Trial · NCT00953121

Bevacizumab Plus Irinotecan Plus Carboplatin for Recurrent Malignant Glioma (MG)

NCT00953121, Phase 2, Completed, Annick Desjardins; results first posted 2013-09-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Bevacizumab Plus Irinotecan Plus Carboplatin for Recurrent Malignant Glioma (MG). Trials, record NCT00953121. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00953121

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Bevacizumab Plus Irinotecan Plus Carboplatin for Recurrent Malignant Glioma (MG)
NCT number: NCT00953121
Status: Completed
Phases: Phase 2
Enrollment: 104 participants, actual
Lead sponsor: Annick Desjardins
Conditions: Malignant Glioma
Interventions: bevacizumab and CPT-11 and Carboplatin
First posted: 2009-08-06
Last updated: 2013-09-16
Results first posted: 2013-09-04

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	6 Month Progression-free Survival	6 months	Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Response Assessment in Neuro-Oncology (RANO) criteria, or to death due to any cause. Progression is defined as greater than or equal to a 25% increase in the product of the largest perpendicular diameters of any enhancing lesion or any new enhancing tumor on MRI scans. Patients may also be classified as progressive disease with significant neurologic decline felt to be due to underlying tumor and not attributable to co-morbid event or concurrent medication regardless of MRI findings.
Secondary	Objective Response Rate	34 months	Percentage of participants with an objective response (complete response or partial response) based on Response Assessment in Neuro-Oncology (RANO) criteria. A complete response is defined as disappearance of all enhancing tumor on contrast enhanced MRI scan. Patient must be off steroids or only on adrenal maintenance doses. A partial response is defined as greater than or equal to a 50% reduction in the size (products of the largest perpendicular diameters) for all enhancing lesions. No new lesions may arise. Steroids must be stable or decreasing dose.
Secondary	Median Progression Free Survival (PFS)	40 months	Time in months from the start of study treatment to the date of first progression according to RANO criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.
Secondary	Median Overall Survival (OS)	40 months	Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.
Secondary	Safety of Bevacizumab (Avastin) in Combination With Irinotecan and Carboplatin	34 months	Number of patients experiencing a toxicity greater than or equal to grade 2 treatment-related toxicity

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	6 Month Progression-free Survival	6 months		percentage of participants	NUMBER
SECONDARY	Objective Response Rate	34 months	The number of participants analyzed is lower than the total number in the study for each arm due to the fact that some patients progressed or experienced an adverse event which resulted in being taken off study during the first cycle and thus were never evaluated for radiographic response.	participants	NUMBER
SECONDARY	Median Progression Free Survival (PFS)	40 months		months	MEDIAN
SECONDARY	Median Overall Survival (OS)	40 months		months	MEDIAN
SECONDARY	Safety of Bevacizumab (Avastin) in Combination With Irinotecan and Carboplatin	34 months		participants	NUMBER

Source ClinicalTrials.gov

Results by group15

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
6 Month Progression-free Survival	Grade IV, No Bevacizumab Failure	47.5	95% Confidence Interval 31.6 to 61.8	percentage of participants
6 Month Progression-free Survival	Grade III, No Bevacizumab Failure	71.1	95% Confidence Interval 53.9 to 82.8	percentage of participants
6 Month Progression-free Survival	Grade IV, Bevacizumab Failure	24.0	95% Confidence Interval 9.8 to 41.7	percentage of participants
Objective Response Rate	Grade IV, No Bevacizumab Failure	0		participants
Objective Response Rate	Grade III, No Bevacizumab Failure	0		participants
Objective Response Rate	Grade IV, Bevacizumab Failure	0		participants
Median Progression Free Survival (PFS)	Grade IV, No Bevacizumab Failure	5.9	95% Confidence Interval 4.8 to 8.5	months
Median Progression Free Survival (PFS)	Grade III, No Bevacizumab Failure	10.0	95% Confidence Interval 7.3 to 12.1	months
Median Progression Free Survival (PFS)	Grade IV, Bevacizumab Failure	3.6	95% Confidence Interval 2.7 to 4.3	months
Median Overall Survival (OS)	Grade IV, No Bevacizumab Failure	9.3	95% Confidence Interval 7.0 to 11.9	months

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Grade IV, No Bevacizumab Failure	40
Overall Study	STARTED	Grade III, No Bevacizumab Failure	39
Overall Study	STARTED	Grade IV, Bevacizumab Failure	25
Overall Study	COMPLETED	Grade IV, No Bevacizumab Failure	40
Overall Study	COMPLETED	Grade III, No Bevacizumab Failure	39
Overall Study	COMPLETED	Grade IV, Bevacizumab Failure	25
Overall Study	NOT COMPLETED	Grade IV, No Bevacizumab Failure	0
Overall Study	NOT COMPLETED	Grade III, No Bevacizumab Failure	0
Overall Study	NOT COMPLETED	Grade IV, Bevacizumab Failure	0

Source ClinicalTrials.gov

Adverse events402

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
other	Anemia	Blood and lymphatic system disorders	Grade IV, No Bevacizumab Failure	8	40
other	Anemia	Blood and lymphatic system disorders	Grade III, No Bevacizumab Failure	7	39
other	Anemia	Blood and lymphatic system disorders	Grade IV, Bevacizumab Failure	4	25
other	Palpitations	Cardiac disorders	Grade IV, No Bevacizumab Failure	0	40
other	Palpitations	Cardiac disorders	Grade III, No Bevacizumab Failure	1	39
other	Palpitations	Cardiac disorders	Grade IV, Bevacizumab Failure	0	25
other	Hearing impaired	Ear and labyrinth disorders	Grade IV, No Bevacizumab Failure	1	40
other	Hearing impaired	Ear and labyrinth disorders	Grade III, No Bevacizumab Failure	0	39
other	Hearing impaired	Ear and labyrinth disorders	Grade IV, Bevacizumab Failure	0	25
other	Optic nerve disorder	Eye disorders	Grade IV, No Bevacizumab Failure	0	40

1 to 10 of 402Source ClinicalTrials.gov

See all 402 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Grade IV, No Bevacizumab Failure
Total, all-cause mortality	Grade III, No Bevacizumab Failure
Total, all-cause mortality	Grade IV, Bevacizumab Failure
Total, other adverse events	Grade IV, No Bevacizumab Failure	34	40
Total, other adverse events	Grade III, No Bevacizumab Failure	37	39
Total, other adverse events	Grade IV, Bevacizumab Failure	21	25
Total, serious adverse events	Grade IV, No Bevacizumab Failure	17	40
Total, serious adverse events	Grade III, No Bevacizumab Failure	10	39
Total, serious adverse events	Grade IV, Bevacizumab Failure	6	25

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21986722	DERIVED

Source PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00953121

GET https://conductscience.org/api/trials/v1/NCT00953121/events?page=2

API reference For AI assistants