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

Non-small Cell Lung Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00219297
• Other study ID #: CEPO906A2227
• Status: Completed
• Phase: Phase 2
• Start date: November 16, 2005
• Est. completion date: June 24, 2010

Study information

• Verified date: February 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 24, 2010
• Est. primary completion date: June 24, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastasis
• Brain Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Non-small Cell Lung Cancer

Intervention

Drug:
• Patupilone

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute SC	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Wayne State University/Wertz Clinical Cancer Center Div. of Hematology/Oncology	Detroit	Michigan
United States	Duke University Medical Center Dept. of DUMC (3)	Durham	North Carolina
United States	Dartmouth Hitchcock Medical Center Oncology	Lebanon	New Hampshire
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	Columbia University Medical Center New York Presbyterian	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	University of California Davis Cancer Center UC Davis Cancer (3)	Sacramento	California
United States	St Louis University Cancer Center	Saint Louis	Missouri
United States	Washington University School of Medicine-Siteman Cancer Ctr	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)		throughout the study
Secondary	Time to progression of the brain metastases		throughout the study
Secondary	Pharmacokinetics (PK) of patupilone in blood		throughout the study

External Links

•   Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.