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

Eli Lilly and Company49 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Small Cell Lung Cancer

Interventions

Pemetrexed Phase 1DRUG

300 mg/m\^2 IV, Days 1 and 22; intermediate dose escalation level of 400 mg/m\^2 IV; then 500 mg/m\^2 IV, repeated every 21 days (q 21 days) x 2 cycles

Cisplatin Phase 1DRUG

Cohorts 1-3: 25 mg/m\^2 IV, Days 1-3 and 22-24 then 75 mg/m\^2 IV, q21 days x 2 cycles Cohort 4 carried into Phase 2: 20 mg/m\^2 IV, Days 1-5 and 22-26 then 75 mg/m\^2 IV, q21 days x 2 cycles.

Radiation TherapyPROCEDURE

Phases 1 and 2: 61-65 Gy in 33-35 fractions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Edmonton, Alberta, Canada

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

Phase 1: Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cisplatin and Radiation Therapy

Recommended Phase 2 MTD was highest dose at which no more than 1 of 6 participants experienced dose level toxicity (DLT). DLT=(1) Grade 3/4 dysphagia/esophagitis, leukopenia, thrombocytopenia, febrile neutropenia, fatigue/malaise, pneumonitis, dermatitis, persistent elevation of bilirubin/alkaline phosphatase/aspartate aminotransferase only if resulting in delay of radiotherapy \>1 week, delay of pemetrexed/cisplatin Cycle 2 \>2 weeks, or delay of pemetrexed/cisplatin Cycle 3 past 5 weeks after radiotherapy; (2) other Grade 3 or 4 toxicity possibly related to concurrent treatment administration.

Time frame: Baseline to measured progressive disease (PD; up to 1 year)

Phase 2: Percentage of Participants With Overall Survival (OS) at 1 Year

OS was defined as the time from date of enrollment to death due to any cause.

Time frame: Baseline to date of death from any cause (up to 1 year)

Secondary Outcomes

Phase 1: Number of Participants With Adverse Events (AE; Toxicity)

A listing of AEs is located in the Reported Adverse Event module.

Time frame: Baseline to measured PD (up to 1 year)

Phase 2: Percentage of Participants With Overall Survival (OS) at 2 Years and 3 Years

OS was defined as the time from date of enrollment to death due to any cause.

Time frame: Baseline and 2 years and 3 years

Phase 2: Time to Progressive Disease (PD)

Time to PD was defined as the time from study enrollment to the first date of objective disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as at least a 20% increase in the sum of the longest diameter (LD) of target lesions as references the smallest sum LD recorded since treatment started or the appearance of 1 or more new lesions. Time to PD was censored at the date of death if death was due to other cause. For participants not known to have died as of the data cut-off date and who did not have PD, time to PD was censored at the last progression-free disease assessment. For participants who received subsequent cancer therapy (after discontinuation from the study therapy) before PD, time to PD was censored at the date of subsequent cancer therapy initiation.

Data from ClinicalTrials.gov

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