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

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

MedlinePlus related topics:

Cancer Lung Cancer

ChemIDplus related topics:

Carboplatin Cisplatin Gemcitabine hydrochloride Gemcitabine Paclitaxel Bevacizumab

U.S. FDA Resources

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

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

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BO19734
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

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on September 23, 2008

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