Everolimus and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastasis From Non-Small Cell Lung Cancer

Phase 1

Terminated

• Conditions: Lung Cancer; Metastatic Cancer
• Interventions: Drug: RAD001; Radiation: whole-brain radiation therapy

• Registration Number: NCT00892801
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief Summary

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving everolimus together with whole-brain radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus and to see how well it works when given together with whole-brain radiation therapy in treating patients with brain metastasis from non-small cell lung cancer.

Detailed Description

Phase I is intended to determine the maximum tolerated dose. Study drug will be administered orally, once a day, for 15 days, one day prior to initiation of WBRT at 5 or 10 mg/day during the phase I component. One of these doses will be selected as the maximum tolerable dose and will be selected for the phase II component.

OBJECTIVES:

Primary

* To determine the maximum-tolerated dose of everolimus when combined concurrently with whole-brain radiotherapy in patients with brain metastasis from stage IV non-small cell lung cancer. (Phase I)

* To evaluate the median survival of these patients treated with this regimen. (Phase II)

Secondary

* To assess the response rates in these patients. (Phase II)

* To assess the safety and tolerability of this regimen in these patients. (Phase II)

* To determine time to CNS (neurological) progression, confirmed by MRI, in these patients. (Phase II)

* To determine time to systemic (non-CNS) progression in these patients. (Phase II)

OUTLINE: This is a multicenter, dose-escalation study of everolimus.

Patients undergo 10 fractions of whole-brain radiotherapy (WBRT) beginning on day 0, 5 days per week, and receive oral everolimus once daily on days -1 to 13. Beginning 2 weeks after completion of WBRT, patients receive oral everolimus once daily for 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 2 months for 2 years.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-02
• Study First Submitted QC: 2009-05-02
• Study First Posted: 2009-05-05
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-09
• Last Update Posted: 2012-03-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	RAD001	RAD001 + radiation therapy
Treatment	whole-brain radiation therapy	RAD001 + radiation therapy

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose	4 week DLT period	Safety is measured by the rate of ≥ grade 3 hematological and non-hematologic study-related toxicities.
Median survival (phase II)	Off-study date.

Secondary Outcome Measures

Name	Time	Method
Intracranial response rate (phase II)	Off-treatment date.
Time to CNS (neurologic) progression (phase II)	Off-treatment date.
Time to systemic non-CNS progression (phase II)	Off-treatment date

Trial Locations

Locations (2)

Vanderbilt-Ingram Cancer Center - Cool Springs; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States