A Study of Avastin (Bevacizumab) in Combination With Platinum-Based Chemotherapy in Patients With Advanced or Recurrent Squamous Non-Small Cell Lung Cancer

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00404703
• Other study ID #: BO19734
• Status: Terminated
• Phase: Phase 2
• First received: November 28, 2006
• Last updated: August 23, 2016
• Start date: August 2006
• Est. completion date: February 2008

Study information

• Verified date: August 2008
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• bevacizumab [Avastin]
15mg iv on day 1 of each 3 week cycle
• Platinum-based chemotherapy
As prescribed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Australia,  Belgium,  Czech Republic,  France,  Hungary,  Israel,  Poland,  Russian Federation,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of grade >=3 Avastin-related pulmonary hemorrhage		After a maximum of 12 months treatment	Yes
Secondary	Overall response, duration of response, progression-free survival.		Event driven	No
Secondary	AEs, laboratory parameters, coagulation parameters.		Throughout study	No