Trial · NCT00923936
Pilot Study of Liposomal Doxorubicin Combined With Bevacizumab Followed by Bevacizumab Monotherapy in Adults With Advanced Kaposi s Sarcoma
NCT00923936, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-06-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pilot Study of Liposomal Doxorubicin Combined With Bevacizumab Followed by Bevacizumab Monotherapy in Adults With Advanced Kaposi s Sarcoma. Trials, record NCT00923936. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00923936
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Study of Liposomal Doxorubicin Combined With Bevacizumab Followed by Bevacizumab Monotherapy in Adults With Advanced Kaposi s Sarcoma
- NCT number
- NCT00923936
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Sarcoma, Kaposi
- Interventions
- Liposomal Doxorubicin, Bevacizumab
- First posted
- 2009-06-18
- Last updated
- 2018-07-24
- Results first posted
- 2017-06-16
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) of Six Cycles of Liposomal Doxorubicin Combined With Bevacizumab in Patients With Advanced KS. | 6 cycles, an average of 18 weeks | Overall response rate is complete response + clinical complete response + partial response. The overall response rate is the fraction of subjects with an overall response after 6 cycles of liposomal doxorubicin in combination with bevacizumab. Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Complete response is the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks. Clinical complete response is the absence of any detectable residual disease, including tumor associated edema. persisting for at least 4 weeks. Partial response is no progressive disease (increase of 25% or more over baseline in the number of lesions and/or size (sum of the products of the largest perpendicular diameters of the marker lesions) \& noting that single lesions which split up into 2 or more smaller lesions during the course of treatment will still be counted as 1. |
| Secondary | Complete Response Rate After 6 Cycles of Liposomal Doxorubicin Combined With Bevacizumab | 6 cycles, an average of 18 weeks | Complete response rate is the fraction of subjects with an complete response after 6 cycles of liposomal doxorubicin in combination with bevacizumab. Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Complete response is the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks. In patients whom pigmented macular skin lesions persist after apparent complete response, biopsy of at least one representative lesion is required to document the absence of malignant cells. In patients known to have had visceral disease, an attempt at restaging with appropriate endoscopic or radiographic procedures should be made. If such procedures are medically contraindicated, the patient may be classified as having a clinical complete response. |
| Secondary | Count of Participants With Serious and Non-serious Adverse Events | 7 years and 6 months and 21 days | Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Secondary | Median Number of Cycles Need to Obtain a Partial Response | 6 cycles, an average of 18 weeks | Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Partial response is no progressive disease (increase of 25% or more over baseline in the number of lesions and/or size (sum of the products of the largest perpendicular diameters of the marker lesions) and noting that single lesions which split up into 2 or more smaller lesions during the course of treatment will still be counted as 1; no new lesions occurring in previously uninvolved areas of the body; no new visceral sites of involvement or the appearance or worsening of tumor-associated edema or effusions and a 50% or greater decrease in the number and/or size of previously existing lesions lasting for at least 4 weeks or complete flattening of at least 50% of all previously raised lesions (i.e., 50% of all previously nodular or plaque-like lesions become macular) lasting for at least 4 weeks. |
| Secondary | Percentage of Participants With 12- Month Progression-free Survival (PFS) | 12 months | Participants who survived and were progression free for 12 months. Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Progressive disease is an increase of 25% or more over baseline in the number of lesions and/or size (sum of the products of the largest perpendicular diameters) of the marker lesions or a change in character from macular to plaque-like or nodular of at least 25% of the lesions or new visceral sites of involvement or progression of visceral disease or the development of new or increasing tumor-associated edema or effusion that lasts at least 1 week and interfered with the patient's normal activities. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) of Six Cycles of Liposomal Doxorubicin Combined With Bevacizumab in Patients With Advanced KS. | 6 cycles, an average of 18 weeks | percentage of participants | NUMBER | |
| SECONDARY | Complete Response Rate After 6 Cycles of Liposomal Doxorubicin Combined With Bevacizumab | 6 cycles, an average of 18 weeks | No patients had a complete response. | percentage of participants | NUMBER |
| SECONDARY | Count of Participants With Serious and Non-serious Adverse Events | 7 years and 6 months and 21 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Median Number of Cycles Need to Obtain a Partial Response | 6 cycles, an average of 18 weeks | Cycles | MEDIAN | |
| SECONDARY | Percentage of Participants With 12- Month Progression-free Survival (PFS) | 12 months | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) of Six Cycles of Liposomal Doxorubicin Combined With Bevacizumab in Patients With Advanced KS. | KS; Classic or HIV+ Not Improved on Antivirals | 50 | 80% Confidence Interval 27 to 73 | percentage of participants | |
| Overall Response Rate (ORR) of Six Cycles of Liposomal Doxorubicin Combined With Bevacizumab in Patients With Advanced KS. | All Other Advanced HIV-associated Kaposi's Sarcoma (KS) | 67 | 80% Confidence Interval 33 to 91 | percentage of participants | |
| Complete Response Rate After 6 Cycles of Liposomal Doxorubicin Combined With Bevacizumab | KS; Classic or HIV+ Not Improved on Antivirals | 0 | 80% Confidence Interval 0 to 21 | percentage of participants | |
| Complete Response Rate After 6 Cycles of Liposomal Doxorubicin Combined With Bevacizumab | All Other Advanced HIV-associated Kaposi's Sarcoma (KS) | 0 | 80% Confidence Interval 0 to 32 | percentage of participants | |
| Count of Participants With Serious and Non-serious Adverse Events | KS; Classic or HIV+ Not Improved on Antivirals | 10 | Participants | ||
| Count of Participants With Serious and Non-serious Adverse Events | All Other Advanced HIV-associated Kaposi's Sarcoma (KS) | 6 | Participants | ||
| Median Number of Cycles Need to Obtain a Partial Response | KS; Classic or HIV+ Not Improved on Antivirals | 2 | 95% Confidence Interval 1 to 6 | Cycles | |
| Median Number of Cycles Need to Obtain a Partial Response | All Other Advanced HIV-associated Kaposi's Sarcoma (KS) | 4 | 95% Confidence Interval 1 to 5 | Cycles | |
| Percentage of Participants With 12- Month Progression-free Survival (PFS) | KS; Classic or HIV+ Not Improved on Antivirals | 44 | 95% Confidence Interval 23 to 64 | percentage of participants | |
| Percentage of Participants With 12- Month Progression-free Survival (PFS) | All Other Advanced HIV-associated Kaposi's Sarcoma (KS) | 42 | 95% Confidence Interval 15 to 67 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | KS; Classic or HIV+ Not Improved on Antivirals | 10 | |
| Overall Study | STARTED | All Other Advanced HIV-associated Kaposi's Sarcoma (KS) | 6 | |
| Overall Study | COMPLETED | KS; Classic or HIV+ Not Improved on Antivirals | 2 | |
| Overall Study | COMPLETED | All Other Advanced HIV-associated Kaposi's Sarcoma (KS) | 3 | |
| Overall Study | NOT COMPLETED | KS; Classic or HIV+ Not Improved on Antivirals | 8 | |
| Overall Study | NOT COMPLETED | All Other Advanced HIV-associated Kaposi's Sarcoma (KS) | 3 |
Source ClinicalTrials.gov
Adverse events286
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 | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | KS; Classic or HIV+ Not Improved on Antivirals | 7 | 10 | 26 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | All Other Advanced HIV-associated Kaposi's Sarcoma (KS) | 5 | 6 | 17 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | KS; Classic or HIV+ Not Improved on Antivirals | 8 | 10 | 28 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | All Other Advanced HIV-associated Kaposi's Sarcoma (KS) | 5 | 6 | 16 |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | KS; Classic or HIV+ Not Improved on Antivirals | 4 | 10 | 12 |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | All Other Advanced HIV-associated Kaposi's Sarcoma (KS) | 5 | 6 | 38 |
| other | Alkaline phosphatase | Metabolism and nutrition disorders | KS; Classic or HIV+ Not Improved on Antivirals | 2 | 10 | 4 |
| other | Alkaline phosphatase | Metabolism and nutrition disorders | All Other Advanced HIV-associated Kaposi's Sarcoma (KS) | 3 | 6 | 26 |
| other | Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | KS; Classic or HIV+ Not Improved on Antivirals | 1 | 10 | 1 |
| other | Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | All Other Advanced HIV-associated Kaposi's Sarcoma (KS) | 1 | 6 | 1 |
1 to 10 of 286Source ClinicalTrials.gov
See all 286 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | KS; Classic or HIV+ Not Improved on Antivirals | 0 | 10 |
| Total, all-cause mortality | All Other Advanced HIV-associated Kaposi's Sarcoma (KS) | 0 | 6 |
| Total, other adverse events | KS; Classic or HIV+ Not Improved on Antivirals | 10 | 10 |
| Total, other adverse events | All Other Advanced HIV-associated Kaposi's Sarcoma (KS) | 6 | 6 |
| Total, serious adverse events | KS; Classic or HIV+ Not Improved on Antivirals | 0 | 10 |
| Total, serious adverse events | All Other Advanced HIV-associated Kaposi's Sarcoma (KS) | 1 | 6 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| KS; Classic or HIV+ Not Improved on Antivirals vs All Other Advanced HIV-associated Kaposi's Sarcoma (KS): Count of Participants With Serious and Non-serious Adverse Events | Trial comparisons |
| KS; Classic or HIV+ Not Improved on Antivirals vs All Other Advanced HIV-associated Kaposi's Sarcoma (KS): deaths from any cause | Trial comparisons |
| KS; Classic or HIV+ Not Improved on Antivirals vs All Other Advanced HIV-associated Kaposi's Sarcoma (KS): serious adverse events | Trial comparisons |
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/NCT00923936
GET https://conductscience.org/api/trials/v1/NCT00923936/events?page=2