Alimta, Carboplatin and Radiation Therapy for Non Small Cell Lung Cancer

Phase 1

Completed

• Conditions: Inoperable Non Small Cell Lung Cancer
• Interventions: Drug: Premetrexed (Alimta); Drug: Carboplatin

• Registration Number: NCT00330044
• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Brief Summary

To determine the safety of Alimta when used with chemoradiation in inoperable non small cell lung cancer

Detailed Description

To determine the maximal tolerated dose (MTD) and toxicities of Pemetrexed (Alimta) when administered concurrently with carboplatin and thoracic radiation therapy.

To determine, qualitatively, the occurrence of local tumor responses identified with this regimen.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-05-24
• Study First Submitted QC: 2006-05-24
• Study First Posted: 2006-05-25
• Primary Completion: 2009-08
• Study Completion: 2009-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Unresectable Stage II, IIIB or IV non small cell lung cancer. Evaluable disease on planning CT scan Zubrod 0-1 Weight loss equal to or less than 10% 3 months prior to diagnosis FEV1 greater than 1000cc Adequate hematologic, renal and hepatic functions

Exclusion Criteria

• Small cell cancer Stage I non small cell cancer Prior chemotherapy or thoracic or lower neck radiatio therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drug	Premetrexed (Alimta)	Carboplatin and Pemetrexed
Drug	Carboplatin	Carboplatin and Pemetrexed

Primary Outcome Measures

Name	Time	Method
Response and Progression Free Survival	Up to five years after study completion

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States