Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-26 @ 9:59 PM
Study NCT ID:
NCT00732303
Status:
TERMINATED
Last Update Posted:
2016-04-27
First Post:
2008-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pemetrexed and Radiation for Poor-Risk Stage III Non-Small Cell Lung Cancer
Sponsor:
Hoosier Cancer Research Network
Organization:
Study Overview
Official Title:
A Phase II Study of Concurrent Pemetrexed and Radiation for Poor-Risk Stage III Non-Small Cell Lung Cancer: Hoosier Oncology Group LUN08-129
Status:
TERMINATED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated due to withdrawal of pharmaceutical funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pemetrexed is approved for second line therapy in metastatic NSCLC. Given the single-agent activity of pemetrexed and the tolerability of pemetrexed in combination with radiation, this study will evaluate survival rates and toxicities in patients with poor risk stage III NSCLC.
Detailed Description:
OUTLINE: This is a multi-center study.
* Pemetrexed (Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles
* Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.
The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.
Performance Status: ECOG performance status 2
Life Expectancy: Not specified
Hematopoietic:
* Platelets ≥ 100 K/mm3
* Absolute Neutrophil Count (ANC) ≥ 2.0 K/mm3
Hepatic:
* Aspartate transaminase (AST) ≤ 2.5 x ULN.
* Alanine transaminase (ALT) ≤ 2.5 x ULN.
* Total bilirubin ≤ 1.5 x ULN
Renal:
* Calculated creatinine clearance (using Cockcroft-Gault formula) ≥ 45 cc/min
Cardiovascular:
* No significant history of cardiac disease. Must not have unstable angina (anginal symptoms at rest).
Pulmonary:
* Forced expiratory volume in 1 second (FEV1) greater than 1L
* Pemetrexed (Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles
* Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.
The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.
Performance Status: ECOG performance status 2
Life Expectancy: Not specified
Hematopoietic:
* Platelets ≥ 100 K/mm3
* Absolute Neutrophil Count (ANC) ≥ 2.0 K/mm3
Hepatic:
* Aspartate transaminase (AST) ≤ 2.5 x ULN.
* Alanine transaminase (ALT) ≤ 2.5 x ULN.
* Total bilirubin ≤ 1.5 x ULN
Renal:
* Calculated creatinine clearance (using Cockcroft-Gault formula) ≥ 45 cc/min
Cardiovascular:
* No significant history of cardiac disease. Must not have unstable angina (anginal symptoms at rest).
Pulmonary:
* Forced expiratory volume in 1 second (FEV1) greater than 1L
Study Oversight
Has Oversight DMC:
True
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?: