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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661778
• Other study ID #: ML20081
• Secondary ID: 2006-005619-88
• Status: Completed
• Phase: Phase 2
• First received: April 17, 2008
• Last updated: July 9, 2014
• Start date: July 2007
• Est. completion date: July 2011

Study information

• Verified date: July 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Bevacizumab
Bevacizumab was supplied as a sterile liquid in glass vials.
• Cisplatin
Bevacizumab was supplied as a sterile liquid in glass vials.
• Docetaxel
Bevacizumab was supplied as a sterile liquid in glass vials.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to the end of the study (up to 4 years)	No
Secondary	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.	Baseline to the end of the study (up to 4 years)	No
Secondary	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.	Baseline to the end of the study (up to 4 years)	No
Secondary	Overall Survival	Overall survival is defined as the time from the first dose of study medication until death.	Baseline to the end of the study (up to 4 years)	No
Secondary	1-year Survival	The probability of surviving 1 year was estimated using the Kaplan-Meier method.	Baseline to 1 year	No