Clinical trial NCT00219297: Study of Patupilone in Patients With Brain Metastasis From Non-small Cell Lung Cancer
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain Metastasis
Non-small Cell Lung Cancer
Keywords: EPO
EPO906
Brain cancer
Brain metastasis
Lung cancer
Lung metastasis
Brain metastasis from non-small cell lung cancer
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: throughout the study
Secondary outcomes:
measure: Time to progression of the brain metastases
timeFrame: throughout the study
measure: Pharmacokinetics (PK) of patupilone in blood
timeFrame: throughout the study
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Cancer Center UC Davis Cancer (3)
state: California
city: Boston
country: United States
facility: Dana Farber Cancer Institute SC
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University/Wertz Clinical Cancer Center Div. of Hematology/Oncology
state: Michigan
city: Saint Louis
country: United States
facility: St Louis University Cancer Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine-Siteman Cancer Ctr
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center Oncology
state: New Hampshire
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center New York Presbyterian
state: New York
city: Durham
country: United States
facility: Duke University Medical Center Dept. of DUMC (3)
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: