Pancreatic CancerPhase 2NCT01186731
Efficacy and Safety Study of LE-DT to Treat Locally Advanced or Metastatic Pancreatic Cancer
A Phase 2 study testing Liposome Entrapped Docetaxel (LE-DT) in people with Pancreatic Cancer, run by INSYS Therapeutics Inc at 1 site 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-microtubule agent that prevents cell division. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic 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
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Dec 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is 18 years or older, male and female.
- Patient has histopathologically confirmed diagnosis of adenocarcinoma of the pancreas. Patients with islet cell neoplasms are excluded. Biopsy sample must be available for SPARC assay.
- Patients must have clinical or radiographic evidence of locally advanced or metastatic pancreatic cancer with measurable disease.
- Male or non-pregnant and non-lactating female:
- If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test (β hCG) documented within 72 hours of the first administration of study drug.
- If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator.
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- Patient can be newly-diagnosed without prior treatment or have failed initial adjuvant treatment with either gemcitabine, 5-FU or capecitabine with or without radiation therapy.
- Patient has the following blood counts at baseline:
- ANC greater than or equal to 1500 per uL
- Platelets greater than or equal to 100000 per uL
- Hgb greater than or equal to 9 g per dL
- Patient has the following blood chemistry levels at baseline:
- AST (SGOT), ALT (SGPT) less than or equal to 2.5 times of the upper limit of normal range (ULN), unless liver metastases are present, then less than or equal 5 times of the ULN is allowed
- Bilirubin less than or equal to 1.5 times of the ULN
- Serum creatinine less than or equal to 1.5 times of the ULN or calculated clearance greater than or equal to 60 mL/min for patients with serum creatinine levels above the institutional normal value.
- Patient has acceptable coagulation profile as indicated by a Prothrombin time (PT) and Partial Thromboplastin Time (PTT) within normal limits (plus or minus 15%) unless explained by the use of anticoagulants
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patient has one or more metastatic lesions or locally advanced primary tumor measurable by CT or MRI.
- Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board-approved written informed consent form prior to receiving any study related procedure.
Who cannot join
- Patient has known brain metastases.
- Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- Patient has known infection with HIV, hepatitis B, or hepatitis C.
- Patient has undergone major surgery, other than diagnostic surgery (i.e. surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
- Patient who have received any other treatment for pancreatic cancer including radiotherapy, chemotherapy or any investigational therapy with the exception of initial adjuvant treatment including either gemcitabine, 5-FU or capecitabine with or without radiation therapy
- Patient has a history of allergy or hypersensitivity to the study drug.
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- Patient has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug.
- Patient has pre-existing peripheral neuropathy of Grade >1 based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
- Patient is unwilling or unable to comply with study procedures.
- Patient is enrolled in any other clinical or investigational trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lombardi Cancer Center, Georgetown University Medical Center
Washington D.C., District of Columbia, 20007-2197
About this study
Official title: A Multicenter, Open-Label, Phase II Study of LE-DT for Efficacy and Safety in Patients With Locally Advanced or Metastatic Pancreatic Cancer
LE-DT is a novel, proprietary delivery system of docetaxel developed by NeoPharm, Inc. Docetaxel (currently marketed as Taxotere) is an anti-microtubule agent that prevents cell division. 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. In addition, docetaxel has shown positive activity of protein bound taxane therapy in treating patients with pancreatic cancer. The current Phase II study is designed to accomplish the following objectives:
- Assess the antitumor effect of 110 mg/m2 LE-DT administered intravenous (IV) every three weeks in pancreatic cancer patients with locally advanced or metastatic disease
- To evaluate the progression-free survival and overall survival
- To correlate secreted protein acid rich in cysteine expression with tumor response
- To evaluate the safety of LE-DT, in particular peripheral neuropathy, water retention as well as myelotoxicity
- To correlate pharmacogenetic variations in patients with LE-DT pharmacodynamic endpoints, including toxicities.
- Conditions
- Pancreatic Cancer
- Being tested
- Liposome Entrapped Docetaxel (LE-DT)
- Keywords
- SPARC (secreted protein acid rich in cysteine), serum Carbohydrate Antigen CA 19-9
- Medical subject headings
- Pancreatic 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 Liposomal Docetaxel, LE-DT
110 mg/m2 (IV)in vein on day 1 of each 21 day cycle , 6 cycles, until progression or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Liposome Entrapped Docetaxel (LE-DT) | Experimental | Not described Receives: Drug: Liposome Entrapped Docetaxel (LE-DT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate of tumor size reduction at 110 mg/m2 LE-DT dose level
Measurable disease response will be assessed by radiographic method, CT or MRI, along with serum CA 19-9 after completed 2, 4 and 6 cycle.
Measured: 1 year
Secondary outcomes (1)
SPARC tumor expression following the treatment of LE-DT at 110 mg/m2 dose level
SPARC tumor expression will be assessed as a potential predictor of tumor response
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 posted23 Aug 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- INSYS Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John L Marshall, M.D., Principal investigator, Lombardi Cancer Center, Georgetown University Medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186731
- Sponsor's protocol ID
- Protocol LE-DT 202
- Status last verified
- Aug 2012
- First submitted
- 18 Aug 2010
- Last updated
- 12 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2012. 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 Locally Advanced or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01186731
- Acronym / sponsor ID
- Protocol LE-DT 202
- Conditions
- Pancreatic Cancer
- Keywords
- SPARC (secreted protein acid rich in cysteine), serum Carbohydrate Antigen CA 19-9
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- INSYS Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 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-microtubule agent that prevents cell division. 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. In addition, docetaxel has shown positive activity of protein bound taxane therapy in treating patients with pancreatic cancer. The current Phase II study is designed to accomplish the following objectives:
- Assess the antitumor effect of 110 mg/m2 LE-DT administered intravenous (IV) every three weeks in pancreatic cancer patients with locally advanced or metastatic disease
- To evaluate the progression-free survival and overall survival
- To correlate secreted protein acid rich in cysteine expression with tumor response
- To evaluate the safety of LE-DT, in particular peripheral neuropathy, water retention as well as myelotoxicity
- To correlate pharmacogenetic variations in patients with LE-DT pharmacodynamic endpoints, including toxicities.
Study design
- 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patient is 18 years or older, male and female.
- Patient has histopathologically confirmed diagnosis of adenocarcinoma of the pancreas. Patients with islet cell neoplasms are excluded. Biopsy sample must be available for SPARC assay.
- Patients must have clinical or radiographic evidence of locally advanced or metastatic pancreatic cancer with measurable disease.
- Male or non-pregnant and non-lactating female:
- Patient can be newly-diagnosed without prior treatment or have failed initial adjuvant treatment with either gemcitabine, 5-FU or capecitabine with or without radiation therapy.
Key exclusion criteria (10 listed)
- Patient has known brain metastases.
- Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- Patient has known infection with HIV, hepatitis B, or hepatitis C.
- Patient has undergone major surgery, other than diagnostic surgery (i.e. surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
- Patient who have received any other treatment for pancreatic cancer including radiotherapy, chemotherapy or any investigational therapy with the exception of initial adjuvant treatment including either gemcitabine, 5-FU or capecitabine with or without radiation therapy
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: Liposomal Docetaxel, LE-DT110 mg/m2 (IV)in vein on day 1 of each 21 day cycle , 6 cycles, until progression or unacceptable toxicity | Drug | Liposome Entrapped Docetaxel (LE-DT) |
Primary outcome
Response rate of tumor size reduction at 110 mg/m2 LE-DT dose level
Time frame: 1 year
Measurable disease response will be assessed by radiographic method, CT or MRI, along with serum CA 19-9 after completed 2, 4 and 6 cycle.
1 secondary outcome
SPARC tumor expression following the treatment of LE-DT at 110 mg/m2 dose level
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2012.
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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.
John L Marshall, M.D. principal investigator
Lombardi Cancer Center, Georgetown University Medical center
1 site 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 Pancreatic Cancer, run by INSYS Therapeutics Inc 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 19 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: finished, as of the sponsor's last update on 12 Sep 2012. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response rate of tumor size reduction at 110 mg/m2 LE-DT dose level (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 Sep 2012.