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OpenTrials
Completed

NCT Number: NCT00661778

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 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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Palma de Mallorca, Balearic Islands, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Bevacizumab

Drug

Bevacizumab was supplied as a sterile liquid in glass vials.

Other names: Avastin

Cisplatin

Drug

Bevacizumab was supplied as a sterile liquid in glass vials.

docetaxel

Drug

Bevacizumab was supplied as a sterile liquid in glass vials.

Other names: Taxotere

Primary outcomes

  1. Progression-free Survival

    Time frame: Baseline to the end of the study (up to 4 years)

    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 outcomes

  1. Percentage of Participants With an Objective Response

    Time frame: Baseline to the end of the study (up to 4 years)

    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.

  2. Duration of the Objective Response

    Time frame: Baseline to the end of the study (up to 4 years)

    Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.

  3. Overall Survival

    Time frame: Baseline to the end of the study (up to 4 years)

    Overall survival is defined as the time from the first dose of study medication until death.

  4. 1-year Survival

    Time frame: Baseline to 1 year

    The probability of surviving 1 year was estimated using the Kaplan-Meier method.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Apr 18, 2008
Registry last updated
Jul 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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