A Phase 2 interventional study of Bevacizumab in Sarcoma, sponsored by Northwestern University. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-25.
Sponsored by Northwestern University · Phase 2, Interventional, and Treatment
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 carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with angiosarcoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 to 4 months for 2 years.
PROJECTED ACCRUAL: A total of 31 patients will be accrued for this study.
99 studies on the registry are indexed under Hemangiosarcoma; 16 are open to participants now.
This study's enrollment of 32 is below the median of 64 across 83 interventional studies indexed under Hemangiosarcoma.
Browse Hemangiosarcoma studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
Compared within Hemangiosarcoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sarcoma. The counts are of registry records indexed under each term, refreshed daily. How we classify →
DISEASE CHARACTERISTICS:
confirmed angiosarcoma
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bevacizumab treatment until disease progression or intolerance
Biological: Bevacizumab
Bevacizumab 15 mg/kg IV infusion given on day 1 every 21 days = (1 cycle).
Also known as: rhuMAb, VEGF, Avastin
Median Progression-free Survival of Patients Treated With the Study Drug as Defined by RECIST Criteria.
During treatment, tumor assessment was done by MRI scan after the second cycle of study treatment, after the forth cycle of study treatment, and then every 3 cycles of treatment thereafter. After Study drug completion, tumor assessment by MRI was done every 3 to 4 months (for up to 2 years after the last bevacizumab dosage). Responses were categorized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
Time frame: After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years.
Objective Response Rate in Patients Treated With Bevacizumab.
Objective response rate will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. Progressive Disease, defined as having at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
Time frame: After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years.
Duration of Response.
During treatment, evaluation of response will be done by MRI scan after the second cycle of study treatment, after the forth cycle of study treatment, and then every 3 cycles of treatment. After Study drug completion, evaluation of response will be assessed by MRI every 3 to 4 months (for 2 years after the last bevacizumab dosage).
Time frame: After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years.
Assess the Treatment Effect of Bevacizumab on Duration of Overall Survival
After Study drug completion, assessment of treatment effect of bevacizumab on duration of overall survival will be assessed by MRI every 3 to 4 months (for 2 years after the last bevacizumab dosage).
Time frame: After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years
Evaluate the Toxicity of Bevacizumab.
Toxicity data for bevacizumab will be collected on day 1 of every cycle (1 cycle = 21 days) during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). In general adverse events (AEs) will be graded according to the following: 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
Time frame: Day 1 of every cycle, on average every 21 days until end of treatment up to 2 years.
The study opened for accrual on June 1, 2005 with an accrual goal of up to 31 patients. The study was designed to enroll 12 patients initially and do an interim efficacy assessment. Accrual was suspended on February 28, 2007 for this analysis and reopened on May 15, 2007. Study was closed to accrual permanently on April 19, 2010.
| Milestone | Bevacizumab |
|---|---|
| Started | 32 |
| Completed | 32 |
| Not completed | 0 |
| Milestone | Bevacizumab |
|---|---|
| Started | 32 |
| Completed | 30 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Physician decision | 1 |
| Milestone | Bevacizumab |
|---|---|
| Started | 30 |
| Completed | 26 |
| Not completed | 4 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Death | 1 |
| Withdrew: Physician decision | 2 |
| Milestone | Bevacizumab |
|---|---|
| Started | 26 |
| Completed | 19 |
| Not completed | 7 |
| Withdrew: Disease progressed | 7 |
| Milestone | Bevacizumab |
|---|---|
| Started | 29 |
| Completed | 3 |
| Not completed | 26 |
| Withdrew: Death | 13 |
| Withdrew: Lost to follow-up | 4 |
| Withdrew: Other | 9 |
During treatment, tumor assessment was done by MRI scan after the second cycle of study treatment, after the forth cycle of study treatment, and then every 3 cycles of treatment thereafter. After Study drug completion, tumor assessment by MRI was done every 3 to 4 months (for up to 2 years after the last bevacizumab dosage). Responses were categorized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
| Weeks | Bevacizumab |
|---|---|
| Median Progression-free Survival of Patients Treated With the Study Drug as Defined by RECIST Criteria. | 12.4 (10.1 to 14.76) |
Objective response rate will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. Progressive Disease, defined as having at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
| Participants | Bevacizumab |
|---|---|
| Partial response | 4 |
| Stable disease | 15 |
| Progressive disease | 11 |
During treatment, evaluation of response will be done by MRI scan after the second cycle of study treatment, after the forth cycle of study treatment, and then every 3 cycles of treatment. After Study drug completion, evaluation of response will be assessed by MRI every 3 to 4 months (for 2 years after the last bevacizumab dosage).
No measurements were reported for this outcome.
After Study drug completion, assessment of treatment effect of bevacizumab on duration of overall survival will be assessed by MRI every 3 to 4 months (for 2 years after the last bevacizumab dosage).
| Weeks | Bevacizumab |
|---|---|
| Assess the Treatment Effect of Bevacizumab on Duration of Overall Survival | 107 (44.29 to 169.99) |
Toxicity data for bevacizumab will be collected on day 1 of every cycle (1 cycle = 21 days) during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). In general adverse events (AEs) will be graded according to the following: 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
| participants | Bevacizumab |
|---|---|
| Participants with one bevacizumab related event | 26 |
| Thromboyctopenia | 4 |
| Shortness of breath | 5 |
| Hypertension | 7 |
| Pain | 3 |
| Nausea | 5 |
| Infection | 2 |
| Headache | 4 |
| Anemia | 6 |
| Decline in FEV1 | 1 |
| Hyperglycemia | 1 |
| Transient ischemic attack | 1 |
| Neuromotor function | 2 |
| Cardiac (congestive heart failure) | 1 |
| Plural effusion | 1 |
| Liver-clinical | 1 |
| Anorexia | 2 |
| Fatigue | 9 |
| Alopecia | 3 |
| Dizziness | 2 |
| Edema | 2 |
| Dementia | 1 |
| Hemorrhage (epitasis) | 1 |
During treatment, tumor assessment was done by MRI scan after the second cycle of study treatment, after the forth cycle of study treatment , and then every 3 cycles of treatment thereafter. After Study drug completion, tumor assessment by MRI was done every 3 to 4 months (for up to 2 years after the last bevacizumab dosage) Responses were categorized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
| Weeks | Bevacizumab |
|---|---|
| Time to Progression | 26 ± 53 |
Collected over Adverse events were collected over a 5 year period.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bevacizumab | 14/30 (46.7%) | 8/30 (26.7%) | 30/30 (100%) |
| Event | Bevacizumab |
|---|---|
| Cardiac ( congestive heart failure)Cardiac disorders | 1/30 |
| PneumoniaInfections and infestations | 1/30 |
| Sinus infectionInfections and infestations | 1/30 |
| Bladder infection (urinary)Infections and infestations | 1/30 |
| FractureMusculoskeletal and connective tissue disorders | 1/30 |
| DizzinessNervous system disorders | 1/30 |
| Speech impairmentNervous system disorders | 1/30 |
| Dyspnea (shortness of breath)Respiratory, thoracic and mediastinal disorders | 1/30 |
| Chest pain (non cardiac)Respiratory, thoracic and mediastinal disorders | 1/30 |
| Knee surgeryMusculoskeletal and connective tissue disorders | 1/30 |
| Event | Bevacizumab |
|---|---|
| FatigueGeneral disorders | 17/30 |
| hypertensionCardiac disorders | 15/30 |
| HeadacheNervous system disorders | 10/30 |
| Hemoglobin (anemia)Blood and lymphatic system disorders | 9/30 |
| NauseaGastrointestinal disorders | 9/30 |
| anorexiaGastrointestinal disorders | 8/30 |
| Alkaline phosphatase increaseMetabolism and nutrition disorders | 8/30 |
| Platelet decreaseBlood and lymphatic system disorders | 7/30 |
| AST, SGPT (serum glutamic oxaloacetic transaminase)Metabolism and nutrition disorders | 7/30 |
| CreatinineMetabolism and nutrition disorders | 7/30 |
| Age, Categorical(Participants) | Bevacizumab |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 16 |
| >=65 years | 16 |
| Sex: Female, Male(Participants) | Bevacizumab |
|---|---|
| Female | 19 |
| Male | 13 |
| Ethnicity (NIH/OMB)(Participants) | Bevacizumab |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 30 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | Bevacizumab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 30 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Bevacizumab |
|---|---|
| United States | 32 |
| Type of Sarcoma(Participants) | Bevacizumab |
|---|---|
| angiosarcoma | 24 |
| epitheliod hemangioendothelioma | 8 |
The record gives a start of Oct 2005, a primary completion of Jun 2013 and a completion of Nov 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2018, 5 years after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bevacizumab