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

Primary Purpose

Lung Cancer and Breast Cancer Patients With Brain Metastases

Status

Unknown status

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

temozolomide 100mg

About this trial

This is an interventional treatment trial for Lung Cancer and Breast Cancer Patients With Brain Metastases focused on measuring lung cancer and breast cancer patients with brain metastases

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Far Eastern Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

temozolomide+WBRT

Arm Description

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)

Outcomes

Primary Outcome Measures

objective response rate (ORR)

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

Progression free survival (PFS)

Progression free survival (PFS), Overall survival (OS), Change from baseline in MMSE scores, Change from baseline in SF-36

Full Information

NCT ID

NCT02133677

First Posted

February 5, 2014

Last Updated

May 6, 2014

Sponsor

Far Eastern Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02133677

Brief Title

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

Official Title

A Phase II, Open-label, Single-arm, Multi-center Pilot Study to Evaluate the Efficacy and Safety of Whole-brain Radiotherapy With Concomitant Temozolomide in Lung Cancer and Breast Cancer Patients With Brain Metastases

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Unknown status

Study Start Date

May 2014 (undefined)

Primary Completion Date

May 2015 (Anticipated)

Study Completion Date

May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Far Eastern Memorial Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer and Breast Cancer Patients With Brain Metastases

Keywords

lung cancer and breast cancer patients with brain metastases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

temozolomide+WBRT

Arm Type

Experimental

Arm Description

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)

Intervention Type

Drug

Intervention Name(s)

temozolomide 100mg

Other Intervention Name(s)

Tamos 100mg capsule

Intervention Description

WBRT: 30 Gy in 15 fractions (2 Gy per fraction, 5 fractions per week) CT: TMZ 200 mg p.o. q.d. x 5 days per week x 3 weeks

Primary Outcome Measure Information:

Title

objective response rate (ORR)

Description

To evaluate the objective response rate (ORR) of WBRT plus concomitant TMZ treatment in lung cancer and breast cancer patients with BM.

Time Frame

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.

Secondary Outcome Measure Information:

Title

Progression free survival (PFS)

Description

Progression free survival (PFS), Overall survival (OS), Change from baseline in MMSE scores, Change from baseline in SF-36

Time Frame

Other Pre-specified Outcome Measures:

Title

Safety

Description

Change in lab data Adverse event(s) (AE) Serious adverse event(s) (SAE)

Time Frame

safety of study treatments will be assessed by physician at each return. The safety for individual subject will be followed till 2 weeks after EOT.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pei-Wei Shueng, MD

Phone

886-2-8966-7000

Ext

1022

shueng@mail.femh.org.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pei-Wei Shueng, MD

Organizational Affiliation

Chief, Department of Radiation Oncology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Far Eastern Memorial Hospital

City

New Taipei City

ZIP/Postal Code

220

Country

Taiwan

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pei-Wei Shueng, MD

Phone

886-2-8966-7000

Ext

1022

shueng@mail.femh.org.tw

First Name & Middle Initial & Last Name & Degree

Pei-Wei Shueng, MD

12. IPD Sharing Statement

Learn more about this trial

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

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