Trial Outcomes & Findings for Bevacizumab in Treating Patients With Recurrent or Progressive Glioma (NCT NCT00337207)

Last Updated: 2020-02-07

Results Overview

Safety of treatment will be defined by the number of patients that experience grade 3 and 4 adverse events where causal relationship with bevacizumab cannot be completely ruled out. Adverse events will be graded using Common Terminology Criteria for Adverse Events v3.0 (CTCAE) where: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

55 participants

Primary outcome timeframe

From treatment initiation, throughout treatment and up to 30 days post-treatment, for up to 1 year.

Results posted on

2020-02-07

Participant Flow

Patients were recruited from the Neuro-Oncology outpatient clinic and inpatient services between the dates of March 16, 2006 and June 5, 2008.

Participant milestones

Participant milestones
Measure	Study Treatment All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
Overall Study STARTED	55
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Study Treatment All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Bevacizumab in Treating Patients With Recurrent or Progressive Glioma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Treatment n=55 Participants All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	51.91 years STANDARD_DEVIATION 12.14 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants
Diagnosis Glioblastoma multiforme (GBM)	44 Participants n=5 Participants
Diagnosis Anaplastic astrocytoma (AA)	7 Participants n=5 Participants
Diagnosis Gliosarcoma	0 Participants n=5 Participants
Diagnosis Anaplastic oligodendronglioma	4 Participants n=5 Participants
Diagnosis Anaplastic mixed glioma	0 Participants n=5 Participants
Diagnosis Malignant glioma NOS (not otherwise specified)	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From treatment initiation, throughout treatment and up to 30 days post-treatment, for up to 1 year.

Population: All patients that receive at least one dose of study treatment are evaluable for toxicity

Outcome measures

Outcome measures
Measure	Bevacizumab Treatment n=55 Participants All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
Safety of Treatment Bowel perforation	1 participants
Safety of Treatment DVT	1 participants
Safety of Treatment Fatigue	5 participants
Safety of Treatment Headache	1 participants
Safety of Treatment Lack of drive	1 participants
Safety of Treatment Rectal bleeding	2 participants

PRIMARY outcome

Timeframe: After all patients have surpassed the 6 month post-treatment timepoint

Population: 1 patient became deceased due to toxicity prior to the 6 month time point and thus, was not evaluable for the 6 month progression free survival endpoint.

The number of patients experiencing progression free survival (PFS) was calculated at the 6-month time point.

Outcome measures

Outcome measures
Measure	Bevacizumab Treatment n=54 Participants All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
Progression-free Survival at 6 Months # of Patients Experiencing PFS at 6 months	13 Participants
Progression-free Survival at 6 Months # of Patients Who Progressed Prior to 6 months	41 Participants

PRIMARY outcome

Timeframe: Before and after treatment

Population: This was an optional outcome measure. Data was not collected or analyzed for this outcome measure.

To assess changes in tumoral blood flow based on MR Perfusion and tissue changes by MR spectroscopy.

Outcome measures

Outcome data not reported

Adverse Events

Study Treatment

Serious events: 9 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Study Treatment n=55 participants at risk All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
Gastrointestinal disorders Hemorrhage - GI (rectal)	1.8% 1/55 • Number of events 1 • From time of first study treatment up to 30 days after the last dose (total time frame was variable by patient). All patients were evaluable for toxicity from the time of their first treatment with bevacizumab. Patients continued on treatment until disease progression or unacceptable toxicity, thus the evaluation period was different for each patient.
Gastrointestinal disorders Perforation - GI (bowel)	1.8% 1/55 • Number of events 1 • From time of first study treatment up to 30 days after the last dose (total time frame was variable by patient). All patients were evaluable for toxicity from the time of their first treatment with bevacizumab. Patients continued on treatment until disease progression or unacceptable toxicity, thus the evaluation period was different for each patient.
General disorders Fatigue	9.1% 5/55 • Number of events 5 • From time of first study treatment up to 30 days after the last dose (total time frame was variable by patient). All patients were evaluable for toxicity from the time of their first treatment with bevacizumab. Patients continued on treatment until disease progression or unacceptable toxicity, thus the evaluation period was different for each patient.
Vascular disorders Thrombosis/embolism (venous)	1.8% 1/55 • Number of events 1 • From time of first study treatment up to 30 days after the last dose (total time frame was variable by patient). All patients were evaluable for toxicity from the time of their first treatment with bevacizumab. Patients continued on treatment until disease progression or unacceptable toxicity, thus the evaluation period was different for each patient.
General disorders Death due to disease progression	5.5% 3/55 • Number of events 3 • From time of first study treatment up to 30 days after the last dose (total time frame was variable by patient). All patients were evaluable for toxicity from the time of their first treatment with bevacizumab. Patients continued on treatment until disease progression or unacceptable toxicity, thus the evaluation period was different for each patient.

Other adverse events

Other adverse events
Measure	Study Treatment n=55 participants at risk All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
General disorders Fatigue	49.1% 27/55 • Number of events 27 • From time of first study treatment up to 30 days after the last dose (total time frame was variable by patient). All patients were evaluable for toxicity from the time of their first treatment with bevacizumab. Patients continued on treatment until disease progression or unacceptable toxicity, thus the evaluation period was different for each patient.
Vascular disorders Hemorrhage	27.3% 15/55 • Number of events 15 • From time of first study treatment up to 30 days after the last dose (total time frame was variable by patient). All patients were evaluable for toxicity from the time of their first treatment with bevacizumab. Patients continued on treatment until disease progression or unacceptable toxicity, thus the evaluation period was different for each patient.
Cardiac disorders Hypertension	21.8% 12/55 • Number of events 12 • From time of first study treatment up to 30 days after the last dose (total time frame was variable by patient). All patients were evaluable for toxicity from the time of their first treatment with bevacizumab. Patients continued on treatment until disease progression or unacceptable toxicity, thus the evaluation period was different for each patient.
General disorders Pain - headache	18.2% 10/55 • Number of events 10 • From time of first study treatment up to 30 days after the last dose (total time frame was variable by patient). All patients were evaluable for toxicity from the time of their first treatment with bevacizumab. Patients continued on treatment until disease progression or unacceptable toxicity, thus the evaluation period was different for each patient.
Infections and infestations Infection	16.4% 9/55 • Number of events 9 • From time of first study treatment up to 30 days after the last dose (total time frame was variable by patient). All patients were evaluable for toxicity from the time of their first treatment with bevacizumab. Patients continued on treatment until disease progression or unacceptable toxicity, thus the evaluation period was different for each patient.
Skin and subcutaneous tissue disorders Rash	20.0% 11/55 • Number of events 11 • From time of first study treatment up to 30 days after the last dose (total time frame was variable by patient). All patients were evaluable for toxicity from the time of their first treatment with bevacizumab. Patients continued on treatment until disease progression or unacceptable toxicity, thus the evaluation period was different for each patient.
Nervous system disorders Memory impairment	12.7% 7/55 • Number of events 7 • From time of first study treatment up to 30 days after the last dose (total time frame was variable by patient). All patients were evaluable for toxicity from the time of their first treatment with bevacizumab. Patients continued on treatment until disease progression or unacceptable toxicity, thus the evaluation period was different for each patient.
Nervous system disorders Neuropathy - motor	5.5% 3/55 • Number of events 3 • From time of first study treatment up to 30 days after the last dose (total time frame was variable by patient). All patients were evaluable for toxicity from the time of their first treatment with bevacizumab. Patients continued on treatment until disease progression or unacceptable toxicity, thus the evaluation period was different for each patient.
Nervous system disorders Neuropathy - sensory	5.5% 3/55 • Number of events 3 • From time of first study treatment up to 30 days after the last dose (total time frame was variable by patient). All patients were evaluable for toxicity from the time of their first treatment with bevacizumab. Patients continued on treatment until disease progression or unacceptable toxicity, thus the evaluation period was different for each patient.
Psychiatric disorders Personality/behavioral	9.1% 5/55 • Number of events 5 • From time of first study treatment up to 30 days after the last dose (total time frame was variable by patient). All patients were evaluable for toxicity from the time of their first treatment with bevacizumab. Patients continued on treatment until disease progression or unacceptable toxicity, thus the evaluation period was different for each patient.
Blood and lymphatic system disorders Anemia	10.9% 6/55 • Number of events 6 • From time of first study treatment up to 30 days after the last dose (total time frame was variable by patient). All patients were evaluable for toxicity from the time of their first treatment with bevacizumab. Patients continued on treatment until disease progression or unacceptable toxicity, thus the evaluation period was different for each patient.
Gastrointestinal disorders Nausea	7.3% 4/55 • Number of events 4 • From time of first study treatment up to 30 days after the last dose (total time frame was variable by patient). All patients were evaluable for toxicity from the time of their first treatment with bevacizumab. Patients continued on treatment until disease progression or unacceptable toxicity, thus the evaluation period was different for each patient.
Metabolism and nutrition disorders Elevated transaminases - AST/ALT	16.4% 9/55 • Number of events 9 • From time of first study treatment up to 30 days after the last dose (total time frame was variable by patient). All patients were evaluable for toxicity from the time of their first treatment with bevacizumab. Patients continued on treatment until disease progression or unacceptable toxicity, thus the evaluation period was different for each patient.
General disorders Weight loss	7.3% 4/55 • Number of events 4 • From time of first study treatment up to 30 days after the last dose (total time frame was variable by patient). All patients were evaluable for toxicity from the time of their first treatment with bevacizumab. Patients continued on treatment until disease progression or unacceptable toxicity, thus the evaluation period was different for each patient.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.5% 3/55 • Number of events 3 • From time of first study treatment up to 30 days after the last dose (total time frame was variable by patient). All patients were evaluable for toxicity from the time of their first treatment with bevacizumab. Patients continued on treatment until disease progression or unacceptable toxicity, thus the evaluation period was different for each patient.
Musculoskeletal and connective tissue disorders Pain - arthralgia	5.5% 3/55 • Number of events 3 • From time of first study treatment up to 30 days after the last dose (total time frame was variable by patient). All patients were evaluable for toxicity from the time of their first treatment with bevacizumab. Patients continued on treatment until disease progression or unacceptable toxicity, thus the evaluation period was different for each patient.
General disorders Pain - Not otherwise specified	5.5% 3/55 • Number of events 3 • From time of first study treatment up to 30 days after the last dose (total time frame was variable by patient). All patients were evaluable for toxicity from the time of their first treatment with bevacizumab. Patients continued on treatment until disease progression or unacceptable toxicity, thus the evaluation period was different for each patient.
Renal and urinary disorders Renal - Other (hematuria)	5.5% 3/55 • Number of events 3 • From time of first study treatment up to 30 days after the last dose (total time frame was variable by patient). All patients were evaluable for toxicity from the time of their first treatment with bevacizumab. Patients continued on treatment until disease progression or unacceptable toxicity, thus the evaluation period was different for each patient.

Additional Information

Clinical Research Office Administrator

Northwestern University

Phone: 312-695-1301

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place