Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003062
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
1999-11-01
Brief Title:
Temozolomide in Patients With Progressive or Recurrent Non-small Cell Lung Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Phase II Study of TEMOZOLOMIDE in Advanced Non-Small Cell Lung Cancer With and Without Brain Metastases
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effect of temozolomide in patients with progressive or recurrent stage IV non-small cell lung cancer with or without brain metastases who have not been treated for metastatic disease with chemotherapy
PURPOSE Phase II trial to study the effect of temozolomide in patients with progressive or recurrent stage IV non-small cell lung cancer with or without brain metastases who have not been treated for metastatic disease with chemotherapy
Detailed Description:
OBJECTIVES I Assess the therapeutic activity of temozolomide TMZ in patients with non-small cell lung cancer NSCLC with or without brain metastases untreated by chemotherapy for metastatic disease II Characterize the acute side effects of temozolomide in these patients III Assess the duration of response in responding patients
OUTLINE This is an open label nonrandomized multicenter study Temozolomide is given by oral doses that are equally fractionated over 5 days and repeated every 4 weeks Patients with brain metastases Treatment is discontinued if there is progression of disease in both sites brain and nonbrain or if there is progression of disease of the brain lesion and stable disease of the other target lesions Patients with progressive disease of the brain target lesions with contemporary evidence of response in the other target lesion can receive further temozolomide in addition to nonchemotherapy medical treatment of the brain metastases steroids mannitol etc Patients with progressive disease in the other target lesions with contemporary evidence of response of the brain target lesions can receive further temozolomide therapy in addition to specific local radiotherapy of the nonbrain lesions Patients without brain metastases Treatment discontinues if there is clear cut progression occurring before the first disease evaluation 8 weeks after treatment start For stable disease the patient is treated for a minimum of 8 weeks and evaluated thereafter Treatment in most cases is for a minimum of 2 cycles and may continue for a maximum of 6 cycles in the absence of disease progression unacceptable toxicity or patient refusal All patients are followed every 6 weeks for survival
PROJECTED ACCRUAL A minimum of 24 evaluable patients and a maximum of 70 evaluable patients will be accrued for this study
OUTLINE This is an open label nonrandomized multicenter study Temozolomide is given by oral doses that are equally fractionated over 5 days and repeated every 4 weeks Patients with brain metastases Treatment is discontinued if there is progression of disease in both sites brain and nonbrain or if there is progression of disease of the brain lesion and stable disease of the other target lesions Patients with progressive disease of the brain target lesions with contemporary evidence of response in the other target lesion can receive further temozolomide in addition to nonchemotherapy medical treatment of the brain metastases steroids mannitol etc Patients with progressive disease in the other target lesions with contemporary evidence of response of the brain target lesions can receive further temozolomide therapy in addition to specific local radiotherapy of the nonbrain lesions Patients without brain metastases Treatment discontinues if there is clear cut progression occurring before the first disease evaluation 8 weeks after treatment start For stable disease the patient is treated for a minimum of 8 weeks and evaluated thereafter Treatment in most cases is for a minimum of 2 cycles and may continue for a maximum of 6 cycles in the absence of disease progression unacceptable toxicity or patient refusal All patients are followed every 6 weeks for survival
PROJECTED ACCRUAL A minimum of 24 evaluable patients and a maximum of 70 evaluable patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-08965 | None | None | None |