Study of Temozolomide in the Treatment of Brain Metastasis From Non-small-cell Lung Cancer (Study P02143)

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Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

temozolomide

About this trial

This is an interventional treatment trial for Metastases, Neoplasm focused on measuring Brain mets, non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologic confirmation of non-small-cell lung cancer Stable systemic disease Maximum of one prior chemotherapy regimen for metastatic systemic disease Radiotherapy for local control or palliative bony lesions is allowed Karnofsky of greater than or equal to 70% Adequate hematologic, renal and liver function Exclusion Criteria: Patients eligible for surgery of the brain Any previous chemotherapy for the brain metastasis Chemotherapy within 4 weeks or previous temozolomide Prior radiotherapy to the brain Radiation therapy to greater than 50% of the bone marrow Insufficient recovery from previous therapies Active nonmalignant systemic disease Inability to take oral medication Pregnant or nursing women Non use of adequate contraceptive techniques, negative urine pregnancy test is required Known AIDS related illness

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00034697

First Posted

May 1, 2002

Last Updated

May 22, 2017

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00034697

Brief Title

Study of Temozolomide in the Treatment of Brain Metastasis From Non-small-cell Lung Cancer (Study P02143)

Official Title

A Phase II Study of Temozolomide (SCH 52365) in Subjects With Brain Metastasis From Non-Small-Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Terminated

Why Stopped

Slow Enrollment

Study Start Date

June 28, 2001 (Actual)

Primary Completion Date

January 30, 2003 (Actual)

Study Completion Date

January 30, 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

Brief Summary

Brain metastases from solid tumors are diagnosed in more than 300,000 patients annually. Nonsmall cell lung cancer accounts for the majority of CNS mets. Treatment with whole brain radiation and steroids will improve neurologic symptoms in about 50% of patients although survival is short. This study will test the safety and efficacy of temozolomide in combination with radiation therapy in the treatment of patients with brain mets form nonsmall cell lung cancer.

6. Conditions and Keywords

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

Metastases, Neoplasm, Carcinoma, Non-Small-Cell Lung, Brain Neoplasms

Keywords

Brain mets, non-small cell lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

temozolomide

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Histologic confirmation of non-small-cell lung cancer Stable systemic disease Maximum of one prior chemotherapy regimen for metastatic systemic disease Radiotherapy for local control or palliative bony lesions is allowed Karnofsky of greater than or equal to 70% Adequate hematologic, renal and liver function Exclusion Criteria: Patients eligible for surgery of the brain Any previous chemotherapy for the brain metastasis Chemotherapy within 4 weeks or previous temozolomide Prior radiotherapy to the brain Radiation therapy to greater than 50% of the bone marrow Insufficient recovery from previous therapies Active nonmalignant systemic disease Inability to take oral medication Pregnant or nursing women Non use of adequate contraceptive techniques, negative urine pregnancy test is required Known AIDS related illness

12. IPD Sharing Statement

Available IPD and Supporting Information:

Available IPD/Information Type

CSR Synopsis Links

Available IPD/Information URL

http://www.merck.com/clinical-trials/policies-perspectives.html

Metastases, Neoplasm, Carcinoma, Non-Small-Cell Lung, Brain Neoplasms

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial