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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00363415




Registration number
NCT00363415
Ethics application status
Date submitted
10/08/2006
Date registered
15/08/2006
Date last updated
28/10/2009

Titles & IDs
Public title
Study of Pemetrexed and Carboplatin Compared With Etoposide Carboplatin to Treat Extensive-Stage Small Cell Lung Cancer
Scientific title
A Randomized Phase 3 Trial of Alimta (Pemetrexed) and Carboplatin Versus Etoposide and Carboplatin in Extensive-Stage Small Cell Lung Cancer
Secondary ID [1] 0 0
H3E-MC-JMHO
Secondary ID [2] 0 0
9691
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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
Treatment: Drugs - etoposide
Treatment: Drugs - carboplatin

Experimental: A -

Active Comparator: B -


Treatment: Drugs: pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 6 cycles

Treatment: Drugs: etoposide
100 mg/m2, intravenous (IV), days 1-3 x 6 cycles

Treatment: Drugs: carboplatin
Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles

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

Outcomes
Primary outcome [1] 0 0
Overall Survival - Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Timepoint [1] 0 0
baseline to date of death from any cause (up to 19.6 months)
Secondary outcome [1] 0 0
Overall Survival (Subgroups) - The effects of individual baseline factors (sex, race, Eastern Cooperative Oncology Group (ECOG) performance, region, lactate dehydrogenase (LDH), age, number of metastatic sites, and history of brain metastases) on overall survival are reported. For two subgroups - LDH<=upper limit of normal and brain metastases=yes, the upper limits of the 95% confidence interval were not calculable for the etoposide+carboplatin group - instead the number of participants in these two subgroups are presented as a post-hoc outcome measure.
Timepoint [1] 0 0
baseline to date of death from any cause (up to 19.6 months)
Secondary outcome [2] 0 0
Progression Free Survival - The period from study entry until disease progression, death or date of last contact.
Timepoint [2] 0 0
baseline to measured progressive disease (up to 14.7 months)
Secondary outcome [3] 0 0
Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy - Lung (FACT-L) - FACT-L measures following domains of health-related quality of life (HR-QL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of lung cancer. Total scores range from 0 to 136, with higher scores representing better HR-QL. A clinically meaningful change is considered to be 5 points.
Timepoint [3] 0 0
baseline and 6 cycles (21-day cycles)
Secondary outcome [4] 0 0
Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes) - The effects of individual baseline factors (lactate dehydrogenase (LDH) and history of brain metastases) on overall survival are reported. The Upper Limits of the 95% Confidence Intervals were not calculable for these factors in the Etoposide+Carboplatin group. The number of participants in these subgroup are instead presented as a Post-Hoc Outcome Measure.
Timepoint [4] 0 0
baseline to date of death due to any cause (up to 19.6 months)

Eligibility
Key inclusion criteria
- Clinical diagnosis of extensive stage small cell lung cancer (SCLC)

- Capable of self-care but may be unable to carry out any work activities.

- No prior anticancer therapy for SCLC
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- have previously participated in a study involving pemetrexed

- have received treatment within the last 30 days with a drug that has not received
regulatory approval for any indication

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 3
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,SA,TAS,VIC
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. - Camperdown
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. - Coffs Harbour
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. - Port Macquarie
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. - Wollongong
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. - Brisbane
Recruitment hospital [6] 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. - Chermisdie
Recruitment hospital [7] 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 hospital [8] 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. - South Brisbane
Recruitment hospital [9] 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. - Townsville
Recruitment hospital [10] 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. - Adelaide
Recruitment hospital [11] 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. - Woodville
Recruitment hospital [12] 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. - Hobart
Recruitment hospital [13] 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. - Frankston
Recruitment hospital [14] 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. - Geelong
Recruitment hospital [15] 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. - Wodonga
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
4029 - Brisbane
Recruitment postcode(s) [6] 0 0
4032 - Chermisdie
Recruitment postcode(s) [7] 0 0
4020 - Redcliffe
Recruitment postcode(s) [8] 0 0
4101 - South Brisbane
Recruitment postcode(s) [9] 0 0
4810 - Townsville
Recruitment postcode(s) [10] 0 0
5000 - Adelaide
Recruitment postcode(s) [11] 0 0
5011 - Woodville
Recruitment postcode(s) [12] 0 0
7001 - Hobart
Recruitment postcode(s) [13] 0 0
3199 - Frankston
Recruitment postcode(s) [14] 0 0
3220 - Geelong
Recruitment postcode(s) [15] 0 0
3690 - Wodonga
Recruitment outside Australia
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Alabama
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Maine
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Michigan
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is a Phase 3, global, multi-center, open-label study of patients with
extensive-stage small cell lung cancer. Eligible patients will be randomly assigned to
receive either pemetrexed plus carboplatin or etoposide plus carboplatin. It is anticipated
that pemetrexed plus carboplatin will offer similar survival benefits as compared to
etoposide plus carboplatin.
Trial website
https://clinicaltrials.gov/show/NCT00363415
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