Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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)
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
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)
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)
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
Sex
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
1/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2008
Sample size
Target
Accrual to date
Final
908
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Maine
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Nebraska
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New Mexico
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
United States of America
State/province [25] 0 0
Washington
Country [26] 0 0
United States of America
State/province [26] 0 0
Wisconsin
Country [27] 0 0
Argentina
State/province [27] 0 0
Bahia Blanca
Country [28] 0 0
Argentina
State/province [28] 0 0
Buenos Aires
Country [29] 0 0
Argentina
State/province [29] 0 0
Mar Del Plata
Country [30] 0 0
Argentina
State/province [30] 0 0
Rosario
Country [31] 0 0
Argentina
State/province [31] 0 0
Tucumain
Country [32] 0 0
Austria
State/province [32] 0 0
Graz
Country [33] 0 0
Austria
State/province [33] 0 0
Linz
Country [34] 0 0
Austria
State/province [34] 0 0
Wien
Country [35] 0 0
Belgium
State/province [35] 0 0
Brussels
Country [36] 0 0
Belgium
State/province [36] 0 0
Edegem
Country [37] 0 0
Belgium
State/province [37] 0 0
Leuven
Country [38] 0 0
Belgium
State/province [38] 0 0
Liege
Country [39] 0 0
Belgium
State/province [39] 0 0
Liège
Country [40] 0 0
Brazil
State/province [40] 0 0
Florianópolis
Country [41] 0 0
Brazil
State/province [41] 0 0
Fortaleza
Country [42] 0 0
Brazil
State/province [42] 0 0
Jau
Country [43] 0 0
Brazil
State/province [43] 0 0
Sao Paulo
Country [44] 0 0
China
State/province [44] 0 0
Beijing
Country [45] 0 0
China
State/province [45] 0 0
Guang Zhou
Country [46] 0 0
China
State/province [46] 0 0
Shanghai
Country [47] 0 0
France
State/province [47] 0 0
Brest
Country [48] 0 0
France
State/province [48] 0 0
Caen
Country [49] 0 0
France
State/province [49] 0 0
Clichy
Country [50] 0 0
France
State/province [50] 0 0
Grenoble
Country [51] 0 0
France
State/province [51] 0 0
Lille
Country [52] 0 0
France
State/province [52] 0 0
Lyon
Country [53] 0 0
France
State/province [53] 0 0
Marseille
Country [54] 0 0
France
State/province [54] 0 0
Montpellier
Country [55] 0 0
Germany
State/province [55] 0 0
Borstel
Country [56] 0 0
Germany
State/province [56] 0 0
Freiburg
Country [57] 0 0
Germany
State/province [57] 0 0
Gauting
Country [58] 0 0
Germany
State/province [58] 0 0
Großhansdorf
Country [59] 0 0
Germany
State/province [59] 0 0
Hamburg
Country [60] 0 0
Germany
State/province [60] 0 0
Heidelberg
Country [61] 0 0
Germany
State/province [61] 0 0
Hemer
Country [62] 0 0
Germany
State/province [62] 0 0
Kassel
Country [63] 0 0
Germany
State/province [63] 0 0
Köln
Country [64] 0 0
Germany
State/province [64] 0 0
Nürnberg
Country [65] 0 0
Germany
State/province [65] 0 0
Regensburg
Country [66] 0 0
Germany
State/province [66] 0 0
Rostock
Country [67] 0 0
Germany
State/province [67] 0 0
Stralsund
Country [68] 0 0
Greece
State/province [68] 0 0
Athens
Country [69] 0 0
Greece
State/province [69] 0 0
Heraklion
Country [70] 0 0
Greece
State/province [70] 0 0
Marousi Attikis
Country [71] 0 0
Greece
State/province [71] 0 0
Pylaia/Thessaloniki
Country [72] 0 0
Hungary
State/province [72] 0 0
Deszk
Country [73] 0 0
Hungary
State/province [73] 0 0
Pecs
Country [74] 0 0
Hungary
State/province [74] 0 0
Szekesfehervar
Country [75] 0 0
Hungary
State/province [75] 0 0
Szombathely
Country [76] 0 0
Hungary
State/province [76] 0 0
Torokbalint
Country [77] 0 0
Hungary
State/province [77] 0 0
Zalaegerszeg
Country [78] 0 0
India
State/province [78] 0 0
Ahmedabad
Country [79] 0 0
India
State/province [79] 0 0
Bangalore
Country [80] 0 0
India
State/province [80] 0 0
Kolkata
Country [81] 0 0
India
State/province [81] 0 0
Ludhiana
Country [82] 0 0
India
State/province [82] 0 0
Mumbai
Country [83] 0 0
India
State/province [83] 0 0
New Delhi
Country [84] 0 0
India
State/province [84] 0 0
Pune
Country [85] 0 0
India
State/province [85] 0 0
Trivandrum
Country [86] 0 0
Italy
State/province [86] 0 0
Bergamo
Country [87] 0 0
Italy
State/province [87] 0 0
Livorno
Country [88] 0 0
Italy
State/province [88] 0 0
Monteforte Irpino
Country [89] 0 0
Italy
State/province [89] 0 0
Orbassano
Country [90] 0 0
Italy
State/province [90] 0 0
Parma
Country [91] 0 0
Italy
State/province [91] 0 0
Ravenna
Country [92] 0 0
Italy
State/province [92] 0 0
Rome
Country [93] 0 0
Italy
State/province [93] 0 0
San Sisto
Country [94] 0 0
Korea, Republic of
State/province [94] 0 0
Seoul
Country [95] 0 0
Netherlands
State/province [95] 0 0
Amsterdam
Country [96] 0 0
Netherlands
State/province [96] 0 0
Arnhem
Country [97] 0 0
Netherlands
State/province [97] 0 0
Den Bosch
Country [98] 0 0
Netherlands
State/province [98] 0 0
Groningen
Country [99] 0 0
Netherlands
State/province [99] 0 0
Harderwijk
Country [100] 0 0
Netherlands
State/province [100] 0 0
Heerlen
Country [101] 0 0
New Zealand
State/province [101] 0 0
Auckland
Country [102] 0 0
New Zealand
State/province [102] 0 0
Christchurch
Country [103] 0 0
New Zealand
State/province [103] 0 0
Wellington
Country [104] 0 0
Poland
State/province [104] 0 0
Gdansk
Country [105] 0 0
Poland
State/province [105] 0 0
Krakow-Nowa Huta
Country [106] 0 0
Poland
State/province [106] 0 0
Otwock
Country [107] 0 0
Poland
State/province [107] 0 0
Szczecin-Zdunowo
Country [108] 0 0
Poland
State/province [108] 0 0
Zabrze-Biskupice
Country [109] 0 0
Portugal
State/province [109] 0 0
Coimbra
Country [110] 0 0
Portugal
State/province [110] 0 0
Lisbon
Country [111] 0 0
Portugal
State/province [111] 0 0
Porto
Country [112] 0 0
Portugal
State/province [112] 0 0
Santa Maria Da Feira
Country [113] 0 0
Portugal
State/province [113] 0 0
Vila Nova De Gaia
Country [114] 0 0
Puerto Rico
State/province [114] 0 0
San Juan
Country [115] 0 0
Romania
State/province [115] 0 0
Bucharest
Country [116] 0 0
Romania
State/province [116] 0 0
Cluj-Napoca
Country [117] 0 0
Russian Federation
State/province [117] 0 0
Chelyabinsk
Country [118] 0 0
Russian Federation
State/province [118] 0 0
Engels
Country [119] 0 0
Russian Federation
State/province [119] 0 0
Kazan
Country [120] 0 0
Russian Federation
State/province [120] 0 0
Murmansk
Country [121] 0 0
Russian Federation
State/province [121] 0 0
Saint Petersburg
Country [122] 0 0
Russian Federation
State/province [122] 0 0
Stavropol
Country [123] 0 0
South Africa
State/province [123] 0 0
Cape Town
Country [124] 0 0
South Africa
State/province [124] 0 0
Durban
Country [125] 0 0
South Africa
State/province [125] 0 0
Parktown
Country [126] 0 0
Spain
State/province [126] 0 0
Alicante
Country [127] 0 0
Spain
State/province [127] 0 0
Badalona
Country [128] 0 0
Spain
State/province [128] 0 0
Barakaldo
Country [129] 0 0
Spain
State/province [129] 0 0
Barcelona
Country [130] 0 0
Spain
State/province [130] 0 0
Madrid
Country [131] 0 0
Spain
State/province [131] 0 0
Zaragoza
Country [132] 0 0
Taiwan
State/province [132] 0 0
Niao Sung Hsiang
Country [133] 0 0
Taiwan
State/province [133] 0 0
Taichung
Country [134] 0 0
Taiwan
State/province [134] 0 0
Taipei
Country [135] 0 0
Turkey
State/province [135] 0 0
Besevler/Ankara
Country [136] 0 0
Turkey
State/province [136] 0 0
Gaziantep
Country [137] 0 0
Turkey
State/province [137] 0 0
Istanbul
Country [138] 0 0
Turkey
State/province [138] 0 0
Izmir
Country [139] 0 0
Turkey
State/province [139] 0 0
Samsun
Country [140] 0 0
United Kingdom
State/province [140] 0 0
Avon
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Cornwall
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Essex
Country [143] 0 0
United Kingdom
State/province [143] 0 0
Scotland
Country [144] 0 0
United Kingdom
State/province [144] 0 0
West Midlands
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Manchester

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00363415