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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - Overall response was analyzed and correlated within dichotomized (low- and high-level) baseline plasma biomarker (basic fibroblast growth factor [bFGF], E-selection, intracellular adhesion molecule [ICAM], placental growth factor [PlGF], vascular endothelial growth factor A [VEGF A], vascular endothelial growth factor receptor [VEGFR]-1, and VEGFR-2) subgroups: low-level equals (=) less than or equal to (=) median baseline level, high-level=greater than (>) median baseline level. Per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.0 CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR defined as greater than or equal to (=)30 percent (%) decrease under baseline of the sum of the longest diameter (LD) of all target lesions. No unequivocal progression of non-target disease; no new lesions. Complete and partial responses must have been confirmed no less than 4 weeks after criteria for response were first met
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 - PFS was defined as the time between randomization and progressive disease (PD) according to RECIST criteria, or death due to any cause. PD was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. Disease progression was evaluated according to the RECIST using computed tomography (CT) scans, magnetic resonance imaging (MRI) scans, X-ray, bone scans, or clinical examination. Participants without an event were censored at the date of last follow up for progression. Participants with no post baseline follow-up for progression were censored at the day of randomization.
Timepoint [1] 0 0
Baseline, Day 1, weekly to disease progression
Secondary outcome [2] 0 0
Progression-Free Survival - Time to Event - PFS was defined as the time between randomization and disease progression or death due to any cause. Participants without an event were censored at the date of last follow up for progression. Participants with no post baseline follow-up for progression were censored at the day of randomization. Disease progression was evaluated according to the RECIST using CT scans, MRI scans, X-ray, bone scans, or clinical examination. Median PFS was estimated using the Kaplan-Meier method.
Timepoint [2] 0 0
Baseline, Day 1, weekly to disease progression
Secondary outcome [3] 0 0
Percentage of Participants With Objective Response - Percentage of participants with CR or PR according to RECIST criteria. Per RECIST v1.0: CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as =30% decrease under baseline of the sum of the LD of all target lesions. No unequivocal progression of non-target disease. No new lesions. Complete and partial responses were confirmed no less than 4 weeks after the criteria for response were first met.
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 - Percentage of participants with measurable disease at baseline who on assessment achieved CR, PR, or SD according to RECIST. Per RECIST v1.0: CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as =30% decrease under baseline of the sum of the LD of all target lesions. No unequivocal progression of non-target disease. No new lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since start of treatment. Complete and partial responses must have been confirmed no less than 4 weeks after the criteria for response were first met. For participants with SD, follow-up assessments must have met the SD criteria at least once after study entry at a minimum interval of 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 - Duration of response is defined as time in months from the first documentation of objective tumor response (CR or PR) to objective tumor progression or death due to any cause. Participants without an event (documented progression or death) were censored at the date of last follow-up for progression. Duration of response was only calculated for participants who had a confirmed objective tumor response (CR or PR).
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 - The median time, in months, from the first documentation of objective tumor response (CR or PR) to objective tumor progression or death due to any cause. Participants without an event (documented progression or death) were censored at the date of last follow-up for progression. Duration of response was only calculated for participants who had a confirmed objective tumor response (CR or PR). Median Duration of Response was estimated using the Kaplan-Meier method.
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 - Overall survival was defined as the time between randomization and death due to any cause. Participants without an event were censored at the last time they were known to be alive. Overall Survival was estimated using the Kaplan-Meier method.
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 - Overall survival was defined as the time between randomization and death due to any cause. Participants without an event were censored at the last time they were known to be alive. Overall Survival was estimated using the Kaplan-Meier method.
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
Gender
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
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,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
This study will explore the correlation of biomarkers with response rate, and the overall
efficacy and safety, of Avastin in combination with carboplatin-based chemotherapy in
patients with advanced or recurrent non-squamous non-small cell lung cancer. Patients will be
randomized to one of 2 groups, to receive either Avastin 7.5mg/kg iv on day 1 of each 3 week
cycle, or Avastin 15mg/kg iv on day 1 of each 3 week cycle; all patients will also receive
treatment with carboplatin and either gemcitabine or paclitaxel for a maximum of 6 cycles.
The anticipated time on study treatment is until disease progression, and the target sample
size is 100-500 individuals.
Trial website
https://clinicaltrials.gov/show/NCT00700180
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

Summary results
Other publications