Clinical trial NCT00529100: Concurrent Pemetrexed, Cisplatin and Radiation Therapy in Patients With Stage IIIA/B Non Small Cell Lung Cancer
Official title: A Phase I/II Study of Concurrent Pemetrexed/Cisplatin/Radiation in Stage IIIA/B Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-09-14
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Phase 1: Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cisplatin and Radiation Therapy
timeFrame: Baseline to measured progressive disease (PD; up to 1 year)
measure: Phase 2: Percentage of Participants With Overall Survival (OS) at 1 Year
timeFrame: Baseline to date of death from any cause (up to 1 year)
Secondary outcomes:
measure: Phase 1: Number of Participants With Adverse Events (AE; Toxicity)
timeFrame: Baseline to measured PD (up to 1 year)
measure: Phase 2: Percentage of Participants With Overall Survival (OS) at 2 Years and 3 Years
timeFrame: Baseline and 2 years and 3 years
measure: Phase 2: Time to Progressive Disease (PD)
timeFrame: Baseline to measured PD (up to 3 years)
measure: Phase 2: Percentage of Participants With Progression Free Survival (PFS)
timeFrame: Baseline and 1 year and 2 years and 3 years
measure: Progression Free Survival (PFS)
timeFrame: Baseline to measured PD (up to 36 months)
measure: Phase 2: Percentage of Participants With Objective Tumor Response (Response Rate)
timeFrame: Baseline to measured PD (up to 3 years)
measure: Phase 2: Site of Progressive Disease (PD)
timeFrame: Baseline to measured PD (up to 3 years)
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: 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.
state: Alberta
city: Hamilton
country: Canada
facility: 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.
state: Ontario
city: Ottawa
country: Canada
facility: 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.
state: Ontario
city: Toronto
country: Canada
facility: 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.
state: Ontario
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT- 5 hours, EST)
role: STUDY_DIRECTOR
References: