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

Phase 2

Completed

• Conditions: Brain Metastasis; Non-small Cell Lung Cancer
• Interventions: Drug: Patupilone

• Registration Number: NCT00219297
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-21
• Study First Submitted QC: 2005-09-21
• Study First Posted: 2005-09-22
• Study Start: 2005-11-16
• Primary Completion: 2010-06-24
• Study Completion: 2010-06-24
• Disposition First Submitted: 2012-05-01
• Disposition First Submitted QC: 2012-05-01
• Disposition First Posted: 2012-05-03
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Patupilone	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (12)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

University of California Davis Cancer Center UC Davis Cancer (3); 🇺🇸 Sacramento, California, United States

Wayne State University/Wertz Clinical Cancer Center Div. of Hematology/Oncology; 🇺🇸 Detroit, Michigan, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Dana Farber Cancer Institute SC; 🇺🇸 Boston, Massachusetts, United States

Washington University School of Medicine-Siteman Cancer Ctr; 🇺🇸 Saint Louis, Missouri, United States

Dartmouth Hitchcock Medical Center Oncology; 🇺🇸 Lebanon, New Hampshire, United States

University of Wisconsin Hospital and Clinics; 🇺🇸 Madison, Wisconsin, United States

Duke University Medical Center Dept. of DUMC (3); 🇺🇸 Durham, North Carolina, United States

Columbia University Medical Center New York Presbyterian; 🇺🇸 New York, New York, United States

St Louis University Cancer Center; 🇺🇸 Saint Louis, Missouri, United States