18 and older, any sex, with Metastatic Cancer or Unspecified Adult Solid Tumor, Protocol Specific. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Radiographic Tumor Response in Patients With Recurrent Solid Tumor Brain Metastases Treated With BevacizumabPrimary· Every other cycle, starting cycle 3 (1 cycle =28 days) until off study. Range of cycles completed 1-20.
Radiographic Response to treatment will be assessed prior to every odd-numbered cycle using CT or MRI scans until disease progression, unacceptable toxicity as assessed by the Response Assessment in Neuro-Oncology (RANO) Criteria for target lesions. Response is defined as the number of patients with Complete Response (CR) plus those with Partial Response (PR) radiographically. Generally CR is defined as the disappearance of all target lesions and PR is defined as \>=50% decrease in the sum of the longest diameter of target lesions.
Group
Value
95% CI
Treatment (Bevacizumab)
2
Progression-Free Survival (PFS) at 6 Months in Patients With Recurrent Solid Tumor Brain Metastases Treated With BevacizumabSecondary· At 6 months from treatment initiation.
Progression-Free Survival (PFS) will be measured as the time from the first dose to the first occurrence of progression or death for any reason. To estimate PFS, Kaplan-Meier curves will be calculated and PFS at 6 months will be determined from the progression-free survival curve.
Progression is defined using Response Assessment in Neuro-Oncology Criteria (RANO), as a 25% or more increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Group
Value
95% CI
Treatment (Bevacizumab)
46
25 – 67
Time to Progression in Patients With Recurrent Solid Tumor Brain Metastases Treated With BevacizumabSecondary· From treatment initiation, every 2 cycles (1 cycle = 28 days) until progressive disease. Range of cycles completed 1-20.
MRI or CT scans and clinical assessment will be used to measure Time to Progression which will be assessed as the time from the date of first dose to the date of first observation of progressive disease, non-reversible neurologic progression or increasing steroid requirements, or early discontinuation of treatment as assessed by the RANO Criteria in those patients that experience response.
All Partial Response Patients
Group
Value
95% CI
Treatment (Bevacizumab)
300
91 – 545
Clinical Partial Response
Group
Value
95% CI
Treatment (Bevacizumab)
187
91 – 314
Radiological Partial Response
Group
Value
95% CI
Treatment (Bevacizumab)
525
504 – 545
Time to Response in Patients With Recurrent Solid Tumor Brain Metastases Treated With BevacizumabSecondary· From the start of treatment every 2 cycles (1 cycle =28 days) until time of response. Range of cycles completed 1-20.
MRI or CT scans and clinical assessment will be used to measure Time to Response which will be assessed as the time from the date of first dose to the date of first observed tumor response in all patients that a response is observed. Response to treatment will be assessed using the Response Assessment in Neuro-Oncology (RANO) Criteria for target lesions. Response is defined as either Complete Response (CR) or a Partial Response (PR) radiographically. Generally CR is defined as the disappearance of all target lesions and PR is defined as \>=50% decrease in the sum of the longest diameter of tar
All Partial Response Patients
Group
Value
95% CI
Treatment (Bevacizumab)
73
53 – 116
Clinical Partial Response
Group
Value
95% CI
Treatment (Bevacizumab)
78
53 – 116
Radiological Partial Response
Group
Value
95% CI
Treatment (Bevacizumab)
62
55 – 69
Duration of Response in Patients With Recurrent Solid Tumor Brain Metastases Treated With BevacizumabSecondary· From documentation of response, every two cycles (1 cycle =28 days) until progressive disease. Range of cycles completed 1-20.
The Duration of Overall Response is measured from the time measurement criteria are met for Complete Response (CR) or Partial Response (PR) until the first date that recurrent or Progressive Disease (PD) is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Duration of response will be based on CT or MRI scans and clinical assessment performed prior to every odd-numbered cycle to detect date of first response to study treatment until date of disease progression and assessed by the Response Assessment in Neuro-Onc
All Partial Response Patients
Group
Value
95% CI
Treatment (Bevacizumab)
227
11 – 490
Clinical Partial Response
Group
Value
95% CI
Treatment (Bevacizumab)
110
11 – 119
Radiological Partial Response
Group
Value
95% CI
Treatment (Bevacizumab)
463
435 – 490
Overall Survival (OS) in Patients With Recurrent Solid Tumor Brain Metastases Treated With BevacizumabSecondary· From start of treatment until death from any cause. Median follow up of 8 months (range 1.3 to 47.9 months)
Overall Survival (OS) will be measured as the date of first dose of bevacizumab to the date of death from any cause. To estimate OS, Kaplan-Meier curves will be calculated and OS will be determined from the overall survival curve.
Group
Value
95% CI
Treatment (Bevacizumab)
8.2
4.2 – 12.0
Toxicity of Bevacizumab in Patients With Recurrent Solid Tumor Brain MetastasesSecondary· Assessed prior to every cylcle (cycle=28 days) while on treatment through 30 days post last dose. Range of cycles 1-20.
Adverse events (AE) will be collected at the start of every cycle and graded according NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. All AEs that are determined to be grade 3 or higher and at least possible related to bevacizumab will be reported for toxicity. In general AEs will be graded:
Grade 1 - Mild: the event causes discomfort without disruption of normal daily activities.
Grade 2 - Moderate: the event causes discomfort that affects normal daily activities.
Grade 3 - Severe: the event makes the patient unable to perform normal daily activities or significan
Lymphocyte Count Decreased
Group
Value
95% CI
Treatment (Bevacizumab)
1
Headache
Group
Value
95% CI
Treatment (Bevacizumab)
1
Hypertension
Group
Value
95% CI
Treatment (Bevacizumab)
3
Thromboembolic Event
Group
Value
95% CI
Treatment (Bevacizumab)
1
Quality of Life Assessments in Patients With Recurrent Solid Tumor Brain Metastases Treated With BevacizumabSecondary· Baseline and at Cycle 3 (1 Cycle = 28 days).
Changes in quality of life will be evaluated using questionnaires (FACT-Br) at baseline (before treatment initiation) and at cycle 3.
Four FACT scales were calculated. The higher the value the better the score, i.e., the better the quality of life perceived by patient.
FACT-G (Fact General, possible range 0 - 108) BrCS (Brain Cancer Subscale, possible range 0 - 92) TOTAL (FACT-G + BrCS, possible range 0 - 200) TOI (Trial Outcome Index = Physical Well Being \_ Functional Well Being +BrCS, possible range 0 - 148)
Baseline FACT-G
Group
Value
95% CI
Treatment (Bevacizumab)
83.0
67.7 – 105.0
Baseline BrCS
Group
Value
95% CI
Treatment (Bevacizumab)
64.8
46.0 – 87.0
Baseline TOTAL
Group
Value
95% CI
Treatment (Bevacizumab)
147.8
124.3 – 189.0
Baseline TOI
Group
Value
95% CI
Treatment (Bevacizumab)
106.0
77.0 – 139.0
Cycle 3 FACT-G
Group
Value
95% CI
Treatment (Bevacizumab)
75.9
50.8 – 99.0
Cycle 3 BrCS
Group
Value
95% CI
Treatment (Bevacizumab)
62.8
36.1 – 80.0
Cycle 3 TOTAL
Group
Value
95% CI
Treatment (Bevacizumab)
138.7
93.8 – 178.0
Cycle 3 TOI
Group
Value
95% CI
Treatment (Bevacizumab)
99.4
57.1 – 130.0
Response Rate in Patients With Recurrent Solid Tumor Brain Metastases Treated With BevacizumabSecondary· Every other cycle, starting cycle 3 (1 cycle =28 days) until off study. Range of cycles completed 1-20.
Response Rate is defined as all patients with Complete Response plus those with Partial Response as assessed by Response Assessment in Neuro-Oncology (RANO) Criteria of CT or MRI scans for target lesions combined with clinical assessment. Generally RANO Response definitions are as follows:
CR is defined as the disappearance of all target lesions and PR is defined as \>=50% decrease in the sum of the longest diameter of target lesions.
Group
Value
95% CI
Treatment (Bevacizumab)
6
Progression Free Survival (PFS) in Patients With Recurrent Solid Tumor Brain Metastases Treated With BevacizumabSecondary· From treatment initiation and every two cycles (1 cycle = 28 days) until disease progression. Median follow up of 8 months (range 1.3 to 47.9 months).
Progression Free Survival (PFS) is measured from the time of treatment initiation until documentation of progressive disease or death from any cause. To estimate PFS, Kaplan-Meier curves will be calculated and PFS will be determined from the progression-free survival curve.
Progression is defined using Response Assessment in Neuro-Oncology Criteria (RANO), as a 25% or more increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Group
Value
95% CI
Treatment (Bevacizumab)
4.3
3.3 – 7.7
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events were collected from the start of treatment, through 30 days post last treatment with patients being treated twice (every 14 days) in a 28 day cycle. Range of cycles completed 1-20..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment (Bevacizumab)
Serious: 19/27 (70%)
Deaths: 24/27
Serious adverse events (21 terms)
Reaction
System
Treatment (Bevacizumab)
Disease Progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Seizure
Nervous system disorders
—
Clinical Decline
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This is a study to evaluate a drug called bevacizumab in patients with cancer whose disease has spread to their brain. This study will not evaluate the effect of bevacizumab on the systemic solid tumor cancer. Bevacizumab is a medication and it is thought that bevacizumab may interfere with the growth of new blood vessels; therefore it might stop tumor growth and possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood vessels.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Northwestern University
Last refreshed: 17 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01898130.