Study of Bevacizumab Plus Temodar and Tarceva in Patients With Glioblastoma or Gliosarcoma (AVF4120s)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Michael Prados, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00525525
First received: September 4, 2007
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Glioblastoma
Gliosarcoma
Drug: Avastin
Drug: Tarceva
Drug: Temodar
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Following Radiation

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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. [ Time Frame: Approximately 6 months to 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Approximately 6 months to 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: September 2007
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Avastin
    Patients are given 10 mg/kg IV Q2 weeks.
    Other Name: Bevacizumab
    Drug: Tarceva
    Patients receive 150 mg PO daily. If patients are not experiencing intolerable toxicity, they may escalate their dose to 200 mg PO daily. If patients are experiencing intolerable toxicity, their dose will be held until the toxicity improves or resolves, then re-treated at a lower dose level, i.e. 100 mg PO daily.
    Other Name: Erlotonib
    Drug: Temodar
    Patients receive 200 mg/m2 for Days 1-5 of every 28 day cycle. Although the calendar days may be slightly altered, the patient should always receive this dose for 5 days within a treatment cycle. If the patient experiences certain toxicities specified in the protocol, Temodar will be held then given at a reduced dose, i.e. 150 mg/m2 Days 1-5.
    Other Name: Temozolomide
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologically proven, non-progressive glioblastoma multiforme (GBM) or gliosarcoma (GS) with stable disease immediately following XRT + TMZ. All patients will receive Bevacizumab plus Tarceva and TMZ.
  • Biopsy or resection must have been performed prior to RT + TMZ.
  • No chemotherapy is allowed prior to starting RT + TMZ, including Gliadel Wafers.
  • Patients will have started RT + TMZ prior to registration and study entry and are eligible as long as they do not have progressive disease and can start Bevacizumab + TMZ and Tarceva within 4 weeks after the completion of RT + TMZ. Patients MUST have been treated with at least 54 Gy radiotherapy (60 Gy recommended) and MUST have received Temodar concurrently with radiotherapy for eligibility for this study.
  • Patients may or may not have measurable or evaluable disease on contrast MR imaging. A post-radiotherapy MRI scan must document stable disease.
  • Patients must be > 18 years old and with a life expectancy > 12 weeks.
  • Patients must have a Karnofsky performance status of > 70.
  • Patients must have adequate bone marrow function (WBC > 3,000/µl, ANC > 1,500/mm3, platelet count of > 100,000/mm3, and hemoglobin > 10 mg/dl), adequate liver function (SGOT and bilirubin < 1.5 times ULN), and adequate renal function (creatinine < 1.5 mg/dL) before starting therapy. These tests must be performed within 14 days prior to initial treatment.

Exclusion Criteria:

  • Patients must not have evidence of recent hemorrhage on baseline MRI of the brain, with the following exceptions: presence of hemosiderin, resolving hemorrhage changes related to surgery, presence of punctuate hemorrhage in the tumor.
  • Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the patient's ability to tolerate this therapy or any disease that will obscure toxicity or dangerously alter drug metabolism.
  • Patients must not have proteinuria at screening as demonstrated by either

    • Urine protein: creatinine (UPC) ratio ³ 1.0 at screening OR
    • Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).
  • Patients must not have inadequately controlled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure > 100 mmHg) on antihypertensive medications.
  • Patients must not have any prior history of hypertensive crisis or hypertensive encephalopathy.
  • Patients must not have New York Heart Association Grade II or greater congestive heart failure (see Appendix E).
  • Patients must not have history of myocardial infarction or unstable angina within 12 months prior to study enrollment.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00525525

Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Michael D. Prados, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Michael Prados, Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00525525     History of Changes
Obsolete Identifiers: NCT00535249
Other Study ID Numbers: 07105, unknown
Study First Received: September 4, 2007
Last Updated: May 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
Glioblastoma
Gliosarcoma
Bevacizumab
Avastin
Erlotinib
Tarceva
Temozolomide
Temodar

Additional relevant MeSH terms:
Glioblastoma
Gliosarcoma
Astrocytoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Bevacizumab
Erlotinib
Temozolomide
Alkylating Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014