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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00700180




Registration number
NCT00700180
Ethics application status
Date submitted
17/06/2008
Date registered
18/06/2008
Date last updated
25/09/2014

Titles & IDs
Public title
A Study of Avastin (Bevacizumab) in Combination With Carboplatin-Based Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer.
Scientific title
A Randomized, Open-label Study to Explore the Correlation of Biomarkers With Response Rate in Chemo-naive Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer Who Receive Treatment With Avastin in Addition to Carboplatin-based Chemotherapy
Secondary ID [1] 0 0
2008-000662-23
Secondary ID [2] 0 0
BO21015
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 - bevacizumab [Avastin]
Treatment: Drugs - bevacizumab [Avastin]
Treatment: Drugs - Carboplatin-based chemotherapy

Experimental: 1 -

Experimental: 2 -


Treatment: Drugs: bevacizumab [Avastin]
7.5mg/kg iv on day 1 of each 3 week cycle

Treatment: Drugs: bevacizumab [Avastin]
15mg/kg iv on day 1 of each 3 week cycle

Treatment: Drugs: Carboplatin-based chemotherapy
As prescribed
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Dichotomized Baseline Plasma Marker Level
Timepoint [1] 0 0
Baseline, Day 21 of Cycles 2, 4, and 6 (Bv + chemo), Day 21 of Cycles 7, 8, 9, and 10 (Bv), Day 21 of every other cycle (Bv), and at disease progression.
Secondary outcome [1] 0 0
Progression-Free Survival - Percentage of Participants With an Event
Timepoint [1] 0 0
Baseline, Day 1, weekly to disease progression
Secondary outcome [2] 0 0
Progression-Free Survival - Time to Event
Timepoint [2] 0 0
Baseline, Day 1, weekly to disease progression
Secondary outcome [3] 0 0
Percentage of Participants With Objective Response
Timepoint [3] 0 0
Baseline, Day 21 of Cycles 2, 4, and 6, Day 21 of Cycles 7, 8, 9, and 10, Day 21 of every other cycle, and at disease progression
Secondary outcome [4] 0 0
Percentage of Participants With Measurable Disease at Baseline Who Achieved CR, PR, or Stable Disease (SD) for at Least 6 Weeks
Timepoint [4] 0 0
Baseline, Day 21 of Cycles 2, 4, and 6, Day 21 of Cycles 7, 8, 9, and 10, Day 21 of every other cycle, and at disease progression
Secondary outcome [5] 0 0
Duration of Response - Percentage of Participants With an Event
Timepoint [5] 0 0
Baseline, Day 21 of Cycles 2, 4, and 6, Day 21 of Cycles 7, 8, 9, and 10, Day 21 of every other cycle, and at disease progression
Secondary outcome [6] 0 0
Duration of Response - Time to Event
Timepoint [6] 0 0
Baseline, Day 21 of Cycles 2, 4, and 6 (Bv + chemo), Day 21 of Cycles 7, 8, 9, and 10 (Bv), Day 21 of every other cycle (Bv), and at disease progression.
Secondary outcome [7] 0 0
Overall Survival - Percentage of Participants With an Event
Timepoint [7] 0 0
Baseline, weekly to 28 days after last dose of study treatment, every 8 weeks thereafter to death due to any cause
Secondary outcome [8] 0 0
Overall Survival - Time to Event
Timepoint [8] 0 0
Baseline, weekly to death due to any cause, or to end of study

Eligibility
Key inclusion criteria
* adult patients, >=18 years of age;
* locally advanced metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC);
* >=1 measurable tumor lesion;
* ECOG performance status 0-1.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* prior chemotherapy or treatment with another systemic anti-cancer agent;
* evidence of CNS metastases;
* history of grade 2 or higher hemoptysis;
* evidence of tumor invading or abutting major blood vessels;
* malignancies other than NSCLC within 5 years prior to randomization, other than adequately treated cancer in situ of cervix, basal or squamous cell skin cancer, localized prostate cancer or DCIS;
* clinically significant cardiovascular disease;
* current or recent use of aspirin (>325mg/day) or full dose anticoagulants or thrombolytic agents for therapeutic purposes.

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
1/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2012
Sample size
Target
Accrual to date
Final
303
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
- St. Leonards
Recruitment hospital [2] 0 0
- Adelaide
Recruitment hospital [3] 0 0
- Box Hill
Recruitment hospital [4] 0 0
- Fitzroy
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
5041 - Adelaide
Recruitment postcode(s) [3] 0 0
5065 - Adelaide
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerpen
Country [2] 0 0
Belgium
State/province [2] 0 0
Liege
Country [3] 0 0
Canada
State/province [3] 0 0
British Columbia
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Czech Republic
State/province [5] 0 0
Ostrava
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Praha
Country [7] 0 0
Denmark
State/province [7] 0 0
Odense
Country [8] 0 0
France
State/province [8] 0 0
Paris
Country [9] 0 0
France
State/province [9] 0 0
Rouen
Country [10] 0 0
Germany
State/province [10] 0 0
Bad Berka
Country [11] 0 0
Germany
State/province [11] 0 0
Grosshansdorf
Country [12] 0 0
Germany
State/province [12] 0 0
Hamburg
Country [13] 0 0
Germany
State/province [13] 0 0
Oldenburg
Country [14] 0 0
Hong Kong
State/province [14] 0 0
Hong Kong
Country [15] 0 0
Hungary
State/province [15] 0 0
Budapest
Country [16] 0 0
Hungary
State/province [16] 0 0
Edeleny
Country [17] 0 0
Hungary
State/province [17] 0 0
Sopron
Country [18] 0 0
Hungary
State/province [18] 0 0
Szombathely
Country [19] 0 0
Hungary
State/province [19] 0 0
Torokbalint
Country [20] 0 0
Italy
State/province [20] 0 0
Milano
Country [21] 0 0
Italy
State/province [21] 0 0
Milan
Country [22] 0 0
Italy
State/province [22] 0 0
Orbassano
Country [23] 0 0
Italy
State/province [23] 0 0
Roma
Country [24] 0 0
Netherlands
State/province [24] 0 0
Den Haag
Country [25] 0 0
Netherlands
State/province [25] 0 0
Enschede
Country [26] 0 0
Netherlands
State/province [26] 0 0
Hoorn
Country [27] 0 0
Netherlands
State/province [27] 0 0
Nieuwegein
Country [28] 0 0
Netherlands
State/province [28] 0 0
Rotterdam
Country [29] 0 0
Poland
State/province [29] 0 0
Poznan
Country [30] 0 0
Poland
State/province [30] 0 0
Warszawa
Country [31] 0 0
Poland
State/province [31] 0 0
Zabrze
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Arkhangelsk
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Chelyabinsk
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Kazan
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Krasnodar
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Moscow
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Saint-Petersburg
Country [38] 0 0
Russian Federation
State/province [38] 0 0
St Petersburg
Country [39] 0 0
Spain
State/province [39] 0 0
Vizcaya
Country [40] 0 0
Spain
State/province [40] 0 0
Sevilla
Country [41] 0 0
Spain
State/province [41] 0 0
Valencia
Country [42] 0 0
Taiwan
State/province [42] 0 0
Changhua
Country [43] 0 0
Taiwan
State/province [43] 0 0
Taichung
Country [44] 0 0
Taiwan
State/province [44] 0 0
Taipei
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Aberdeen
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Chelmsford
Country [47] 0 0
United Kingdom
State/province [47] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
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/NCT00700180