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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00404703




Registration number
NCT00404703
Ethics application status
Date submitted
28/11/2006
Date registered
29/11/2006
Date last updated
24/08/2016

Titles & IDs
Public title
A Study of Avastin (Bevacizumab) in Combination With Platinum-Based Chemotherapy in Patients With Advanced or Recurrent Squamous Non-Small Cell Lung Cancer
Scientific title
An Open Label Study of the Safety of First-line Treatment With Avastin in Combination With Cisplatin-gemcitabine or Carboplatin-paclitaxel in Patients With Advanced or Recurrent Squamous Non-small Cell Lung Cancer, Who Are Considered to be at High Risk of Pulmonary Haemorrhage
Secondary ID [1] 0 0
BO19734
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 - Platinum-based chemotherapy

Experimental: 1 -


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

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

Outcomes
Primary outcome [1] 0 0
Rate of grade >=3 Avastin-related pulmonary hemorrhage
Timepoint [1] 0 0
After a maximum of 12 months treatment
Secondary outcome [1] 0 0
Overall response, duration of response, progression-free survival.
Timepoint [1] 0 0
Event driven
Secondary outcome [2] 0 0
AEs, laboratory parameters, coagulation parameters.
Timepoint [2] 0 0
Throughout study

Eligibility
Key inclusion criteria
* adult patients, >=18 years of age;
* documented squamous non-small cell lung cancer;
* stage IIIb with pleural or pericardial effusion, stage IV, or recurrent disease;
* suitable for platinum-based treatment as first line chemotherapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* prior systemic anti-tumor therapy;
* prior radiotherapy for treatment of patient's current stage of disease;
* other primary tumors within last 5 years, except for controlled limited basal cell or squamous cancer of the skin, or cancer in situ of the cervix;
* major surgery, open biopsy or significant traumatic injury within 28 days prior to randomization.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Phase 2
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
1/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2008
Sample size
Target
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Tugun
Recruitment hospital [2] 0 0
- Wollongong
Recruitment postcode(s) [1] 0 0
- Tugun
Recruitment postcode(s) [2] 0 0
- Wollongong
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Liege
Country [2] 0 0
Czech Republic
State/province [2] 0 0
Ostrava
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Usti nad Labem
Country [4] 0 0
France
State/province [4] 0 0
Bobigny
Country [5] 0 0
France
State/province [5] 0 0
Marseille
Country [6] 0 0
France
State/province [6] 0 0
Nantes
Country [7] 0 0
Hungary
State/province [7] 0 0
Szekesfehervar
Country [8] 0 0
Hungary
State/province [8] 0 0
Szombathely
Country [9] 0 0
Israel
State/province [9] 0 0
Kfar Saba
Country [10] 0 0
Israel
State/province [10] 0 0
Ramat Gan
Country [11] 0 0
Poland
State/province [11] 0 0
Lublin
Country [12] 0 0
Poland
State/province [12] 0 0
Poznan
Country [13] 0 0
Poland
State/province [13] 0 0
Szczecin
Country [14] 0 0
Poland
State/province [14] 0 0
Warszawa
Country [15] 0 0
Russian Federation
State/province [15] 0 0
Balashikha
Country [16] 0 0
Russian Federation
State/province [16] 0 0
Moscow
Country [17] 0 0
Russian Federation
State/province [17] 0 0
St. Petersburg
Country [18] 0 0
Spain
State/province [18] 0 0
Madrid
Country [19] 0 0
Spain
State/province [19] 0 0
Sevilla
Country [20] 0 0
Taiwan
State/province [20] 0 0
Kueishan
Country [21] 0 0
Taiwan
State/province [21] 0 0
Taichung
Country [22] 0 0
Taiwan
State/province [22] 0 0
Taipei
Country [23] 0 0
Taiwan
State/province [23] 0 0
Taoyuan

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

Ethics approval
Ethics application status

Summary
Brief summary
This single arm study will assess the feasibility of using Avastin plus platinum-based chemotherapy (cisplatin-gemcitabine or carboplatin-paclitaxel) in patients with advanced or recurrent squamous non-small cell lung cancer who have not received prior chemotherapy. Patients will receive preventive radiation, followed by one cycle of chemotherapy alone and 5 cycles of chemotherapy in combination with Avastin (15mg/kg iv on day 1 of each 3 weekly cycle), followed by Avastin alone for a maximum total treatment period with Avastin of 12 months. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
Trial website
https://clinicaltrials.gov/study/NCT00404703
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00404703