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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00219297

Collaborator

(none)

Enrollment

Locations

Arm

55.2

Actual Duration (Months)

4.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Metastasis Non-small Cell Lung Cancer	Drug: Patupilone	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Nov 16, 2005

Actual Primary Completion Date :

Jun 24, 2010

Actual Study Completion Date :

Jun 24, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Arm	Drug: Patupilone

Arm

Intervention/Treatment

Experimental: Single Arm

Drug: Patupilone

Outcome Measures

Primary Outcome Measures

Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST) [throughout the study]

Secondary Outcome Measures

Time to progression of the brain metastases [throughout the study]
Pharmacokinetics (PK) of patupilone in blood [throughout the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

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