CompletedPhase 2NCT00219297

Study of Patupilone in Patients With Brain Metastasis From 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.

Checked against the public recordLast updated Feb 21, 2021 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations12
SponsorNovartis Pharmaceuticals
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Novartis Pharmaceuticals
Interventions being studied
Drug: Patupilone
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of California Davis Cancer Center UC Davis Cancer (3)Sacramento, California
  • Dana Farber Cancer Institute SCBoston, Massachusetts
  • Wayne State University/Wertz Clinical Cancer Center Div. of Hematology/OncologyDetroit, Michigan
  • St Louis University Cancer CenterSt Louis, Missouri
  • Washington University School of Medicine-Siteman Cancer CtrSt Louis, Missouri
  • Dartmouth Hitchcock Medical Center OncologyLebanon, New Hampshire
  • Roswell Park Cancer InstituteBuffalo, New York
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • Columbia University Medical Center New York PresbyterianNew York, New York
  • Duke University Medical Center Dept. of DUMC (3)Durham, North Carolina
  • Cleveland Clinic FoundationCleveland, Ohio
  • University of Wisconsin Hospital and ClinicsMadison, Wisconsin

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 21, 2021. Always confirm current availability with the study team.

View original record ↗