Clinical Trial: Study of Bevacizumab Plus Temodar and Tarceva in Patients With Glioblastoma or Gliosarcoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Study of Bevacizumab Plus Temodar and Tarceva After Radiation Therapy and Temodar in Patients With Newly Diagnosed Glioblastoma or Gliosarcoma Who Are Stable Fo

Brief Summary: This is a phase II study of Bevacizumab plus Temodar and Tarceva in patients with non-progressive glioblastoma or gliosarcoma. Patients must have stable disease immediately following a standard course of up-front radiotherapy and Temodar. All patients will receive Bevacizumab, Temodar and Tarceva. A total of 60 patients will be enrolled. Our hypothesis is that the combination of Bevacizumab plus Temodar and Tarceva will increase survival over that seen in historical controls who have newly diagnosed, non-progressive glioblastoma or gliosarcoma following radiotherapy plus Temodar and use Temodar alone.

Detailed Summary: Patients with newly diagnosed glioblastoma or gliosarcoma are treated with standard of care radiation and temozolomide, plus the addition of Bevacizumab and Tarceva. The dose of temozolomide, Bevacizumab and radiation are the same for all patients. Tarceva dose is based upon the use of enzyme inducing anti-epileptic agents. Tarceva is given daily; Bevacizumab is given every 2 weeks; radiation is for 6 weeks, and temozolomide is given daily during radiotherapy and then in the adjuvant setting, is given on a 5-day schedule every 28 days. Patients are followed for progression and survival. The measure of response is MR scanning every 2 months. Dose adjustments are based upon the specific toxicity of the agent in question which differs for each agent (Bevacizumab, temozolomide, or Tarceva). Patients are not randomized, but assigned to an arm based on use of anti-epileptic agents.
Sponsor: University of California, San Francisco

Current Primary Outcome:

  • Overall Survival (OS) [ Time Frame: Approximately 6-24 months ]
    Overall survival was defined from the date of diagnosis to date of death from any cause
  • Unexpected Toxicities During First 2 Cycles of Study Drug [ Time Frame: Within 8 weeks of initiating study therapy ]
    Unexpected severe study-related adverse events


Original Primary Outcome: To determine the overall and progression-free survival for non-progressive patients with newly diagnosed glioblastoma or gliosarcoma treated with Bevacizumab plus Temodar and Tarceva following radiation therapy and Temodar.

Current Secondary Outcome: Progression-free Survival [ Time Frame: Approximately 6 months to 1 year ]

Progression-free survival was defined from the date of diagnosis to the date that progressive disease was first observed on imaging, or the date at which nonreversible neurologic progression or permanently increased corticosteroid requirement, death from any cause, or early discontinuation of treatment. Imaging guidelines were used to evaluate progression: (i) 25% increase in the sum of products of all measurable lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline; (ii) clear worsening of any assessable disease; (iii) appearance of any new lesion/site; and (iv) clear clinical worsening or failure to return for evaluation as a result of death or deteriorating condition (unless clearly unrelated to this cancer).


Original Secondary Outcome: To collect safety data on the combination of Bevacizumab plus Temodar and Tarceva for patients with non-progressive newly diagnosed glioblastoma or gliosarcoma treated with Bevacizumab and Tarceva after radiation therapy and Temodar.

Information By: University of California, San Francisco

Dates:
Date Received: September 4, 2007
Date Started: September 2007
Date Completion:
Last Updated: November 5, 2014
Last Verified: November 2014