Metastatic Hormone-Sensitive Prostate CancerPhase 1/2NCT03343977
Toxicity & Pharmacokinetics of 2 & 3-weekly Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
A Phase 1/2 study testing docetaxel 50mg/m2 and docetaxel 75mg/m2 in people with Metastatic Hormone-Sensitive Prostate Cancer, run by Peng Wang, MD PhD at 1 site in United States.
Trial summary
This study is designed to investigate the toxicity and pharmacokinetics (PK) of 2-weekly and 3-weekly docetaxel in metastatic hormone-sensitive prostate cancer (mHSPC). Also, a mechanism-based population pharmacokinetics/pharmacodynamics (PK/PD) model will be developed to provide a better understanding of the complex… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Hormone-Sensitive Prostate Cancer
- What is being tested?
- docetaxel 50mg/m2 and docetaxel 75mg/m2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2018to 30 Apr 2029
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed prostate cancer with EXTENSIVE metastatic disease and have been on androgen deprivation therapy for <90 days. Hormonal therapy must not have commenced more than 90 days prior to study.
- Definition of extensive disease: Metastases involving at least one lesion in any bony structures beyond the vertebral column and pelvic bone or any involvement with viscera. In the absence of visceral lesion, there must be four or more bone lesions. Patients with disease limited to vertebral column and/or pelvis alone with or without lymph node or lymph node only disease involvement are not eligible for this trial.
- Age ≥18 years.
- ECOG performance status ≤2 (Karnofsky ≥60%).
- Patients must have normal organ and marrow function as defined below within four weeks prior to the study:
- Absolute neutrophil count ≥1,500/mcL
Show all 15Show fewer
- Platelets ≥100,000/mcL
- Total bilirubin less than ULN
- AST(SGOT)/ALT(SGPT) ≤1.5 × institutional upper limit of normal
- Alkaline phosphate ≤2.5 x ULN
- Creatinine clearance ≥ 30 mL/min calculated using the Cockcroft-Gault formula: Creatinine clearance for male (mL/min) = (140-age)*(body weight in kg)/(72 x serum creatinine in mg/dl)
- If a patient has had major surgery, the patient must be longer than four weeks post surgery and must have recovered from all toxicity prior to beginning protocol study.
- Peripheral neuropathy with Grade ≤1
- Patients may be enrolled if they have had prior palliative radiation therapy. However, this has to have been commenced within 30 days of starting androgen deprivation.
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Patients who are receiving any other investigational agents.
- Patients with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of hypersensitivity to docetaxel or polysorbate 80.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social dysfunction that could impair the ability of the patients to participate in the study or interfere with interpretation of study results.
- Docetaxel is a CYP3A4 substrate and caution should be taken with its use and any drugs known to interact with it. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated list such as http://medicine.iupui.edu/clinpharm/ddis/table.aspx; medical reference texts such as the Physicians' Desk Reference for this information. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product. Appendix B contains a list of known drugs that are contraindicated or have major interactions with docetaxel.
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for PK interactions with docetaxel. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
- Patients with prior docetaxel chemotherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40536
About this study
Official title: A Prospective Open-label, Randomized, Two-arm Pilot Study to Investigate the Toxicity and Pharmacokinetics of 2-Weekly and 3-Weekly Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer.
This study is designed to investigate the toxicity and pharmacokinetics (PK) of 2-weekly and 3-weekly docetaxel in metastatic hormone-sensitive prostate cancer (mHSPC). Also, a mechanism-based population pharmacokinetics/pharmacodynamics (PK/PD) model will be developed to provide a better understanding of the complex relationships between the drug exposure and toxicity profiles of docetaxel in mHSPC.
Read the detailed description
This pilot study is designed to investigate the toxicity and PK of 2-weekly and 3-weekly docetaxel in mHSPC. Furthermore, a mechanism-based population PK/ pharmacodynamics (PD) model will be developed to provide a better understanding of the complex relationships between the drug exposure and toxicity profiles of docetaxel in mHSPC. In addition, selected pro-inflammatory and macrophage-associated cytokines will be collected to assess the potential role of these cytokines as the early markers of docetaxel resistance in patients with mHSPC. (Cytokines: macrophage inhibitory cytokine 1 (MIC1), interleukin (IL)-1ra, IL-1β, IL-4, IL-6, IL-12, and IFNγ). Serological response, defined as a prostate-specific antigen (PSA) level of <0.2 ng/mL at 12 months, and progression-free survival at 12 months are selected as the secondary clinical endpoints of the study.
- Being tested
- docetaxel 50mg/m2, docetaxel 75mg/m2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxel 50mg/m2Drug
50 mg/m2 of docetaxel will be given on day 1 every 14 days
docetaxel 75mg/m2Drug
75 mg/m2 of docetaxel will be given on day 1 every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Every two weeks docetaxel | Experimental | 50 mg/m2 of docetaxel will be given on day 1 every 14 days over one hour IV infusion for up to 9 cycles (1 cycle = 14 days) Receives: Drug: docetaxel 50mg/m2 |
| Every three weeks docetaxel | Active comparator | 75 mg/m2 of docetaxel will be given on day 1 every 21 days over one hour IV infusion for up to 6 cycles (1 cycle = 21 days) Receives: Drug: docetaxel 75mg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the neutropenia toxicity rate over time between the 2-weekly docetaxel dosing regimen and the 3-weekly docetaxel dosing regimen in metastatic hormone-sensitive prostate cancer.
Toxicity rate in each arm will be estimated based on a one-sided 90% confidence interval. Assuming at most a 31% neutropenia rate, a sample of 16 patients per arm will provide a one-sided 90% confidence interval upper limit equal to 50%.
Measured: Baseline; at each therapy cycle (a cycle is 2 weeks for the 2-weekly regimen, 3 weeks for the 3-weekly regimen); at 6-, 9-, and 12-months post treatment
Secondary outcomes (10)
Comparison of the pharmacokinetics (PK) parameter 'Cmax' (maximum concentration) between the 2-weekly docetaxel dosing regimen and the 3-weekly docetaxel dosing regimen in metastatic hormone-sensitive prostate cancer.
Individual docetaxel PK parameters will be estimated by non-compartmental method using Phoenix WinNonlin software (Certara Corporation, Princeton, NJ). Maximum concentration (Cmax) will be the observed value.
Measured: 0, 0.25, 0.75, 3, 6.5, and 24 hours post first docetaxel infusion; and, at the end of docetaxel infusion of the last cycle (a cycle is 2 weeks for the 2-weekly regimen, 3 weeks for the 3-weekly regimen)
Comparison of the pharmacokinetics (PK) parameter 'Tmax' (time to Cmax) between the 2-weekly docetaxel dosing regimen and the 3-weekly docetaxel dosing regimen in metastatic hormone-sensitive prostate cancer.
Individual docetaxel PK parameters will be estimated by non-compartmental method using Phoenix WinNonlin software (Certara Corporation, Princeton, NJ). Time to Cmax (Tmax) will be the observed value.
Measured: 0, 0.25, 0.75, 3, 6.5, and 24 hours post first docetaxel infusion; and, at the end of docetaxel infusion of the last cycle (a cycle is 2 weeks for the 2-weekly regimen, 3 weeks for the 3-weekly regimen)
Comparison of the pharmacokinetics (PK) parameter 'AUClast' between the 2-weekly docetaxel dosing regimen and the 3-weekly docetaxel dosing regimen in metastatic hormone-sensitive prostate cancer.
Area under the plasma concentration-time curve from zero to last observed time (AUClast) will be estimated using the trapezoidal rule.
Measured: 0, 0.25, 0.75, 3, 6.5, and 24 hours post first docetaxel infusion; and, at the end of docetaxel infusion of the last cycle (a cycle is 2 weeks for the 2-weekly regimen, 3 weeks for the 3-weekly regimen)
Comparison of the pharmacokinetics (PK) parameter 't1/2' (terminal half-life) between the 2-weekly docetaxel dosing regimen and the 3-weekly docetaxel dosing regimen in metastatic hormone-sensitive prostate cancer.
Terminal half-life (t1/2) will be calculated using the terminal linear portion of the log concentration-time curve.
Measured: 0, 0.25, 0.75, 3, 6.5, and 24 hours post first docetaxel infusion; and, at the end of docetaxel infusion of the last cycle (a cycle is 2 weeks for the 2-weekly regimen, 3 weeks for the 3-weekly regimen)
Comparison of the pharmacokinetics (PK) parameter 'AUC0-inf' (area under the curve from zero to infinity)' between the 2-weekly docetaxel dosing regimen and the 3-weekly docetaxel dosing regimen in metastatic hormone-sensitive prostate cancer.
AUC from zero to infinity (AUC0-inf) will be determined using the following equation:
AUC0-inf = AUClast + Cllast/Kel Where Clast is the observed concentration at the last time point and Kel is the slope of the terminal linear portion of the log concentration-time curve.
Measured: 0, 0.25, 0.75, 3, 6.5, and 24 hours post first docetaxel infusion; and, at the end of docetaxel infusion of the last cycle (a cycle is 2 weeks for the 2-weekly regimen, 3 weeks for the 3-weekly regimen)
Comparison of all grades of neutropenia (including febrile neutropenia) and other toxicities between the 2-weekly docetaxel dosing regimen and the 3-weekly docetaxel dosing regimen in metastatic hormone-sensitive prostate cancer.
Adverse event data and corresponding toxicity grades during the days of treatment will be summarized for each docetaxel dosing arm. Neutropenia rates will be estimated along with exact 90% one-sided binomial confidence intervals. Incidence, frequency, severity, and attribution tables for other toxicities will be generated.
Measured: up to 12 months after the first docetaxel dose
Development of a population system pharmacology model to describe the relationships between the PK (drug exposure) and PD (toxicity) of 2-weekly docetaxel in metastatic hormone-sensitive prostate cancer
The mechanism population PK/PD model will be developed using Monte-Carlo Expectation-Maximization algorithm implemented S-ADAPT software (version 1.57, BMSR, Log Angeles, CA).
Measured: CBC with differential and platelet will be collected: 24-hour +/- 3hrs; and 7 days +/- 1day after the first administration of 2-weekly docetaxel in cycle 1 to support the development of population PK/PD model
Development of a population system pharmacology model to describe the relationships between the PK (drug exposure) and PD (toxicity) of 3-weekly docetaxel in metastatic hormone-sensitive prostate cancer
The mechanism population PK/PD model will be developed using Monte-Carlo Expectation-Maximization algorithm implemented S-ADAPT software (version 1.57, BMSR, Log Angeles, CA).
Measured: CBC with differential and platelet will be collected: 24-hour +/- 3hrs; 7 days +/- 1day; and 14 days +/- 1day after the first administration of 3-weekly docetaxel in cycle 1 to support the development of population PK/PD model
Evaluation of the rate of complete serological response at 12 months
Defined as a prostate-specific antigen (PSA) level of less than 0.2 ng/mL
Measured: 12 months post treatment
Evaluation of the cytokine profile before and after treatment at different docetaxel dosage regimens
Descriptive statistics will be calculated for each cytokine parameter measured at each time point for each docetaxel dosing regimen and comparison from pre vs post-treatment within each arm will be performed using paired t-test while comparisons of cytokine parameters between docetaxel dosing groups will likewise be performed using two-sample t-test. Several cytokine parameters are evaluated and we will employ the Holm's p-value adjustment method to account for multiple testing between dosing group arms.
Measured: Baseline before chemotherapy; immediately prior to second dose (cycle length depends on dosing regimen) of chemotherapy; 30 minutes prior to chemotherapy at Week 7, and at Week 19; at Month 12 after start of first docetaxel dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start14 Feb 2018 (estimated)
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Apr 2029 (estimated)
Why it stopped: Study withdrawn for technical reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Hormone-Sensitive Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peng Wang, MD PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peng Wang, MD PhD, University of Kentucky
- Investigators
- Peng Wang, MD, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343977
- Sponsor's protocol ID
- MCC-17-GU-71
- Status last verified
- Jun 2018
- First submitted
- 6 Oct 2017
- Last updated
- 17 Jul 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Open-label, Randomized, Two-arm Pilot Study to Investigate the Toxicity and Pharmacokinetics of 2-Weekly and 3-Weekly Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer.
- ClinicalTrials.gov ID
- NCT03343977
- Acronym / sponsor ID
- MCC-17-GU-71
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn for technical reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Peng Wang, MD PhDUniversity, hospital or other
- Study start
- 14 Feb 2018 (estimated)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to investigate the toxicity and pharmacokinetics (PK) of 2-weekly and 3-weekly docetaxel in metastatic hormone-sensitive prostate cancer (mHSPC). Also, a mechanism-based population pharmacokinetics/pharmacodynamics (PK/PD) model will be developed to provide a better understanding of the complex relationships between the drug exposure and toxicity profiles of docetaxel in mHSPC.
Detailed description
This pilot study is designed to investigate the toxicity and PK of 2-weekly and 3-weekly docetaxel in mHSPC. Furthermore, a mechanism-based population PK/ pharmacodynamics (PD) model will be developed to provide a better understanding of the complex relationships between the drug exposure and toxicity profiles of docetaxel in mHSPC. In addition, selected pro-inflammatory and macrophage-associated cytokines will be collected to assess the potential role of these cytokines as the early markers of docetaxel resistance in patients with mHSPC. (Cytokines: macrophage inhibitory cytokine 1 (MIC1), interleukin (IL)-1ra, IL-1β, IL-4, IL-6, IL-12, and IFNγ). Serological response, defined as a prostate-specific antigen (PSA) level of <0.2 ng/mL at 12 months, and progression-free survival at 12 months are selected as the secondary clinical endpoints of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Every two weeks docetaxel | Experimental | Drug: docetaxel 50mg/m250 mg/m2 of docetaxel will be given on day 1 every 14 days over one hour IV infusion for up to 9 cycles (1 cycle = 14 days) |
| Every three weeks docetaxel | Active comparator | Drug: docetaxel 75mg/m275 mg/m2 of docetaxel will be given on day 1 every 21 days over one hour IV infusion for up to 6 cycles (1 cycle = 21 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have histologically or cytologically confirmed prostate cancer with EXTENSIVE metastatic disease and have been on androgen deprivation therapy for <90 days. Hormonal therapy must not have commenced more than 90 days prior to study.
- Definition of extensive disease: Metastases involving at least one lesion in any bony structures beyond the vertebral column and pelvic bone or any involvement with viscera. In the absence of visceral lesion, there must be four or more bone lesions. Patients with disease limited to vertebral column and/or pelvis alone with or without lymph node or lymph node only disease involvement are not eligible for this trial.
- Age ≥18 years.
- ECOG performance status ≤2 (Karnofsky ≥60%).
- Patients must have normal organ and marrow function as defined below within four weeks prior to the study:
Key exclusion criteria (7 listed)
- Patients who are receiving any other investigational agents.
- Patients with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of hypersensitivity to docetaxel or polysorbate 80.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social dysfunction that could impair the ability of the patients to participate in the study or interfere with interpretation of study results.
- Docetaxel is a CYP3A4 substrate and caution should be taken with its use and any drugs known to interact with it. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated list such as http://medicine.iupui.edu/clinpharm/ddis/table.aspx; medical reference texts such as the Physicians' Desk Reference for this information. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product. Appendix B contains a list of known drugs that are contraindicated or have major interactions with docetaxel.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| docetaxel 50mg/m250 mg/m2 of docetaxel will be given on day 1 every 14 days | Drug | Every two weeks docetaxel |
| docetaxel 75mg/m275 mg/m2 of docetaxel will be given on day 1 every 21 days | Drug | Every three weeks docetaxel |
Primary outcome
Comparison of the neutropenia toxicity rate over time between the 2-weekly docetaxel dosing regimen and the 3-weekly docetaxel dosing regimen in metastatic hormone-sensitive prostate cancer.
Time frame: Baseline; at each therapy cycle (a cycle is 2 weeks for the 2-weekly regimen, 3 weeks for the 3-weekly regimen); at 6-, 9-, and 12-months post treatment
Toxicity rate in each arm will be estimated based on a one-sided 90% confidence interval. Assuming at most a 31% neutropenia rate, a sample of 16 patients per arm will provide a one-sided 90% confidence interval upper limit equal to 50%.
10 secondary outcomes
Comparison of the pharmacokinetics (PK) parameter 'Cmax' (maximum concentration) between the 2-weekly docetaxel dosing regimen and the 3-weekly docetaxel dosing regimen in metastatic hormone-sensitive prostate cancer.
Time frame: 0, 0.25, 0.75, 3, 6.5, and 24 hours post first docetaxel infusion; and, at the end of docetaxel infusion of the last cycle (a cycle is 2 weeks for the 2-weekly regimen, 3 weeks for the 3-weekly regimen)
Comparison of the pharmacokinetics (PK) parameter 'Tmax' (time to Cmax) between the 2-weekly docetaxel dosing regimen and the 3-weekly docetaxel dosing regimen in metastatic hormone-sensitive prostate cancer.
Time frame: 0, 0.25, 0.75, 3, 6.5, and 24 hours post first docetaxel infusion; and, at the end of docetaxel infusion of the last cycle (a cycle is 2 weeks for the 2-weekly regimen, 3 weeks for the 3-weekly regimen)
Comparison of the pharmacokinetics (PK) parameter 'AUClast' between the 2-weekly docetaxel dosing regimen and the 3-weekly docetaxel dosing regimen in metastatic hormone-sensitive prostate cancer.
Time frame: 0, 0.25, 0.75, 3, 6.5, and 24 hours post first docetaxel infusion; and, at the end of docetaxel infusion of the last cycle (a cycle is 2 weeks for the 2-weekly regimen, 3 weeks for the 3-weekly regimen)
Comparison of the pharmacokinetics (PK) parameter 't1/2' (terminal half-life) between the 2-weekly docetaxel dosing regimen and the 3-weekly docetaxel dosing regimen in metastatic hormone-sensitive prostate cancer.
Time frame: 0, 0.25, 0.75, 3, 6.5, and 24 hours post first docetaxel infusion; and, at the end of docetaxel infusion of the last cycle (a cycle is 2 weeks for the 2-weekly regimen, 3 weeks for the 3-weekly regimen)
Comparison of the pharmacokinetics (PK) parameter 'AUC0-inf' (area under the curve from zero to infinity)' between the 2-weekly docetaxel dosing regimen and the 3-weekly docetaxel dosing regimen in metastatic hormone-sensitive prostate cancer.
Time frame: 0, 0.25, 0.75, 3, 6.5, and 24 hours post first docetaxel infusion; and, at the end of docetaxel infusion of the last cycle (a cycle is 2 weeks for the 2-weekly regimen, 3 weeks for the 3-weekly regimen)
Comparison of all grades of neutropenia (including febrile neutropenia) and other toxicities between the 2-weekly docetaxel dosing regimen and the 3-weekly docetaxel dosing regimen in metastatic hormone-sensitive prostate cancer.
Time frame: up to 12 months after the first docetaxel dose
Development of a population system pharmacology model to describe the relationships between the PK (drug exposure) and PD (toxicity) of 2-weekly docetaxel in metastatic hormone-sensitive prostate cancer
Time frame: CBC with differential and platelet will be collected: 24-hour +/- 3hrs; and 7 days +/- 1day after the first administration of 2-weekly docetaxel in cycle 1 to support the development of population PK/PD model
Development of a population system pharmacology model to describe the relationships between the PK (drug exposure) and PD (toxicity) of 3-weekly docetaxel in metastatic hormone-sensitive prostate cancer
Time frame: CBC with differential and platelet will be collected: 24-hour +/- 3hrs; 7 days +/- 1day; and 14 days +/- 1day after the first administration of 3-weekly docetaxel in cycle 1 to support the development of population PK/PD model
Evaluation of the rate of complete serological response at 12 months
Time frame: 12 months post treatment
Evaluation of the cytokine profile before and after treatment at different docetaxel dosage regimens
Time frame: Baseline before chemotherapy; immediately prior to second dose (cycle length depends on dosing regimen) of chemotherapy; 30 minutes prior to chemotherapy at Week 7, and at Week 19; at Month 12 after start of first docetaxel dose.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peng Wang, MD, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing docetaxel 50mg/m2 and docetaxel 75mg/m2 in people with Metastatic Hormone-Sensitive Prostate Cancer, run by Peng Wang, MD PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the neutropenia toxicity rate over time between the 2-weekly docetaxel dosing regimen and the 3-weekly docetaxel dosing regimen in metastatic hormone-sensitive prostate cancer. (time frame: Baseline; at each therapy cycle (a cycle is 2 weeks for the 2-weekly regimen, 3 weeks for the 3-weekly regimen); at 6-, 9-, and 12-months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.