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
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Novartis Pharmaceuticals
- Interventions being studied
- Drug: Patupilone
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
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.