Efficacy and Safety Study of LE-DT to Treat Locally Advanced or Metastatic Pancreatic Cancer

NCT01186731 | Completed Phase 2 DMC

• 1 other identifier: Protocol LE-DT 202
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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:

1. 1.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
2. 2.To evaluate the progression-free survival and overall survival
3. 3.To correlate secreted protein acid rich in cysteine expression with tumor response
4. 4.To evaluate the safety of LE-DT, in particular peripheral neuropathy, water retention as well as myelotoxicity
5. 5.To correlate pharmacogenetic variations in patients with LE-DT pharmacodynamic endpoints, including toxicities.

Conditions

Pancreatic Cancer

Keywords

SPARC (secreted protein acid rich in cysteine); serum Carbohydrate Antigen CA 19-9

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• SPARC tumor expression following the treatment of LE-DT at 110 mg/m2 dose level

  1 year

Study Arms (1)

Liposome Entrapped Docetaxel (LE-DT)

EXPERIMENTAL

Drug: Liposome Entrapped Docetaxel (LE-DT)

Interventions

Liposome Entrapped Docetaxel (LE-DT) DRUG

110 mg/m2 (IV)in vein on day 1 of each 21 day cycle , 6 cycles, until progression or unacceptable toxicity

Also known as: Liposomal Docetaxel, LE-DT

Liposome Entrapped Docetaxel (LE-DT)

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• INSYS Therapeutics Inc: lead

Study Sites (1)

Lombardi Cancer Center, Georgetown University Medical Center

Washington D.C., District of Columbia, 20007-2197, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• John L Marshall, M.D.

  Lombardi Cancer Center, Georgetown University Medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2010
• First Posted: August 23, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 12, 2012

Record last verified: 2012-08

Locations

US (1)