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

A Phase I Study of Premetrexed (Alimta) and Carboplatin and Radiation Therapy in Patients With Inoperable Non Small Cell Lung Cancer.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00330044

Enrollment

Registered

2006-05-25

Start date

2006-04-30

Completion date

2009-10-31

Last updated

2025-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inoperable Non Small Cell Lung Cancer

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.

Interventions

DRUGPremetrexed (Alimta)

DRUGCarboplatin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Response and Progression Free Survival	Up to five years after study completion

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026