NCT00732303

Pemetrexed and Radiation for Poor-Risk Stage III Non-Small Cell Lung Cancer

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Hoosier Cancer Research Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Pemetrexed	Pemetrexed (Alimta) 500mg/\^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles
RADIATION	Radiation Therapy	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.

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-08-11
• Last updated: 2016-04-27
• Results posted: 2016-04-27

Locations

18 sites across 1 country: United States