Phase 2
N=27
Bevacizumab in Pats w/ Recurrent ST Brain Metas Who Have Failed Whole Brain Radiation Therapy
Metastatic Cancer · Unspecified Adult Solid Tumor, Protocol Specific
Bottom Line
View on ClinicalTrials.gov: NCT01898130 ↗Enrolled (actual)
27
Serious AEs
70.4%
Results posted
Apr 2019
Primary outcome: Primary: Objective Radiographic Tumor Response in Patients With Recurrent Solid Tumor Brain Metastases Treated With Bevacizumab — 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bevacizumab (Biological); quality-of-life assessment (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Radiographic Tumor Response in Patients With Recurrent Solid Tumor Brain Metastases Treated With Bevacizumab |
2 | — |
| SECONDARY Progression-Free Survival (PFS) at 6 Months in Patients With Recurrent Solid Tumor Brain Metastases Treated With Bevacizumab |
46 | — |
| SECONDARY Time to Progression in Patients With Recurrent Solid Tumor Brain Metastases Treated With Bevacizumab |
300; 187; 525 | — |
| SECONDARY Time to Response in Patients With Recurrent Solid Tumor Brain Metastases Treated With Bevacizumab |
73; 78; 62 | — |
| SECONDARY Duration of Response in Patients With Recurrent Solid Tumor Brain Metastases Treated With Bevacizumab |
227; 110; 463 | — |
| SECONDARY Overall Survival (OS) in Patients With Recurrent Solid Tumor Brain Metastases Treated With Bevacizumab |
8.2 | — |
| SECONDARY Toxicity of Bevacizumab in Patients With Recurrent Solid Tumor Brain Metastases |
1; 1; 3; 1 | — |
| SECONDARY Quality of Life Assessments in Patients With Recurrent Solid Tumor Brain Metastases Treated With Bevacizumab |
83.0; 64.8; 147.8; 106.0; 75.9; 62.8 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients must have a histologically or cytologically confirmed non-central nervous system (CNS) primary solid malignancy at the time of initial diagnosis; NOTE: brain lesions are not required to have pathologic confirmation; in addition, a copy of the pathology report for the primary tumor is sufficient for registration purposes
- Patients must have radiographically-confirmed recurrent brain metastases from a solid tumor after WBRT
- Patients must have measurable or evaluable disease in the brain
- Patients must have been on a stable dose of corticosteroids >= 5 days prior to obtaining their baseline gadolinium (Gd)-MRI of brain
- Patients must have completed WBRT > 12 weeks prior to enrollment to limit cases of pseudoprogression; however if new lesions are noted 4 weeks prior to enrollment, those patients are eligible
- Patients who underwent radiosurgery to treat a progressive lesion must have confirmation of tumor by tissue, magnetic resonance spectroscopy (MRS), magnetic resonance (MR) perfusion or positron emission tomography (PET) and the lesion must be measurable; NOTE: radiosurgery may be done to a lesion that will not be used for response evaluation and should be done > 2 weeks prior to enrollment
- Patients may be on other systemic chemotherapies if progressive CNS disease occurs while on these treatments; NOTE: new systemic chemotherapies should not be started unless required to treat systemic disease and should not start until at least 1 follow up imaging study has been performed
- Patients may have received any number of prior CNS directed therapies - there are no limitations
- Patients must have a life expectancy of >= 12 weeks
- Patients must have a Karnofsky performance score (KPS) of >= 60
- Whole blood cell (WBC) >= 3,000/ul
- Absolute neutrophil count (ANC) >= 1,500/mm^3
- Platelets >= 100,000/mm^3
- Hemoglobin >= 10 gm/dl (may be reached by transfusion)
- Serum glutamic oxaloacetic transaminase (SGOT) 4 weeks from any major surgery
- Patients NOT on warfarin must have a prothrombin time (PT)/international normalized ratio (INR) = 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate = 150 and/or diastolic blood pressure > 100 mmHg) are not eligible for participation
Data sourced from ClinicalTrials.gov (NCT01898130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.