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

Hoffmann-La Roche50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-small Cell Lung Cancer

Interventions

BevacizumabDRUG

Bevacizumab was supplied as a sterile liquid in glass vials.

CisplatinDRUG

Bevacizumab was supplied as a sterile liquid in glass vials.

DocetaxelDRUG

Bevacizumab was supplied as a sterile liquid in glass vials.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (14)

Unnamed facility

Palma de Mallorca, Balearic Islands, Spain

Unnamed facility

Cadiz, Cadiz, Spain

Unnamed facility

Castellon, Castellon, Spain

Unnamed facility

Outcomes

Primary Outcomes

Progression-free Survival

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.

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

Secondary Outcomes

Percentage of Participants With an Objective Response

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.

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

Duration of the Objective Response

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

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

Overall Survival

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

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

1-year Survival

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

Time frame: Baseline to 1 year

Data from ClinicalTrials.gov

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