Clinical trial NCT00404703: A Study of Avastin (Bevacizumab) in Combination With Platinum-Based Chemotherapy in Patients With Advanced or Recurrent Squamous Non-Small Cell Lung Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-11-29
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Rate of grade >=3 Avastin-related pulmonary hemorrhage
timeFrame: After a maximum of 12 months treatment
Secondary outcomes:
measure: Overall response, duration of response, progression-free survival.
timeFrame: Event driven
measure: AEs, laboratory parameters, coagulation parameters.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Tugun
country: Australia
city: Wollongong
country: Australia
city: Liege
country: Belgium
city: Ostrava
country: Czech Republic
city: Usti nad Labem
country: Czech Republic
city: Bobigny
country: France
city: Marseille
country: France
city: Nantes
country: France
city: Szekesfehervar
country: Hungary
city: Szombathely
country: Hungary
city: Kfar Saba
country: Israel
city: Ramat Gan
country: Israel
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Szczecin
country: Poland
city: Warszawa
country: Poland
city: Balashikha
country: Russian Federation
city: Moscow
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Madrid
country: Spain
city: Sevilla
country: Spain
city: Kueishan
country: Taiwan
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: