NCT00080418

Brief Summary

The purpose of this study is to determine the highest dose of Liposome Entrapped Paclitaxel Easy to Use formulation (LEP-ETU) that can be safely administered by an intravenous infusion to patients with advanced cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2003

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

July 4, 2011

Status Verified

June 1, 2011

Enrollment Period

2 years

First QC Date

March 30, 2004

Last Update Submit

June 30, 2011

Conditions

Neoplasm

Keywords

neoplasmcancerNeoPharmliposomesTaxolpaclitaxelanti-canceradvanced neoplasmadvanced cancerchemotherapyrefractory cancermetastatic cancer

Interventions

Liposome Entrapped Paclitaxel Easy to UseDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have advanced (local and/or metastatic) histologically documented cancer considered unresponsive to available conventional modalities or treatments, and no life-prolonging therapy or therapy with a greater potential for patient benefit is available.
  • Patients must have an ECOG Performance Status of 0-2.
  • Patients must have recovered from acute toxicities of prior treatment:
  • ≥ 4 weeks must have elapsed since receiving any investigational agent.
  • ≥ 3 weeks must have elapsed since receiving any radiotherapy, or treatment with cytotoxic or biologic agents (≥ 6 weeks for mitomycin or nitrosureas). 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 regime with stem cell support.
  • ≥ 2 weeks must have elapsed since any prior surgery or granulocyte-stimulating growth factor therapy.
  • Patients must be in adequate condition as evidenced by the following clinical laboratory values:
  • Absolute neutrophil count (ANC) ≥ 1,500/mm3
  • Platelet count ≥ 100,000/mm3
  • Hemoglobin ≥ 9.0 g/dL
  • Albumin ≥ 3.0 g/dl
  • Serum creatinine ≤ 2.0 mg/dL
  • Total bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN).
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase ≤2.5 x ULN.
  • +2 more criteria

You may not qualify if:

  • 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 (HIV) 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 received prior treatment with LEP-ETU.
  • Having known hypersensitivity to paclitaxel or liposomes.
  • Receiving any agent that could interfere with LEP-ETU metabolism, including CYP3A4 inducers and inhibitors within 3 weeks prior to, or while receiving, study drug. (Please refer to http://medicine.iupui.edu/flockhart/ for a list of such agents).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Cancer Institute of New Jersey - University of Medicine and Dentistry of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Fox Chase Temple Cancer Center - Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

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

March 30, 2004

First Posted

April 2, 2004

Study Start

July 1, 2003

Primary Completion

July 1, 2005

Study Completion

June 1, 2010

Last Updated

July 4, 2011

Record last verified: 2011-06

Locations

US(3)