Trial · NCT00288015
Bevacizumab in Treating Patients With Angiosarcoma
NCT00288015, Phase 2, Completed, Northwestern University; results first posted 2018-06-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bevacizumab in Treating Patients With Angiosarcoma. Trials, record NCT00288015. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00288015
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bevacizumab in Treating Patients With Angiosarcoma
- NCT number
- NCT00288015
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 32 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Sarcoma
- Interventions
- Bevacizumab
- First posted
- 2006-02-07
- Last updated
- 2018-06-25
- Results first posted
- 2018-06-25
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Progression-free Survival of Patients Treated With the Study Drug as Defined by RECIST Criteria. | 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. | 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. |
| Secondary | Objective Response Rate in Patients Treated With Bevacizumab. | 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 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. |
| Secondary | Duration of Response. | 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. | 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). |
| Secondary | Assess the Treatment Effect of Bevacizumab on Duration of Overall Survival | 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 | 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). |
| Secondary | Evaluate the Toxicity of Bevacizumab. | Day 1 of every cycle, on average every 21 days until end of treatment up to 2 years. | 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 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Progression-free Survival of Patients Treated With the Study Drug as Defined by RECIST Criteria. | 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. | Weeks | MEDIAN | |
| SECONDARY | Objective Response Rate in Patients Treated With Bevacizumab. | 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. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Response. | 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. | Data for this outcome measure was not collected. By the time the results of the study were being collected, this outcome measure was no longer relevant as Recist 1.0 was in use. As a result, data for this outcome measure was not collected or analysed. Time to progression was a more relevant data point. | ||
| SECONDARY | Assess the Treatment Effect of Bevacizumab on Duration of Overall Survival | 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 | Weeks | MEDIAN | |
| SECONDARY | Evaluate the Toxicity of Bevacizumab. | Day 1 of every cycle, on average every 21 days until end of treatment up to 2 years. | Number of participants with either grade 1 (mild), 2 (moderate),3 (severe), 4 (life-threatening) adverse event related to treatment. | participants | NUMBER |
| POST_HOC | Time to Progression | After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); ever 3-4 months after treatment up to 2 years | Weeks | MEAN |
Source ClinicalTrials.gov
Results by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Progression-free Survival of Patients Treated With the Study Drug as Defined by RECIST Criteria. | Bevacizumab | 12.4 | 95% Confidence Interval 10.1 to 14.76 | Weeks | |
| Objective Response Rate in Patients Treated With Bevacizumab. | Bevacizumab | Partial response | 4 | Participants | |
| Objective Response Rate in Patients Treated With Bevacizumab. | Bevacizumab | Stable disease | 15 | Participants | |
| Objective Response Rate in Patients Treated With Bevacizumab. | Bevacizumab | Progressive disease | 11 | Participants | |
| Assess the Treatment Effect of Bevacizumab on Duration of Overall Survival | Bevacizumab | 107 | 95% Confidence Interval 44.29 to 169.99 | Weeks | |
| Evaluate the Toxicity of Bevacizumab. | Bevacizumab | Participants with one bevacizumab related event | 26 | participants | |
| Evaluate the Toxicity of Bevacizumab. | Bevacizumab | Thromboyctopenia | 4 | participants | |
| Evaluate the Toxicity of Bevacizumab. | Bevacizumab | Shortness of breath | 5 | participants | |
| Evaluate the Toxicity of Bevacizumab. | Bevacizumab | Hypertension | 7 | participants | |
| Evaluate the Toxicity of Bevacizumab. | Bevacizumab | Pain | 3 | participants |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Registered to Study | STARTED | Bevacizumab | 32 | |
| Registered to Study | COMPLETED | Bevacizumab | 32 | |
| Registered to Study | NOT COMPLETED | Bevacizumab | 0 | |
| Bevacizumab Treatment Cycles 1-2 | STARTED | Bevacizumab | 32 | |
| Bevacizumab Treatment Cycles 1-2 | COMPLETED | Bevacizumab | 30 | |
| Bevacizumab Treatment Cycles 1-2 | NOT COMPLETED | Bevacizumab | 2 | |
| First Response Assessment | STARTED | Bevacizumab | 30 | |
| First Response Assessment | COMPLETED | Bevacizumab | 26 | |
| First Response Assessment | NOT COMPLETED | Bevacizumab | 4 | |
| Continued Bevacizumab Cycle 3+ | STARTED | Bevacizumab | 26 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events83
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Bevacizumab | 17 | 30 | 23 |
| other | Headache | Nervous system disorders | Bevacizumab | 10 | 30 | 18 |
| other | Hemoglobin (anemia) | Blood and lymphatic system disorders | Bevacizumab | 9 | 30 | 16 |
| other | Leukocytes (total white blood cells) | Blood and lymphatic system disorders | Bevacizumab | 5 | 30 | 10 |
| other | Lymphopenia | Blood and lymphatic system disorders | Bevacizumab | 2 | 30 | 2 |
| other | Platelet decrease | Blood and lymphatic system disorders | Bevacizumab | 7 | 30 | 16 |
| other | hypertension | Cardiac disorders | Bevacizumab | 15 | 30 | 24 |
| other | Palpitations | Cardiac disorders | Bevacizumab | 1 | 30 | 1 |
| other | Supraventricular and nodal arrhythmia- atrial fibrillation | Cardiac disorders | Bevacizumab | 2 | 30 | 2 |
| other | Fever | General disorders | Bevacizumab | 4 | 30 | 4 |
1 to 10 of 83Source ClinicalTrials.gov
See all 83 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bevacizumab | 14 | 30 |
| Total, other adverse events | Bevacizumab | 30 | 30 |
| Total, serious adverse events | Bevacizumab | 8 | 30 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00288015
GET https://conductscience.org/api/trials/v1/NCT00288015/results?page=2