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 )

First Received: November 28, 2006 Last Updated: August 26, 2008 History of Changes

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00404703

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Bevacizumab

U.S. FDA Resources

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
1: Experimental	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

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

St. Petersburg, Russian Federation

Moscow, Russian Federation

Balashikha, 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, +1 973 235 5000

More Information

No publications provided

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

Study placed in the following topic categories:

Thoracic Neoplasms
Carboplatin
Bevacizumab
Hemorrhage
Angiogenesis Inhibitors
Recurrence
Carcinoma
Cisplatin

Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel
Lung Diseases
Non-small Cell Lung Cancer
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Bevacizumab
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma

Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 03, 2009