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

This study has been terminated.
(Primary (safety) endpoint reached)
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00404703
First received: November 28, 2006
Last updated: August 26, 2008
Last verified: August 2008
  Purpose

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 Intervention Phase
Non-Small Cell Lung Cancer
Drug: bevacizumab [Avastin]
Drug: Platinum-based chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Rate of grade >=3 Avastin-related pulmonary hemorrhage [ Time Frame: After a maximum of 12 months treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall response, duration of response, progression-free survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, coagulation parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Estimated Study Completion Date: March 2008
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
15mg iv on day 1 of each 3 week cycle
Drug: Platinum-based chemotherapy
As prescribed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404703

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

No publications provided

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00404703     History of Changes
Other Study ID Numbers: BO19734
Study First Received: November 28, 2006
Last Updated: August 26, 2008
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

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

ClinicalTrials.gov processed this record on August 19, 2014