A Phase II Multi-center Pilot Study of Concurrent Temozolomide and Whole Brain Irradiation in Lung Cancer and Breast Cancer Patients With Brain Metastases

Phase 2

• Conditions: Lung Cancer and Breast Cancer Patients With Brain Metastases
• Interventions: Drug: temozolomide 100mg

• Registration Number: NCT02133677
• Lead Sponsor: Far Eastern Memorial Hospital

Brief Summary

Brain metastasis (BM) is among the most feared complications in cancer because even small tumors may cause incapacitating neurologic symptoms. It is observed in more than 50% of patients with lung cancer and 15% to 25% of patients with breast cancer. Temozolomide (TMZ) is an oral alkylating agent that crosses blood-brain barrier (BBB). This pilot study aims to evaluate the efficacy, safety and tolerability of whole-brain radiotherapy (WBRT) plus concomitant TMZ in lung cancer and breast cancer patients with BM.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-02
• Study First Submitted: 2014-02-05
• Study Start: 2014-05
• Study First Submitted QC: 2014-05-06
• Last Update Submitted: 2014-05-06
• Study First Posted: 2014-05-08
• Last Update Posted: 2014-05-08
• Primary Completion: 2015-05
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Histologically or cytologically confirmed lung cancer or breast cancer at primary site
• Patient with inoperable brain metastases
• Female or male, ≥ 20 and < 65 years of age
• Karnofsky performance status (KPS) ≥ 70%
• Life expectancy ≥ 12 weeks
• Adequate organ function
• Willing and able to provide a written informed consent

Exclusion Criteria

• Female of childbearing potential* who is pregnant/lactating or planning to be pregnant
• Male whose partner is planning to be pregnant
• Inability to swallow
• Meningeal carcinomatosis
• History of hypersensitivity to iodinated contrast media, temozolomide or any component of the study drugs
• Prior use of temozolomide
• Use of systemic chemotherapy within 2 weeks prior to the initiation of study treatment
• Prior surgery, chemotherapy or radiotherapy for a brain neoplasm
• Current use of valproic acid
• Use of any investigational product within 4 weeks prior to the initiation of study treatment
• Patient with any condition or disease which is considered not suitable for this study by investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
temozolomide+WBRT	temozolomide 100mg	temozolomide: TMZ 200 mg p.o. q.d. x 5 days per week x 3 weeks WBRT:30 Gy in 15 fractions (2 Gy per fraction, 5 fractions per week)

Primary Outcome Measures

Name	Time	Method
objective response rate (ORR)	assessments will be conducted between 10 to 14 weeks after the end of treatment, all subjects will be followed every 3 months since Month 6 until completion of study (12 months after the last patient is enrolled) or death, whichever comes first.	To evaluate the objective response rate (ORR) of WBRT plus concomitant TMZ treatment in lung cancer and breast cancer patients with BM.

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	assessments will be conducted between 10 to 14 weeks after the end of treatment, all subjects will be followed every 3 months since Month 6 until completion of study (12 months after the last patient is enrolled) or death, whichever comes first.	Progression free survival (PFS), Overall survival (OS), Change from baseline in MMSE scores, Change from baseline in SF-36

Trial Locations

Locations (1)

Far Eastern Memorial Hospital; 🇨🇳 New Taipei City, Taiwan