Study of Patupilone in Patients With Brain Metastasis From Non-small Cell Lung Cancer

February 17, 2021 updated by: Novartis Pharmaceuticals

An Open-label, Multi-center, Phase II Study to Evaluate the Activity of Patupilone (EPO906), in the Treatment of Recurrent or Progressive Brain Metastases in Patients With Non-small Cell Lung Cancer.

The study objective is to evaluate the safety and efficacy of patupilone with respect to early progression and response of patients with non-small cell lung cancer (NSCLC) metastatic to the brain, who have progressed after chemotherapy, surgery and/or radiation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California Davis Cancer Center UC Davis Cancer (3)
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute SC
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University/Wertz Clinical Cancer Center Div. of Hematology/Oncology
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • St Louis University Cancer Center
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine-Siteman Cancer Ctr
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center Oncology
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10022
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10032
        • Columbia University Medical Center New York Presbyterian
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center Dept. of DUMC (3)
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • World Health Organization (WHO) performance status of 0, 1 or 2 (corresponding to Karnofsky performance status of 50 or better)
  • Patients with radiologically proven (by gadolinium-enhanced [Gd-] magnetic resonance imaging [MRI]) parenchymal brain metastases from histologically confirmed non-small cell lung cancer (the primary disease may be quiescent). Gd-MRI must be performed within 2 weeks of study entry.
  • Patients should have at least one bidimensionally measurable intracranial lesion of a minimum of 2 cm as defined by Gd-MRI. If the patient has had previous radiation to the marker lesion(s), there must be evidence of residual disease > 2 cm or the lesion must have demonstrated progression since the radiation.
  • Those patients progressing on radiotherapy must have a 25% increase in the size of the previously radiated intracranial lesion based on the Neuro-Oncology Criteria of Tumor Response for Central Nervous System (CNS) Tumors or appearance of new lesions.
  • Patients must be controlled on medication and neurologically stable: stable on steroids and anticonvulsants for at least 2 weeks prior to obtaining the baseline Gd-MRI of the brain, and/or at least 2 weeks prior to beginning study treatment.
  • Female patients must have a negative serum pregnancy test at screening. (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal.)
  • All patients of reproductive potential must agree to use an effective method of contraception during the study and for three months following termination of treatment.
  • Written informed consent must be obtained.

Exclusion Criteria:

  • Clinical evidence of leptomeningeal disease
  • Patients with extracranial disease in more than 3 organ sites including the primary tumor.
  • Patients who have received any investigational compound within the past 28 days or who are planning to receive other investigational drugs while participating in the study
  • Prior administration of epothilone(s)
  • Patients with peripheral neuropathy > grade 1
  • Patients with unresolved diarrhea within the last 7 days before treatment.
  • Patients receiving known diarrheogenic agents must stop treatment with these agents prior to enrollment in the study.
  • Radiotherapy < 3 weeks prior to study entry
  • Prior intracranial surgery < 3 weeks prior to study entry; patient must have recovered from surgery prior to study entry.
  • Chemotherapy < 3 weeks prior to study entry; < 6 weeks from prior nitrosoureas.
  • Severe cardiac insufficiency (New York Heart Association [NYHA] III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease
  • Radiotherapy not permitted while on study. Exception: palliative radiotherapy of metastasis in extremities is allowed, but such lesions cannot be used as target or non-target lesions.
  • Patients receiving hematopoietic growth factors except for erythropoietin
  • Patients taking Coumadin® or other agents containing warfarin, with the exception of low dose Coumadin® (1 mg or less daily) administered prophylactically for maintenance of in-dwelling lines or ports

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm
Drug: Patupilone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: throughout the study
throughout the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to progression of the brain metastases
Time Frame: throughout the study
throughout the study
Pharmacokinetics (PK) of patupilone in blood
Time Frame: throughout the study
throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2005

Primary Completion (Actual)

June 24, 2010

Study Completion (Actual)

June 24, 2010

Study Registration Dates

First Submitted

September 21, 2005

First Submitted That Met QC Criteria

September 21, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEPO906A2227

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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