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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00404703
Recruitment Status : Terminated (Primary (safety) endpoint reached)
First Posted : November 29, 2006
Last Update Posted : August 24, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: bevacizumab [Avastin] Drug: Platinum-based chemotherapy Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Bevacizumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: bevacizumab [Avastin]
15mg iv on day 1 of each 3 week cycle
Drug: Platinum-based chemotherapy
As prescribed

Primary Outcome Measures :
  1. Rate of grade >=3 Avastin-related pulmonary hemorrhage [ Time Frame: After a maximum of 12 months treatment ]

Secondary Outcome Measures :
  1. Overall response, duration of response, progression-free survival. [ Time Frame: Event driven ]
  2. AEs, laboratory parameters, coagulation parameters. [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00404703

Tugun, Australia
Wollongong, Australia
Liege, Belgium
Czech Republic
Ostrava, Czech Republic
Usti nad Labem, Czech Republic
Bobigny, France
Marseille, France
Nantes, France
Szekesfehervar, Hungary
Szombathely, Hungary
Kfar Saba, Israel
Ramat Gan, Israel
Lublin, Poland
Poznan, Poland
Szczecin, Poland
Warszawa, Poland
Russian Federation
Balashikha, Russian Federation
Moscow, Russian Federation
St. Petersburg, Russian Federation
Madrid, Spain
Sevilla, Spain
Kueishan, Taiwan
Taichung, Taiwan
Taipei, Taiwan
Taoyuan, Taiwan
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00404703     History of Changes
Other Study ID Numbers: BO19734
First Posted: November 29, 2006    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2008

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents