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

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status and phase: Completed; Phase 1

Conditions: Inoperable Non Small Cell Lung Cancer

Treatments: Drug: Premetrexed (Alimta); Drug: Carboplatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00330044

05C.276

JT 1070 (Other Identifier)

2005-19 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Drug

Experimental group

Description:

Carboplatin and Pemetrexed

Treatment:

Drug: Carboplatin

Drug: Premetrexed (Alimta)