PC-01
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Castration-resistant Prostate Cancer

Keywords

castration-resistant prostate cancer; paclitaxel (albumin-binding); carboplatin

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (3)

• ORR

  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

  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

  From date of enrollment (after curative resection) until the date of death from any cause, assessed one month during therapy and 3 months thereafter

Study Arms (1)

nab-paclitaxel + Carboplatin

EXPERIMENTAL

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; Drug: carboplatin

Interventions

nab-paclitaxel DRUG

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.

Also known as: Abraxane

nab-paclitaxel + Carboplatin

carboplatin DRUG

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.

Also known as: Paraplatin, Carboplat, Ercar

nab-paclitaxel + Carboplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Carboplatin

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Coordination Complexes

Central Study Contacts

Li Qi, MD PHD

CONTACT

+8618121288167; Leeqi2001@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive director of cancer center

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 4, 2019
• Study Start: November 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 4, 2019

Record last verified: 2019-10