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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00404703 |
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 |
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
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
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 |
Health Authority: | Belgium: Ministry of Social Affairs, Public Health and the Environment |
Thoracic Neoplasms Non-small cell lung cancer Carboplatin Bevacizumab Hemorrhage Recurrence Carcinoma Cisplatin |
Respiratory Tract Diseases Lung Neoplasms Paclitaxel Lung Diseases Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses |
Growth Substances Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |