Status:
COMPLETED
Liposome Encapsulated Docetaxel (LE-DT) in Patients With Solid Tumors
Lead Sponsor:
INSYS Therapeutics Inc
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 an...
Detailed Description
Liposome Entrapped Doxetaxel (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 prev...
Eligibility Criteria
Inclusion
- 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:
- 4 weeks must have elapsed since receiving any investigational agent.
- 4 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.
- 2 weeks must have elapsed since any prior surgery or granulocyte-stimulating growth factor therapy.
- 12 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.
- Total bilirubin ≤1.5 x institutional upper limit normal (ULN).
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase ≤2.5 x ULN.
- 6\. Patients (male and female) must be willing to practice an effective method of birth control during the study.
- 7\. Patient or legal representative must understand the investigational nature of this study and sign an Institutional Review Board (IRB)/Independent Ethics Committee approved written informed consent form prior to treatment.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01151384
Start Date
February 1 2008
End Date
May 1 2010
Last Update
July 4 2011
Active Locations (2)
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1
TGEN/Scottsdale Clinical Research Institute
Scottsdale, Arizona, United States, 85258
2
Lombardi Comprehensive Cancer Center, Georgetown University
Washington D.C., District of Columbia, United States, 20057