- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01188408
Efficacy and Safety Study of LE-DT to Treat Metastatic Castrate Resistant Prostate Cancer
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)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20007
- Georgetown University Medical Center
-
-
Oregon
-
Portland, Oregon, United States, 97213-2933
- Providence Portland Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
- 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.
Exclusion Criteria:
- 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.
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).
Study Plan
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: Liposome Entrapped Docetaxel (LE-DT)
Disease status and tumor responses/progression is assessed in accordance to the RECIST guideline
|
110 mg/m2 IV (in vein) on day 1 of each 21 day cycle, 6 cycles or until disease progression or unacceptable toxicity
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of serum PSA
Time Frame: 1 year
|
Measure serum PSA after 2, 4 and 6 cycles of treatment
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RECIST method assessment
Time Frame: 1 year
|
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
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nancy A Dawson, M.D., Georgetown University
- Principal Investigator: Brendan D Curti, M.D., Providence Health & Services
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LE-DT 201
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.
Clinical Trials on Prostate Cancer
-
Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
-
University of Southern CaliforniaNational Cancer Institute (NCI); SanofiTerminatedDiarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.TerminatedRandomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...United States
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ryan Kohlbrenner, MDRadiological Society of North AmericaCompletedProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...United States
-
Ohio State University Comprehensive Cancer CenterRiverside Methodist HospitalCompletedStage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...United States
-
Barbara Ann Karmanos Cancer InstituteGenentech, Inc.CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
Clinical Trials on Liposome Entrapped Docetaxel (LE-DT)
-
INSYS Therapeutics IncCompletedPancreatic CancerUnited States
-
INSYS Therapeutics IncCompletedSolid TumorsUnited States
-
Shenyang Pharmaceutical UniversityUnknown
-
INSYS Therapeutics IncCompleted
-
INSYS Therapeutics IncCompletedNeoplasmUnited States
-
INSYS Therapeutics IncCompletedNeoplasmUnited States, Germany, Netherlands
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Not yet recruitingAdvanced Hepatocellular Carcinoma
-
PharmaEngineCompletedStomach Neoplasms | Esophageal NeoplasmsKorea, Republic of, Spain, Taiwan, Bosnia and Herzegovina, United Kingdom, Croatia
-
Tianjin Medical University Cancer Institute and...UnknownChemotherapy Effect | Susceptibility, GeneticChina
-
Hebei Medical University Fourth HospitalCompleted