Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216216
Status:
TERMINATED
Last Update Posted:
2011-05-02
First Post:
2005-09-12
Brief Title:
Pemetrexed in Patients With Chemosensitive and Chemoresistant Relapsed Small Cell Lung Cancer
Sponsor:
Hoosier Cancer Research Network
Organization:
Hoosier Cancer Research Network
Study Overview
Official Title:
Pemetrexed Alimta in Patients With Chemosensitive and Chemoresistant Relapsed Small Cell Lung Cancer A Hoosier Oncology Group Phase II Study LUN04-78
Status:
TERMINATED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The results from the interim analysis were not favorable to continue this trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with relapsed or chemotherapy-refractory SCLC have a dismal prognosis Unfortunately available treatments result in few durable responses Pemetrexed is a well-tolerated agent which is active in NSCLC Since chemotherapy agents which are active in NSCLC are usually also active in SCLC this trial will examine the efficacy and activity of pemetrexed in this palliative setting
Detailed Description:
OUTLINE This is a multi-center study
Pemetrexed 500 mgm2 iv q 3 wks
All patients will also receive folic acid 350-1000 mcg po once daily beginning approximately 1 week prior to the first dose of pemetrexed and continuing until completion of pemetrexed Vitamin B12 1000 mcg IM every 9 weeks beginning approximately 1 week prior to the first dose of pemetrexed and continuing until completion of pemetrexed and dexamethasone 4 mg po bid the day before the day of and the day following each treatment with pemetrexed
Chest x-ray will be performed prior to each cycle if other disease assessment by imaging is not performed in order to ensure patients are not rapidly progressing
Cycles are repeated every 3 weeks for up to 6 cycles or PD or intolerable side effects
Performance Status ECOG 0 1 or 2
Life Expectancy Not specified
Hematopoietic
WBC 3000mm3
ANC 1500mm3
Platelet count 100000mm3
Hemoglobin 8 gdL
Hepatic
Bilirubin 10 X upper limit of normal
Aspartate aminotransferase AST SGOT 25 x upper limit of normal AST may be 5 x upper limit of normal for patients with liver metastasis
Renal
Creatinine clearance of 45 ml min by Cockcroft-Gault
Cardiovascular
No unstable or uncompensated cardiovascular conditions
Pulmonary
No unstable or uncompensated respiratory conditions
Pemetrexed 500 mgm2 iv q 3 wks
All patients will also receive folic acid 350-1000 mcg po once daily beginning approximately 1 week prior to the first dose of pemetrexed and continuing until completion of pemetrexed Vitamin B12 1000 mcg IM every 9 weeks beginning approximately 1 week prior to the first dose of pemetrexed and continuing until completion of pemetrexed and dexamethasone 4 mg po bid the day before the day of and the day following each treatment with pemetrexed
Chest x-ray will be performed prior to each cycle if other disease assessment by imaging is not performed in order to ensure patients are not rapidly progressing
Cycles are repeated every 3 weeks for up to 6 cycles or PD or intolerable side effects
Performance Status ECOG 0 1 or 2
Life Expectancy Not specified
Hematopoietic
WBC 3000mm3
ANC 1500mm3
Platelet count 100000mm3
Hemoglobin 8 gdL
Hepatic
Bilirubin 10 X upper limit of normal
Aspartate aminotransferase AST SGOT 25 x upper limit of normal AST may be 5 x upper limit of normal for patients with liver metastasis
Renal
Creatinine clearance of 45 ml min by Cockcroft-Gault
Cardiovascular
No unstable or uncompensated cardiovascular conditions
Pulmonary
No unstable or uncompensated respiratory conditions
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