Prostate CancerPhase 2NCT01188408
Efficacy and Safety Study of LE-DT to Treat Metastatic Castrate Resistant Prostate Cancer
A Phase 2 study testing Liposome Entrapped Docetaxel (LE-DT) in people with Prostate Cancer, run by INSYS Therapeutics Inc at 2 sites in United States.
Trial summary
LE-DT is a novel, proprietary delivery system of docetaxel developed by NeoPharm, Inc. Docetaxel (currently marketed as Taxotere) is an anti-microtubular network agent and is one of the most active agents in the treatment of metastatic castrate resistant prostate cancer (CRPC) and other variety of cancers. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Liposome Entrapped Docetaxel (LE-DT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2010to Sep 2011
- Phase
- Phase 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
- Be 18 years or older and male.
- Have histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.
- Patients without evidence of PSA progression must have clinical or radiographic evidence of metastatic disease.
- Must have castrate levels of testosterone (serum testosterone less than 50ng/dl) by either being on androgen ablation therapy with a luteinizing hormone-releasing hormone (LHRH) agonist or have had a prior bilateral orchiectomy.
- Patients must have documented evidence of disease progression: progressive disease is defined as a minimum of three consecutive elevations in PSA each obtained a minimum of one week apart with the last value being greater than 2 ng/mL and/or new metastatic lesions on bone scan (minimum of 2) and/or new or progressive disease on CT or MRI scan.
- For patients on an antiandrogen (flutamide, nilutamide, bicalutamide)
Show all 26Show fewer
- If given as part of first line therapy or for patients who did respond to antiandrogen second line therapy, the patient must demonstrate progression of disease at least 4 weeks beyond discontinuation of such agents to rule out an antiandrogen withdrawal response.
- If given as a second line therapy and the patient did not respond or had a decline in PSA for less than 3 months, it is not required to observe for a withdrawal response.
- Chemotherapy-naïve patients (unlimited prior regimens of hormonal therapy are acceptable).
- Have no other malignancy within the past five years, except non-melanoma, skin cancer.
- Have recovered from acute toxicities of prior treatment:
- Greater than or equal to 4 weeks must have elapsed since receiving hormonal therapy (except for chronic non-investigational gonadotropin releasing hormone analogs or other primary androgen suppressive therapy which are required), biologic agents or any investigational agent (palliative bisphosphonate therapy for bone pain can be administered as clinically indicated).
- Greater than or equal to 4 weeks must have elapsed since receiving any radiotherapy
- Greater than or equal to 2 weeks must have elapsed since any prior surgery or granulocyte-stimulating growth factor therapy.
- Have the following hematology levels at Baseline:
- Absolute Neutrophil Count (ANC) greater than or equal to1,500 x 106 cells/L
- Platelets greater than or equal to 100 x 109 cells/L
- Hemoglobin greater than or equal to 9 g/L.
- Have the following chemistry levels at Baseline:
- AST (SGOT), ALT (SGPT) less than or equal to 1.5 x ULN
- Total bilirubin less than or equal to 1.5 ULN
- Creatinine less than or equal to 1.5 ULN; or 24-hour creatinine clearance greater than 60 mL/min
- Normal serum electrolytes and magnesium levels
- Have a life expectancy of greater than or equal to 12 weeks.
- Have an Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2.
- Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee (EC)/Institutional Review Board (IRB)-approved written informed consent form (ICF) prior to receiving any study related procedure.
Who cannot join
- Patient has radiographic evidence of active (symptomatic, untreated) intraparenchymal brain metastases; any meningeal metastases; or asymptomatic untreated intraparenchymal brain metastases requiring treatment.
- Patient has received prior chemotherapy for metastatic prostate cancer.
- Patient has a known infection with human immunodeficiency virus or active viral hepatitis.
- Patient has active heart disease including myocardial infarction or congestive heart failure within the previous 6 months, symptomatic coronary artery disease, or uncontrolled arrhythmias.
- Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug (e.g., uncontrolled bleeding or bleeding diathesis).
- Any active infection requiring parenteral or oral antibiotics.
Show all 10Show fewer
- Patient treated with any of the following:
- Taxol, Taxotere or Abraxane for prostate cancer or any prior malignancy
- Concurrent radiation therapy (except for palliative radiotherapy for symptomatic bone metastasis which can be administered as clinically indicated)
- Patient has pre-existing peripheral neuropathy of Grade greater than 1 based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Providence Portland Medical center
Portland, Oregon, 97213-2933
Georgetown University Medical center
Washington D.C., District of Columbia, 20007
About this study
Official title: A Multicenter, Open-Label, Phase II Study of LE-DT for Efficacy and Safety in Patients With Metastatic Castrate Resistant Prostate Cancer
LE-DT is a novel, proprietary delivery system of docetaxel developed by NeoPharm, Inc. Docetaxel (currently marketed as Taxotere) is an anti-microtubular network agent and is one of the most active agents in the treatment of metastatic castrate resistant prostate cancer (CRPC) and other variety of cancers. Taxotere has poor solubility and is designed to be administered with Tween 80 in ethanol. This vehicle causes acute hypersensitivity reaction. By removing toxic detergent used in Taxotere, the form of LE-DT, shows reduced toxicity and comparable therapeutic efficacy in pre-clinical study. The clinical evidence obtained from the NeoPharm Phase I study shows fewer side effects and possibly administered at higher dose to induce greater effectiveness of LE-DT. The current Phase II study is designed to accomplish the following objectives:
- Assess the antitumor effect indicator serum prostate specific antigen (PSA) following the intravenous (IV) administration of 110 mg/m2 LE-DT every three weeks in patients with metastatic castrate resistant prostate cancer
- To evaluate the measurable soft tissue disease response using the response evaluation criteria in solid tumor (RECIST) methodology
- To evaluate the progression-free survival (PFS) and overall survival (OS)
- To correlate PSA expression with tumor response
- To evaluate the safety of LE-DT at 110 mg/m2 level, in particular peripheral neuropathy, water retention as well as myelotoxicity
- To evaluate the quality of life (QOL)
- Conditions
- Prostate Cancer
- Being tested
- Liposome Entrapped Docetaxel (LE-DT)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposome Entrapped Docetaxel (LE-DT)Drug
Also called LE-DT, Liposomal Docetaxel
110 mg/m2 IV (in vein) on day 1 of each 21 day cycle, 6 cycles or until disease progression or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Liposome Entrapped Docetaxel (LE-DT) | Experimental | Disease status and tumor responses/progression is assessed in accordance to the RECIST guideline Receives: Drug: Liposome Entrapped Docetaxel (LE-DT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of serum PSA
Measure serum PSA after 2, 4 and 6 cycles of treatment
Measured: 1 year
Secondary outcomes (1)
RECIST method assessment
Measurable soft tissue disease response based on the RECIST method, PFS, and OS will also be assessed after 2, 4 and 6 cycle to determine the treatment effectiveness with LE-DT after treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Why it stopped: Study shut-down in 12/2010 when NeoPharm merged with Insys.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- INSYS Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nancy A Dawson, M.D., Principal investigator, Georgetown UniversityBrendan D Curti, M.D., Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188408
- Sponsor's protocol ID
- LE-DT 201
- Status last verified
- Mar 2018
- First submitted
- 19 Aug 2010
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase II Study of LE-DT for Efficacy and Safety in Patients With Metastatic Castrate Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT01188408
- Acronym / sponsor ID
- LE-DT 201
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study shut-down in 12/2010 when NeoPharm merged with Insys.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- INSYS Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 25 Aug 2010 (estimated)
- 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.
LE-DT is a novel, proprietary delivery system of docetaxel developed by NeoPharm, Inc. Docetaxel (currently marketed as Taxotere) is an anti-microtubular network agent and is one of the most active agents in the treatment of metastatic castrate resistant prostate cancer (CRPC) and other variety of cancers. Taxotere has poor solubility and is designed to be administered with Tween 80 in ethanol. This vehicle causes acute hypersensitivity reaction. By removing toxic detergent used in Taxotere, the form of LE-DT, shows reduced toxicity and comparable therapeutic efficacy in pre-clinical study. The clinical evidence obtained from the NeoPharm Phase I study shows fewer side effects and possibly administered at higher dose to induce greater effectiveness of LE-DT. The current Phase II study is designed to accomplish the following objectives:
- Assess the antitumor effect indicator serum prostate specific antigen (PSA) following the intravenous (IV) administration of 110 mg/m2 LE-DT every three weeks in patients with metastatic castrate resistant prostate cancer
- To evaluate the measurable soft tissue disease response using the response evaluation criteria in solid tumor (RECIST) methodology
- To evaluate the progression-free survival (PFS) and overall survival (OS)
- To correlate PSA expression with tumor response
- To evaluate the safety of LE-DT at 110 mg/m2 level, in particular peripheral neuropathy, water retention as well as myelotoxicity
- To evaluate the quality of life (QOL)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liposome Entrapped Docetaxel (LE-DT) | Experimental | Drug: Liposome Entrapped Docetaxel (LE-DT)Disease status and tumor responses/progression is assessed in accordance to the RECIST guideline |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Be 18 years or older and male.
- Have histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.
- Patients without evidence of PSA progression must have clinical or radiographic evidence of metastatic disease.
- Must have castrate levels of testosterone (serum testosterone less than 50ng/dl) by either being on androgen ablation therapy with a luteinizing hormone-releasing hormone (LHRH) agonist or have had a prior bilateral orchiectomy.
- Patients must have documented evidence of disease progression: progressive disease is defined as a minimum of three consecutive elevations in PSA each obtained a minimum of one week apart with the last value being greater than 2 ng/mL and/or new metastatic lesions on bone scan (minimum of 2) and/or new or progressive disease on CT or MRI scan.
Key exclusion criteria (10 listed)
- Patient has radiographic evidence of active (symptomatic, untreated) intraparenchymal brain metastases; any meningeal metastases; or asymptomatic untreated intraparenchymal brain metastases requiring treatment.
- Patient has received prior chemotherapy for metastatic prostate cancer.
- Patient has a known infection with human immunodeficiency virus or active viral hepatitis.
- Patient has active heart disease including myocardial infarction or congestive heart failure within the previous 6 months, symptomatic coronary artery disease, or uncontrolled arrhythmias.
- Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug (e.g., uncontrolled bleeding or bleeding diathesis).
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 |
|---|---|---|
| Liposome Entrapped Docetaxel (LE-DT)Also: LE-DT, Liposomal Docetaxel110 mg/m2 IV (in vein) on day 1 of each 21 day cycle, 6 cycles or until disease progression or unacceptable toxicity | Drug | Liposome Entrapped Docetaxel (LE-DT) |
Primary outcome
Assessment of serum PSA
Time frame: 1 year
Measure serum PSA after 2, 4 and 6 cycles of treatment
1 secondary outcome
RECIST method assessment
Time frame: 1 year
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 12 Mar 2018.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Nancy A Dawson, M.D. principal investigator
Georgetown University
Brendan D Curti, M.D. principal investigator
Providence Health & Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liposome Entrapped Docetaxel (LE-DT) in people with Prostate Cancer, run by INSYS Therapeutics Inc at 2 sites 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 26 inclusion and 10 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 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 phase mean?
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?
Assessment of serum PSA (time frame: 1 year). 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 12 Mar 2018.