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: July 9, 2014
Last verified: July 2014
  Purpose

This study assessed 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 received Avastin 15 mg/kg intravenously (IV), docetaxel 75 mg/m^2, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle for a maximum of 6 cycles.


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: Bevacizumab
Drug: Cisplatin
Drug: Docetaxel
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: Baseline to the end of the study (up to 4 years) ] [ Designated as safety issue: No ]
    Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.


Secondary Outcome Measures:
  • Percentage of Participants With an Objective Response [ Time Frame: Baseline to the end of the study (up to 4 years) ] [ Designated as safety issue: No ]
    An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.

  • Duration of the Objective Response [ Time Frame: Baseline to the end of the study (up to 4 years) ] [ Designated as safety issue: No ]
    Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.

  • Overall Survival [ Time Frame: Baseline to the end of the study (up to 4 years) ] [ Designated as safety issue: No ]
    Overall survival is defined as the time from the first dose of study medication until death.

  • 1-year Survival [ Time Frame: Baseline to 1 year ] [ Designated as safety issue: No ]
    The probability of surviving 1 year was estimated using the Kaplan-Meier method.


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: Bevacizumab + cisplatin + docetaxel
Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
Drug: Bevacizumab
Bevacizumab was supplied as a sterile liquid in glass vials.
Other Name: Avastin
Drug: Cisplatin
Bevacizumab was supplied as a sterile liquid in glass vials.
Drug: Docetaxel
Bevacizumab was supplied as a sterile liquid in glass vials.
Other Name: Taxotere

  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 (> 325 mg/day).
  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: 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
Results First Received: May 27, 2014
Last Updated: July 9, 2014
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
Bevacizumab
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014