Clinical Trial: S0635: Erlotinib and Bevacizumab in Stage IIIB and IV Bronchioloalveolar Carcinoma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase II Trial of the Combination of OSI-774 (ERLOTINIB; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) an

Brief Summary:

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab works in treating patients with stage III or stage IV non-small cell lung cancer.


Detailed Summary:

OBJECTIVES:

Primary

  • Determine overall survival of patients with stage IIIB or IV bronchioloalveolar carcinoma (BAC) or adenocarcinoma with BAC features treated with erlotinib hydrochloride and bevacizumab.

Secondary

  • Determine the progression-free survival of patients treated with this regimen.
  • Compare, preliminarily, response as assessed by RECIST criteria vs response as assessed by a central computer-assisted image-analysis system in patients with measurable disease treated with this regimen.
  • Assess the frequency and severity of toxicities of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib hydrochloride once daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 2 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.


Sponsor: Southwest Oncology Group

Current Primary Outcome: Overall Survival [ Time Frame: From date of registration to maximum of 3 years ]

Original Primary Outcome: Overall Survival

Current Secondary Outcome:

  • Progression-free Survival [ Time Frame: From date of registration to maximum of 3 years ]
  • Response as Assessed by RECIST Criteria vs Central Computer-assisted Image-analysis System in Patients With Measurable Disease [ Time Frame: From date of registration to maximum of 3 years ]
    Images for response assessed by the central computer-assisted image-analysis system were never collected.
  • Frequency and Severity of Toxicities [ Time Frame: From date of registration to maximum of 3 years ]


Original Secondary Outcome:

  • Progression-free Survival
  • Response as Assessed by RECIST Criteria vs Central Computer-assisted Image-analysis System in Patients With Measurable Disease
  • Toxicity


Information By: Southwest Oncology Group

Dates:
Date Received: February 15, 2007
Date Started: July 2007
Date Completion:
Last Updated: January 10, 2017
Last Verified: January 2017