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

NCT ID: NCT00404703

Last Updated: 2016-08-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2008-02-29

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.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type: DRUG

15mg iv on day 1 of each 3 week cycle

Platinum-based chemotherapy

Intervention Type: DRUG

As prescribed

Interventions

bevacizumab [Avastin]

15mg iv on day 1 of each 3 week cycle

Intervention Type: DRUG

Platinum-based chemotherapy

As prescribed

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Tugun, , Australia

Wollongong, , Australia

Liège, , Belgium

Ostrava, , Czechia

Ústí nad Labem, , Czechia

Bobigny, , France

Marseille, , France

Nantes, , France

Székesfehérvár, , Hungary

Szombathely, , Hungary

Kfar Saba, , Israel

Ramat Gan, , Israel

Lublin, , Poland

Poznan, , Poland

Szczecin, , Poland

Warsaw, , Poland

Balashikha, , Russia

Moscow, , Russia

Saint Petersburg, , Russia

Madrid, , Spain

Seville, , Spain

Kueishan, , Taiwan

Taichung, , Taiwan

Taipei, , Taiwan

Taoyuan District, , Taiwan

Countries

Australia; Belgium; Czechia; France; Hungary; Israel; Poland; Russia; Spain; Taiwan

Other Identifiers

BO19734

Identifier Type: -

Identifier Source: org_study_id