Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/NCT00596830




Registration number
NCT00596830
Ethics application status
Date submitted
3/01/2008
Date registered
17/01/2008
Date last updated
13/01/2014

Titles & IDs
Public title
Carboplatin And Paclitaxel With Or Without CP-751, 871 (An IGF-1R Inhibitor) For Advanced NSCLC Of Squamous, Large Cell And Adenosquamous Carcinoma Histology
Scientific title
Randomized, Open Label, Phase III Trial Of CP- 751,871 In Combination With Paclitaxel And Carboplatin Versus Paclitaxel And Carboplatin In Patients With Non Small Cell Lung Cancer
Secondary ID [1] 0 0
A4021016
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Squamous Cell 0 0
Carcinoma, Adenosquamous 0 0
Carcinoma, Large Cell 0 0
Carcinoma, Non-Small-Cell Lung 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CP-751,871 (Figitumumab)
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel

Experimental: A - Patients in Arm A will receive CP-751, 871 in combination with paclitaxel and carboplatin intravenously every 21 days for up to six cycles.'

Active comparator: B - Patient in Arm B will receive paclitaxel and carboplatin intravenously every 21 days for up to six cycles.


Treatment: Drugs: CP-751,871 (Figitumumab)
CP 751,871 is a potent and selective fully human monoclonal antibody against the insulin like growth factor 1 receptor (IGF-1R). Patients in Arm A will receive CP-751, 871 intravenously every 21 days for up to six cycles.

Treatment: Drugs: Carboplatin
Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive carboplatin intravenously every 21 days for up to six cycles.

Treatment: Drugs: Paclitaxel
Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive paclitaxel intravenously every 21 days for up to six cycles.

Treatment: Drugs: Carboplatin
Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive carboplatin intravenously every 21 days for up to six cycles.

Treatment: Drugs: Paclitaxel
Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive paclitaxel intravenously every 21 days for up to six cycles.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Baseline until death, assessed monthly after end of treatment, up to 30 months
Secondary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
At baseline, every 6 weeks until radiological disease progression or the participant begins a subsequent anticancer therapy, up to 22.7 months.
Secondary outcome [2] 0 0
Percentage of Participants With Objective Response (OR)
Timepoint [2] 0 0
At baseline, every 6 weeks until radiological disease progression has been documented or the participant begins a subsequent anticancer therapy, up to 22.7 months
Secondary outcome [3] 0 0
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
Timepoint [3] 0 0
Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months
Secondary outcome [4] 0 0
European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) Score
Timepoint [4] 0 0
Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months
Secondary outcome [5] 0 0
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
Timepoint [5] 0 0
Day 1 of every cycle (3-weeks cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months
Secondary outcome [6] 0 0
Maximum Observed Plasma Concentration (Cmax) for Figitumumab
Timepoint [6] 0 0
Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose
Secondary outcome [7] 0 0
Minimum Observed Plasma Trough Concentration (Cmin)for Figitumumab
Timepoint [7] 0 0
Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose
Secondary outcome [8] 0 0
Number of Participants With Total Anti-drug Antibodies (ADA)
Timepoint [8] 0 0
Cycles 1, 2, and 4 (predose); 28 days and 150 days after the last figi dose
Secondary outcome [9] 0 0
Change From Baseline in Serum Insulin Growth Factor 1 (IGF1) Levels
Timepoint [9] 0 0
Cycles 1 and 4 (predose) and at end of treatment

Eligibility
Key inclusion criteria
* Confirmed diagnosis of non small cell lung cancer with a primary histology of predominantly squamous cell, large cell or adenosquamous carcinoma.
* Advanced NSCLC with documented Stage IIIB (with pleural effusion) or Stage IV or recurrent disease.
* No prior systemic treatment for NSCLC, except for adjuvant chemotherapy. Adjuvant chemotherapy must have completed for greater than or equal to 12 months prior to randomization.
* Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to randomization and all acute toxicities have resolved.
* ECOG performance status (PS) 0 or 1.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with symptomatic central nervous system (CNS) metastases are not permitted.
* Patients requiring chronic steroid use or patients with uncontrolled diabetes are not permitted.
* Patients with other active cancer types are not permitted.

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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2012
Sample size
Target
Accrual to date
Final
681
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Albury
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Port Macquarie
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Geelong
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Wodonga
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [3] 0 0
3220 - Geelong
Recruitment postcode(s) [4] 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
Arizona
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
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Mississippi
Country [19] 0 0
United States of America
State/province [19] 0 0
Missouri
Country [20] 0 0
United States of America
State/province [20] 0 0
Nebraska
Country [21] 0 0
United States of America
State/province [21] 0 0
Nevada
Country [22] 0 0
United States of America
State/province [22] 0 0
New Hampshire
Country [23] 0 0
United States of America
State/province [23] 0 0
New York
Country [24] 0 0
United States of America
State/province [24] 0 0
North Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Ohio
Country [26] 0 0
United States of America
State/province [26] 0 0
Oklahoma
Country [27] 0 0
United States of America
State/province [27] 0 0
Pennsylvania
Country [28] 0 0
United States of America
State/province [28] 0 0
South Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
Tennessee
Country [30] 0 0
United States of America
State/province [30] 0 0
Texas
Country [31] 0 0
United States of America
State/province [31] 0 0
Utah
Country [32] 0 0
United States of America
State/province [32] 0 0
Virginia
Country [33] 0 0
United States of America
State/province [33] 0 0
Washington
Country [34] 0 0
Austria
State/province [34] 0 0
Linz
Country [35] 0 0
Austria
State/province [35] 0 0
Wien
Country [36] 0 0
Brazil
State/province [36] 0 0
RJ
Country [37] 0 0
Brazil
State/province [37] 0 0
Sao Paulo/ Brazil
Country [38] 0 0
Brazil
State/province [38] 0 0
SP
Country [39] 0 0
Bulgaria
State/province [39] 0 0
Sofia
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Varna
Country [41] 0 0
Canada
State/province [41] 0 0
Alberta
Country [42] 0 0
Canada
State/province [42] 0 0
Quebec
Country [43] 0 0
Czech Republic
State/province [43] 0 0
Nova Ves pod Plesi
Country [44] 0 0
Czech Republic
State/province [44] 0 0
Praha 8
Country [45] 0 0
Czech Republic
State/province [45] 0 0
Pribram I
Country [46] 0 0
Czech Republic
State/province [46] 0 0
Pribram V
Country [47] 0 0
Finland
State/province [47] 0 0
Helsinki
Country [48] 0 0
Finland
State/province [48] 0 0
Pori
Country [49] 0 0
France
State/province [49] 0 0
Caen Cedex 05
Country [50] 0 0
France
State/province [50] 0 0
Caen Cedex
Country [51] 0 0
France
State/province [51] 0 0
Clermond-Ferrand Cedex 01
Country [52] 0 0
France
State/province [52] 0 0
Dijon
Country [53] 0 0
France
State/province [53] 0 0
Lyon Cedex 04
Country [54] 0 0
France
State/province [54] 0 0
Nantes Cedex 2
Country [55] 0 0
France
State/province [55] 0 0
Rennes Cedex 9
Country [56] 0 0
France
State/province [56] 0 0
Saint Herblain Cedex
Country [57] 0 0
France
State/province [57] 0 0
Saint Pierre la Réunion Cedex
Country [58] 0 0
Germany
State/province [58] 0 0
Grosshansdorf
Country [59] 0 0
Germany
State/province [59] 0 0
Karlsruhe
Country [60] 0 0
Germany
State/province [60] 0 0
Leipzig
Country [61] 0 0
Germany
State/province [61] 0 0
Mainz
Country [62] 0 0
Germany
State/province [62] 0 0
Oldenburg
Country [63] 0 0
Greece
State/province [63] 0 0
Pylaia
Country [64] 0 0
Greece
State/province [64] 0 0
Athens
Country [65] 0 0
Greece
State/province [65] 0 0
Thessaloniki
Country [66] 0 0
Hong Kong
State/province [66] 0 0
Kowloon
Country [67] 0 0
Hong Kong
State/province [67] 0 0
Shatin, New Territories
Country [68] 0 0
Hong Kong
State/province [68] 0 0
Tuen Mun
Country [69] 0 0
Hungary
State/province [69] 0 0
Budapest
Country [70] 0 0
Hungary
State/province [70] 0 0
Deszk
Country [71] 0 0
Hungary
State/province [71] 0 0
Szekesfehervar
Country [72] 0 0
Hungary
State/province [72] 0 0
Szombathely
Country [73] 0 0
Hungary
State/province [73] 0 0
Torokbalint
Country [74] 0 0
India
State/province [74] 0 0
Gujarat
Country [75] 0 0
India
State/province [75] 0 0
Karnataka
Country [76] 0 0
India
State/province [76] 0 0
Maharashtra
Country [77] 0 0
India
State/province [77] 0 0
New Delhi
Country [78] 0 0
Italy
State/province [78] 0 0
Genova
Country [79] 0 0
Italy
State/province [79] 0 0
Orbassano (TO)
Country [80] 0 0
Italy
State/province [80] 0 0
Padova
Country [81] 0 0
Italy
State/province [81] 0 0
Roma
Country [82] 0 0
Japan
State/province [82] 0 0
Chiba
Country [83] 0 0
Japan
State/province [83] 0 0
Ehime
Country [84] 0 0
Japan
State/province [84] 0 0
Gifu
Country [85] 0 0
Japan
State/province [85] 0 0
Hokkaido
Country [86] 0 0
Japan
State/province [86] 0 0
Hyogo
Country [87] 0 0
Japan
State/province [87] 0 0
Kanagawa
Country [88] 0 0
Japan
State/province [88] 0 0
Osaka-fu
Country [89] 0 0
Japan
State/province [89] 0 0
Osaka
Country [90] 0 0
Japan
State/province [90] 0 0
Tokyo
Country [91] 0 0
Korea, Republic of
State/province [91] 0 0
Gyeonggi-do
Country [92] 0 0
Korea, Republic of
State/province [92] 0 0
Seoul
Country [93] 0 0
Poland
State/province [93] 0 0
Gdansk
Country [94] 0 0
Poland
State/province [94] 0 0
Krakow
Country [95] 0 0
Poland
State/province [95] 0 0
Siedlce
Country [96] 0 0
Poland
State/province [96] 0 0
Warszawa
Country [97] 0 0
Poland
State/province [97] 0 0
Wroclaw
Country [98] 0 0
Puerto Rico
State/province [98] 0 0
Ponce
Country [99] 0 0
Russian Federation
State/province [99] 0 0
Moscow
Country [100] 0 0
Russian Federation
State/province [100] 0 0
Saint-Petersburg
Country [101] 0 0
Russian Federation
State/province [101] 0 0
Samara
Country [102] 0 0
Russian Federation
State/province [102] 0 0
Sochi
Country [103] 0 0
Russian Federation
State/province [103] 0 0
St-Petersburg
Country [104] 0 0
Russian Federation
State/province [104] 0 0
St. Petersburg
Country [105] 0 0
Slovakia
State/province [105] 0 0
Nitra-Zobor
Country [106] 0 0
Slovakia
State/province [106] 0 0
Nove Zamky
Country [107] 0 0
Slovakia
State/province [107] 0 0
Poprad
Country [108] 0 0
Spain
State/province [108] 0 0
Barcelona
Country [109] 0 0
Spain
State/province [109] 0 0
Cantabria
Country [110] 0 0
Spain
State/province [110] 0 0
Navarra
Country [111] 0 0
Spain
State/province [111] 0 0
Cordoba
Country [112] 0 0
Spain
State/province [112] 0 0
Madrid
Country [113] 0 0
Spain
State/province [113] 0 0
Valencia
Country [114] 0 0
Switzerland
State/province [114] 0 0
Fribourg
Country [115] 0 0
Switzerland
State/province [115] 0 0
Zuerich
Country [116] 0 0
Taiwan
State/province [116] 0 0
Kaohsiung Hsien
Country [117] 0 0
Taiwan
State/province [117] 0 0
Tainan
Country [118] 0 0
Taiwan
State/province [118] 0 0
Taipei
Country [119] 0 0
Turkey
State/province [119] 0 0
Adana
Country [120] 0 0
Turkey
State/province [120] 0 0
Ankara
Country [121] 0 0
Ukraine
State/province [121] 0 0
Dnipropetrovsk
Country [122] 0 0
Ukraine
State/province [122] 0 0
Donetsk
Country [123] 0 0
Ukraine
State/province [123] 0 0
Kyiv
Country [124] 0 0
Ukraine
State/province [124] 0 0
Lviv
Country [125] 0 0
Ukraine
State/province [125] 0 0
Sumy

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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/NCT00596830