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Status:

COMPLETED

Bevacizumab and Erlotinib After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma

Lead Sponsor:

Northwestern University

Collaborating Sponsors:

M.D. Anderson Cancer Center

Conditions:

Brain and Central Nervous System Tumors

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: 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...

Detailed Description

OBJECTIVES: Primary * To determine the overall survival of patients with newly diagnosed glioblastoma multiforme (GBM) with unmethylated MGMT promoter treated with bevacizumab and erlotinib hydrochl...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed newly diagnosed glioblastoma multiforme (GBM) or gliosarcoma
  • Undergoing or plan to undergo treatment with radiotherapy and concurrent temozolomide for 6 weeks
  • Unmethylated MGMT promoter status must be determined before completing radiotherapy
  • Tumor must be MGMT negative to receive bevacizumab and erlotinib hydrochloride
  • Patients who are post biopsy or tumor resection allowed provided a post-operative MRI is done no more than 96 hours after surgery (in order for an accurate assessment to be done post radiotherapy):
  • Evaluable or measurable disease after resection of recurrent tumor is not mandated for eligibility
  • Patients who started radiotherapy and temozolomide prior to study entry are eligible as long as the gene methylation status is determined before starting bevacizumab and erlotinib hydrochloride
  • Radiotherapy plans need to be verified to confirm the treatment plan meets the study requirement based on the PI assessment
  • No progressive disease based on MRI or CT scan per the investigators assessment
  • PATIENT CHARACTERISTICS:
  • Karnofsky performance status 70-100%
  • Life expectancy \> 12 weeks
  • WBC \> 3,000/μL
  • ANC \> 1,500/mm³
  • Platelet count \> 100,000/mm³
  • Hemoglobin \> 10 g/dL
  • SGOT/SGPT \< 3 times upper limit of normal (ULN)
  • Bilirubin \< 3 times ULN
  • Creatinine \< 1.5 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • No significant medical illness 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
  • No proteinuria at screening, as demonstrated by either of the following:
  • Urine protein:creatinine (UPC) ratio \< 1.0
  • Urine dipstick for proteinuria \< 2+ OR ≤ 1g protein by 24-hour urine collection
  • No inadequately controlled hypertension (defined as systolic blood pressure \> 150 mm Hg and/or diastolic blood pressure \> 100 mm Hg) on antihypertensive medications
  • No history of hypertensive crisis or hypertensive encephalopathy
  • No New York Heart Association class II-IV congestive heart failure
  • No history of myocardial infarction or unstable angina within 6 months prior to study enrollment
  • No history of stroke or transient ischemic attack within 6 months of study enrollment
  • No symptomatic peripheral vascular disease
  • No significant vascular disease (i.e., aortic aneurysm or aortic dissection)
  • No evidence of bleeding diathesis or coagulopathy
  • No significant traumatic injury within 28 days prior to study enrollment
  • No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
  • No serious, nonhealing wound, ulcer, or bone fracture
  • No known HIV positivity
  • HIV testing is not required for study participation
  • No history of any other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years
  • PRIOR CONCURRENT THERAPY:
  • No chemotherapy is allowed prior to starting radiotherapy and temozolomide, including polifeprosan 20 with carmustine implant (Gliadel wafers)
  • No major surgical procedure or open biopsy within 28 days prior to study enrollment or the anticipation of need for major surgical procedure during the course of the study
  • No core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
  • Concurrent nonenzyme-inducing anticonvulsants allowed
  • More than 2 weeks (before starting erlotinib hydrochloride and bevacizumab) since prior and no concurrent enzyme-inducing anticonvulsant
  • No other concurrent experimental agents
  • Not concurrently participating in other clinical trials

Exclusion

    Key Trial Info

    Start Date :

    July 7 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 5 2018

    Estimated Enrollment :

    115 Patients enrolled

    Trial Details

    Trial ID

    NCT00720356

    Start Date

    July 7 2009

    End Date

    July 5 2018

    Last Update

    October 26 2018

    Active Locations (9)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (9 locations)

    1

    Cedars-Sinai Medical Center

    Los Angeles, California, United States, 90048

    2

    M.D. Anderson Cancer Center at Orlando

    Orlando, Florida, United States, 32806-2134

    3

    Northwestern University, Northwestern Medical Faculty Foundation

    Chicago, Illinois, United States, 60611-3013

    4

    Evanston Hospital

    Evanston, Illinois, United States, 60201-1781