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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00609518




Registration number
NCT00609518
Ethics application status
Date submitted
23/01/2008
Date registered
7/02/2008
Date last updated
28/12/2010

Titles & IDs
Public title
A Study for Patients With Non-Squamous Non-Small Cell Lung Cancer
Scientific title
Pemetrexed With Simplified Folate and Dexamethasone Supplementation Versus Pemetrexed With Standard Supplementation as Second-line Chemotherapy for Patients With Non-squamous Non-small Cell Lung Cancer
Secondary ID [1] 0 0
H3E-CR-S111
Secondary ID [2] 0 0
11652
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - pemetrexed
Other interventions - Folic acid
Other interventions - Folic Acid
Other interventions - Vitamin B12
Treatment: Drugs - dexamethasone
Treatment: Drugs - dexamethasone

Active Comparator: Standard Vitamin and Steroid Schedule + Pemetrexed - Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.

Experimental: Simplified Vitamin and Steroid Schedule + Pemetrexed - Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.


Treatment: Drugs: pemetrexed
500 mg/m^2 intravenous infusion on day 1 of each 21-day cycle. Number of Cycles: Until progression or to a maximum of 6 cycles.

Other interventions: Folic acid
350-1000 micrograms taken orally for at least 5 daily doses during the 7-day period prior to the first dose of pemetrexed then continues daily throughout treatment until 3 weeks after the last dose of pemetrexed.

Other interventions: Folic Acid
350-1000 micrograms taken orally for two consecutive daily doses of folic acid the day before and the day of the first dose of pemetrexed the continues throughout treatment and for 3 weeks after the last dose of pemetrexed.

Other interventions: Vitamin B12
1000 micrograms intramuscular injection of vitamin B12 during the week prior to the first dose of pemetrexed then further injections given approximately every 9 weeks until 3 weeks after the last dose of pemetrexed.

Treatment: Drugs: dexamethasone
4 mg taken orally [or equivalent] twice per day the day before, the day of, and the day after the first day of pemetrexed. Continue to give dexamethasone twice per day the day before, the day of, and the day after each dose of pemetrexed.

Treatment: Drugs: dexamethasone
4 mg taken orally [or equivalent] twice per day on the day of the first dose of pemetrexed. Continue to give dexamethasone twice per day on the day of each dose of pemetrexed.

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety: Number of Participants With Drug-Related Grade 3 or 4 Toxicity - Results are presented for the number of participants with drug-related Grade 3 or 4 toxicity/adverse event (AE). Grades range from 0 (none) to 5 (death), with Grade 3 and 4 being defined as follows:
Grade 0 = No AE; Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. A detailed list of Serious and non-serious adverse events is provided in the Reported Adverse Event section.
Timepoint [1] 0 0
From first dose of treatment to last dose of treatment plus 30 days
Secondary outcome [1] 0 0
Proportion of Participants With Best Overall Tumor Response (Response Rate) - Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Best Overall Tumor Response is complete response plus partial response.
Timepoint [1] 0 0
Baseline until disease progression, new therapy initiated, or death from any cause, up to 12 months after enrollment.
Secondary outcome [2] 0 0
Overall Survival - Overall survival is the duration from randomization to death. For patients who are alive, overall survival is censored at the date of last contact.
Timepoint [2] 0 0
Randomization (=4 weeks from baseline visit) to 12 months after randomization
Secondary outcome [3] 0 0
Progression-free Survival (PFS) - Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. For patients who are alive and have not progressed, PFS is censored at the date of last radiological assessment.
Timepoint [3] 0 0
Randomization (=4 weeks from baseline visit) to 12 months after randomization

Eligibility
Key inclusion criteria
- Histologic or cytologic diagnosis of non-small cell lung cancer (NSCLC) with locally
advanced or metastatic disease (Stage IIIA, IIIB or IV)that is of non-squamous
histology

- Patients must have failed only one prior chemotherapy regime and must be considered
eligible for further chemotherapy following progression of their disease.

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

- Adequate organ function
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Concurrent administration of any other anti-tumor therapy

- Other co-existing malignancies

- Pregnancy or breast feeding

- Serious concomitant disorders

- Inability or unwillingness to take folic acid or vitamin B12 supplementation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
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. - Bankstown
Recruitment hospital [2] 0 0
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. - Concord
Recruitment hospital [3] 0 0
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. - Kingswood Penrith
Recruitment hospital [4] 0 0
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. - Liverpool
Recruitment hospital [5] 0 0
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. - Redcliffe
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2747 - Kingswood Penrith
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
4020 - Redcliffe
Recruitment outside Australia
Country [1] 0 0
Italy
State/province [1] 0 0
Bologna
Country [2] 0 0
Italy
State/province [2] 0 0
Milano
Country [3] 0 0
Italy
State/province [3] 0 0
Napoli
Country [4] 0 0
Italy
State/province [4] 0 0
Pisa
Country [5] 0 0
Italy
State/province [5] 0 0
Rome
Country [6] 0 0
Mexico
State/province [6] 0 0
Mexico City
Country [7] 0 0
Mexico
State/province [7] 0 0
Toluca
Country [8] 0 0
Spain
State/province [8] 0 0
Pozuelo De Alarcon
Country [9] 0 0
Spain
State/province [9] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Chemotherapy for patients with non-squamous non-small cell lung cancer. Patients are given
folic acid, vitamin B12 and steroids, both before and during treatment, to reduce the side
effects associated with pemetrexed. The aim is whether it is possible to simplify the folic
acid and steroid schedule without increasing toxicity.
Trial website
https://clinicaltrials.gov/show/NCT00609518
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications