Study of Bevacizumab Plus Temodar and Tarceva in Patients With Glioblastoma or Gliosarcoma
Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glioblastoma; Gliosarcoma
Intervention: Bevacizumab (Drug); Tarceva (Drug); Temozolomide (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of California, San Francisco Official(s) and/or principal investigator(s): Michael D. Prados, MD, Principal Investigator, Affiliation: University of California, San Francisco
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.
Clinical Details
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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Overall Survival (OS)Unexpected Toxicities During First 2 Cycles of Study Drug
Secondary outcome: Progression-free Survival
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
University of California San Francisco, San Francisco, California 94143, United States
Additional Information
Starting date: September 2007
Last updated: November 5, 2014
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