A Study of Avastin (Bevacizumab) in Combination With Docetaxel and Cisplatin in Patients With Metastatic or Locally Advanced Non-Small Cell Lung Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00661778
First received: April 17, 2008
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

This study will assess the efficacy and safety of Avastin in combination with docetaxel and cisplatin as first-line treatment of patients with metastatic or locally advanced non-small cell lung cancer. Patients will receive Avastin 15mg/kg i.v., docetaxel 75mg/kg and cisplatin 75mg/m2 on day 1 of each 3 week cycle, for a maximum of 6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: bevacizumab [Avastin]
Drug: docetaxel
Drug: cisplatin
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 to Assess the Effect of First-line Treatment With Avastin in Combination With Docetaxel and Cisplatin on Progression-free Survival in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of survival; response rate [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, lab parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: July 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
15mg/kg iv on day 1 of each 3 week cycle
Drug: docetaxel
75mg/kg iv on day 1 of each 3 week cycle
Drug: cisplatin
75mg/m2 iv on day 1 of each 3 week cycle

  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;
  • stage IIIb or IV non-small cell lung cancer;
  • chemotherapy-naive.

Exclusion Criteria:

  • previous treatment for non-small cell lung cancer;
  • previous malignant tumor within last 5 years, except for basal cell skin cancer or preinvasive cervical cancer;
  • major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to start of study;
  • recent or current chronic treatment with aspirin (>325mg/day).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00661778

Locations
Spain
Cádiz, Cadiz, Spain, 11009
San Sebastian, Guipuzcoa, Spain, 20080
Palma de Mallorca, Islas Baleares, Spain, 07198
Alcala de Henares, Madrid, Spain, 28805
Sagunto, Valencia, Spain, 46520
Castellon, Spain, 12002
Madrid, Spain, 28935
Madrid, Spain, 28036
Malaga, Spain, 29010
Palencia, Spain, 34005
Valencia, Spain, 46017
Valladolid, Spain, 47010
Valladolid, Spain, 47005
Zamora, Spain, 49021
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00661778     History of Changes
Other Study ID Numbers: ML20081, 2006-005619-88
Study First Received: April 17, 2008
Last Updated: October 7, 2013
Health Authority: Spain: Ministry of Health

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
Docetaxel
Bevacizumab
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on April 14, 2014