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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Gender
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
Terminated
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)
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/show/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/show/NCT00404703