Liposome Encapsulated Docetaxel (LE-DT) in Patients With Solid Tumors

NCT01151384 | Completed Phase 1 DMC

• 1 other identifier: LE-DT-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Liposome Encapsulated Docetaxel (LE-DT) is a novel proprietary delivery system of docetaxel developed by NeoPharm, Inc. In this Phase I study, the LE-DT was evaluated for the maximum tolerated dose and dose limiting toxicity (DLT) in patients with advance solid tumors. It was also evaluated for pharmacokinetic and anti-tumor effects.

Conditions

Solid Tumors

Keywords

Cancer Patients

Outcome Measures

Primary Outcomes (1)

• To evaluate the tolerability and safety

  This Phase I, open-label, dose-escalation study was designed to determine the maximum tolerated dose (MTD) of LE-DT in patients with advanced cancer. LE-DT was administered by intravenous infusion, over 1 hour, once every 21 days until occurrence of disease progression or toxicity requiring early treatment discontinuation. Dose escalation was not done until the safety and tolerability at a given dose level has been confirmed.

  1 year

Secondary Outcomes (1)

• To evaluate the pharmacokinetic and anti-tumor effect

  1 year

Study Arms (1)

LE-DT

EXPERIMENTAL

Drug: LE-DT

Interventions

LE-DT DRUG

Intravenous infusion, Upto 5 dose levels have been studied i.e. 50, 65, 85, 110 and 132 mg/m2, Every 3 weeks

Also known as: 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:

• To be included in this study, patients must meet the following criteria:
• Be ≥18 years of age.
• Have advanced (local and/or metastatic) histologically documented cancer considered unresponsive to available conventional modalities or treatments.
• Have an ECOG Performance Status of 0-2.
• Have recovered from acute toxicities of prior treatment:
• weeks must have elapsed since receiving any investigational agent.
• weeks must have elapsed since receiving any radiotherapy, or treatment with cytotoxic or biologic agents (≥6 weeks for mitomycin or nitrosoureas). Chronic treatment with non-investigational gonadotropin-releasing hormone analogs or other hormonal or supportive care is permitted.
• \>6 months must have elapsed since receiving a high-dose chemotherapy regimen with stem cell support.
• weeks must have elapsed since any prior surgery or granulocyte-stimulating growth factor therapy.
• months must have elapsed since any prior treatment with docetaxel. 5. Be in adequate condition as evidenced by the following clinical laboratory values:
• Absolute neutrophil count (ANC) ≥1,500/mm3.
• Platelets ≥100,000/mm3.
• Hemoglobin ≥9.0 g/dL.
• Albumin ≥3.0 g/dL.
• Serum creatinine ≤2.0 mg/dL.

You may not qualify if:

• Patients are excluded from this study for the following:
• Active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease).
• Any active infection requiring parenteral or oral antibiotic treatment.
• Known infection with human immunodeficiency virus or hepatitis virus.
• Active heart disease including myocardial infarction or congestive heart failure within the previous 6 months, symptomatic coronary artery disease, or arrhythmias currently requiring medication.
• Known or suspected active central nervous system metastasis. (Patients stable 8 weeks after completion of treatment for central nervous system metastasis are eligible.)
• Impending or symptomatic spinal cord compression or carcinomatous meningitis.
• Having pre-existing clinically significant neuropathy (NCI CTCAE Grade ≥ 2 neuromotor or Grade ≥ 2 neurosensory) except for abnormalities due to cancer.
• Having failed a docetaxel-containing regimen.
• Having known non-controllable hypersensitivity to docetaxel or liposomes.
• Currently receiving any other standard or investigational treatment for cancer or any other investigational agent for any indication.
• Requiring immediate palliative treatment of any kind including surgery and/or radiotherapy.
• Female patients who are pregnant or breast-feeding.
• Unwilling or unable to follow protocol requirements.
• Any condition which, in the Investigator's opinion, deems the patient an unsuitable candidate to receive study drug.

Sponsors & Collaborators

• INSYS Therapeutics Inc: lead

Study Sites (2)

TGEN/Scottsdale Clinical Research Institute

Scottsdale, Arizona, 85258, United States

Location

Lombardi Comprehensive Cancer Center, Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

Related Publications (1)

• Deeken JF, Slack R, Weiss GJ, Ramanathan RK, Pishvaian MJ, Hwang J, Lewandowski K, Subramaniam D, He AR, Cotarla I, Rahman A, Marshall JL. A phase I study of liposomal-encapsulated docetaxel (LE-DT) in patients with advanced solid tumor malignancies. Cancer Chemother Pharmacol. 2013 Mar;71(3):627-33. doi: 10.1007/s00280-012-2048-y. Epub 2012 Dec 30.

  PMID: 23274395 DERIVED

Study Officials

• John L Marshall, MD

  Georgetowm University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 23, 2010
• First Posted: June 28, 2010
• Study Start: February 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 4, 2011

Record last verified: 2011-06

Locations

US (2)