NCT00219297

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2005

Typical duration for phase_2

Geographic Reach
1 country

12 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

First Submitted

Initial submission to the registry

September 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

November 16, 2005

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2010

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

4.6 years

First QC Date

September 21, 2005

Last Update Submit

February 17, 2021

Conditions

Brain MetastasisNon-small Cell Lung Cancer

Keywords

EPOEPO906Brain cancerBrain metastasisLung cancerLung metastasisBrain metastasis from non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)

    throughout the study

Secondary Outcomes (2)

  • Time to progression of the brain metastases

    throughout the study

  • Pharmacokinetics (PK) of patupilone in blood

    throughout the study

Study Arms (1)

Single Arm

EXPERIMENTAL
Drug: Patupilone

Interventions

PatupiloneDRUG
Single Arm

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University of California Davis Cancer Center UC Davis Cancer (3)

Sacramento, California, 95817, United States

Location

Dana Farber Cancer Institute SC

Boston, Massachusetts, 02115, United States

Location

Wayne State University/Wertz Clinical Cancer Center Div. of Hematology/Oncology

Detroit, Michigan, 48201, United States

Location

St Louis University Cancer Center

St Louis, Missouri, 63110, United States

Location

Washington University School of Medicine-Siteman Cancer Ctr

St Louis, Missouri, 63110, United States

Location

Dartmouth Hitchcock Medical Center Oncology

Lebanon, New Hampshire, 03756, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10022, United States

Location

Columbia University Medical Center New York Presbyterian

New York, New York, 10032, United States

Location

Duke University Medical Center Dept. of DUMC (3)

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Links

MeSH Terms

Conditions

Brain NeoplasmsCarcinoma, Non-Small-Cell LungLung Neoplasms

Interventions

epothilone B

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCarcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 21, 2005

First Posted

September 22, 2005

Study Start

November 16, 2005

Primary Completion

June 24, 2010

Study Completion

June 24, 2010

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

US(12)