Concurrent Pemetrexed, Cisplatin and Radiation Therapy in Patients With Stage IIIA/B Non Small Cell Lung Cancer

Lilly

Status and phase: Completed; Phase 2; Phase 1

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Pemetrexed Phase 1; Procedure: Radiation Therapy; Drug: Cisplatin Phase 1; Drug: Pemetrexed Phase 2; Drug: Cisplatin Phase 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT00529100

H3E-CA-JMHU (Other Identifier)

10259

Details and patient eligibility

About

Measure the 1 year survival of non small cell lung cancer (NSCLC) patients who are being treated with pemetrexed in combination with cisplatin and radiation.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Some of the requirements to be in this study are:

• Patient must be at least 18 years old.
• Patient must have been diagnosed with non-small cell lung cancer.
• Patient must be able to visit the doctor's office once a week.
• Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.
• Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.

Exclusion criteria

Patients cannot participate in this study for any of the following reasons:

• Patient has previously had chemotherapy.
• Patient has previously had thoracic radiation therapy.
• Patient has received treatment within the last 30 days with a drug that has not received approval by Health Canada for any indication at the time of study entry.
• Female patient is pregnant or breast-feeding.
• Patient is unsuitable to participate in the study in the opinion of the investigator.
• Patient is unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Pemetrexed/Cisplatin/Radiation Phase 1

Experimental group

Description:

Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m\^2) IV through 500 mg/m\^2 IV on Days 1 and 22; concurrent cisplatin 25 mg/m\^2 IV on Days 1-3 and 22-24 for Cohorts 1-3 and cisplatin 20 mg/m\^2 IV on Days 1-5 and 22-26 for Cohort 4. Participants then received 2 additional consolidation cycles repeated every 3 weeks (q3 weeks) of pemetrexed 500 mg/m\^2 IV and cisplatin 75 mg/m\^2 IV.

Treatment:

Drug: Cisplatin Phase 1

Procedure: Radiation Therapy

Drug: Pemetrexed Phase 1

Pemetrexed/Cisplatin/Radiation Phase 2

Experimental group

Description:

Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent phase pemetrexed IV bolus as determined by Phase 1 trial to be 500 mg/m\^2 IV on Days 1 and 22 ; concurrent cisplatin 20 mg/m\^2 IV as determined by Phase 1 trial with cycles commencing on Days 1 and 22; 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m\^2 IV and cisplatin 75 mg/m\^2 IV.

Treatment:

Drug: Pemetrexed Phase 2

Drug: Cisplatin Phase 2

Procedure: Radiation Therapy