Trial Outcomes & Findings for Bevacizumab and Irinotecan to Treat Brain Tumors (NCT NCT00393094)
NCT ID: NCT00393094
Last Updated: 2012-07-13
Results Overview
Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline.
TERMINATED
PHASE2
31 participants
23 months (date of first enrollment to 1 month after last progression)
2012-07-13
Participant Flow
Participant milestones
| Measure |
Enrollment Until Prior to Treatment
|
|---|---|
|
Period1Bevacizumab & Irinotecan Patients
STARTED
|
31
|
|
Period1Bevacizumab & Irinotecan Patients
COMPLETED
|
30
|
|
Period1Bevacizumab & Irinotecan Patients
NOT COMPLETED
|
1
|
|
Disease Progression After Trtmt: Onstudy
STARTED
|
30
|
|
Disease Progression After Trtmt: Onstudy
COMPLETED
|
29
|
|
Disease Progression After Trtmt: Onstudy
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Enrollment Until Prior to Treatment
|
|---|---|
|
Period1Bevacizumab & Irinotecan Patients
Disease progression before treatment
|
1
|
|
Disease Progression After Trtmt: Onstudy
Refused further treatment
|
1
|
Baseline Characteristics
Bevacizumab and Irinotecan to Treat Brain Tumors
Baseline characteristics by cohort
| Measure |
Enrollment Until Prior to Treatment
n=31 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age Continuous
|
46.96 years
STANDARD_DEVIATION 10.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 23 months (date of first enrollment to 1 month after last progression)Population: Analysis is per protocol (N=30), excluding the 1 patient who progressed and withdrew consent prior to any treatment but after enrollment.
Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline.
Outcome measures
| Measure |
Enrollment Until Prior to Treatment
n=30 Participants
|
|---|---|
|
Radiographic Response Rate (Malignant Glioma Participants)
Partial response
|
0 Percent of participants
|
|
Radiographic Response Rate (Malignant Glioma Participants)
Complete response
|
0 Percent of participants
|
|
Radiographic Response Rate (Malignant Glioma Participants)
Stable disease
|
16.7 Percent of participants
|
|
Radiographic Response Rate (Malignant Glioma Participants)
Progressive disease
|
83.3 Percent of participants
|
PRIMARY outcome
Timeframe: 23 months (date of first enrollment to 1 month after last progression)Population: Analysis is per protocol (N=30), excluding the 1 patient who progressed and withdrew consent prior to any treatment but after enrollment.
Here is the number of participants with any toxicity, defined as any adverse events possibly, probably or definitely related to the investigational drugs. For the detailed list of investigational new drug (IND)-related toxicities and other serious adverse events, see the adverse event module.
Outcome measures
| Measure |
Enrollment Until Prior to Treatment
n=30 Participants
|
|---|---|
|
Number of Participants With Toxicity as Measured by The National Cancer Institute (NCI) Common Toxicity Criteria v. 3.0.
|
27 Participants
|
PRIMARY outcome
Timeframe: 23 months (date of first enrollment to 1 month after last progression)Population: Analysis is per protocol (N=30), excluding the 1 patient who progressed and withdrew consent prior to any treatment but after enrollment.
Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline.
Outcome measures
| Measure |
Enrollment Until Prior to Treatment
n=30 Participants
|
|---|---|
|
Radiographic Response Rate (Anaplastic Glioma Participants)
Partial response
|
0 Percent of participants
|
|
Radiographic Response Rate (Anaplastic Glioma Participants)
Complete response
|
0 Percent of participants
|
|
Radiographic Response Rate (Anaplastic Glioma Participants)
Stable disease
|
30 Percent of participants
|
|
Radiographic Response Rate (Anaplastic Glioma Participants)
Progressive disease
|
70 Percent of participants
|
PRIMARY outcome
Timeframe: 23 months (date of first enrollment to 1 month after last progression)Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline.
Outcome measures
| Measure |
Enrollment Until Prior to Treatment
n=20 Participants
|
|---|---|
|
Radiographic Response Rate (Glioblastoma Multiforme Participants)
Partial response
|
0 Percent of participants
|
|
Radiographic Response Rate (Glioblastoma Multiforme Participants)
Complete response
|
0 Percent of participants
|
|
Radiographic Response Rate (Glioblastoma Multiforme Participants)
Stable disease
|
10 Percent of participants
|
|
Radiographic Response Rate (Glioblastoma Multiforme Participants)
Progressive disease
|
90 Percent of participants
|
Adverse Events
Enrollment Until Prior to Treatment
Serious adverse events
| Measure |
Enrollment Until Prior to Treatment
n=30 participants at risk
|
|---|---|
|
General disorders
Death not associated with CTCAE term: Death Progression NOS
|
3.3%
1/30 • Number of events 1 • 23 months
|
|
Investigations
Hemoglobin
|
6.7%
2/30 • Number of events 2 • 23 months
|
|
Nervous system disorders
Neurology: Seizure
|
16.7%
5/30 • Number of events 5 • 23 months
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
3.3%
1/30 • Number of events 1 • 23 months
|
|
Blood and lymphatic system disorders
Leukocytes (total white blood count (WBC))
|
3.3%
1/30 • Number of events 2 • 23 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.3%
1/30 • Number of events 2 • 23 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (absolute neutrophil count (ANC)/absolute granulocyte count (AGC))
|
3.3%
1/30 • Number of events 3 • 23 months
|
|
Vascular disorders
Hypotension
|
3.3%
1/30 • Number of events 1 • 23 months
|
|
Blood and lymphatic system disorders
DIC (disseminated intravascular coagulation)
|
3.3%
1/30 • Number of events 1 • 23 months
|
|
Metabolism and nutrition disorders
Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT)
|
3.3%
1/30 • Number of events 1 • 23 months
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT)
|
3.3%
1/30 • Number of events 1 • 23 months
|
|
Renal and urinary disorders
Renal Failure
|
3.3%
1/30 • Number of events 1 • 23 months
|
Other adverse events
| Measure |
Enrollment Until Prior to Treatment
n=30 participants at risk
|
|---|---|
|
Investigations
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
16.7%
5/30 • Number of events 6 • 23 months
|
|
Investigations
Alkaline phosphatase
|
6.7%
2/30 • Number of events 2 • 23 months
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
6.7%
2/30 • Number of events 3 • 23 months
|
|
Gastrointestinal disorders
Diarrhea
|
30.0%
9/30 • Number of events 10 • 23 months
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
60.0%
18/30 • Number of events 22 • 23 months
|
|
Investigations
Hemoglobin
|
10.0%
3/30 • Number of events 3 • 23 months
|
|
Vascular disorders
Hypertension
|
3.3%
1/30 • Number of events 1 • 23 months
|
|
Investigations
Leukocytes (total WBC)
|
30.0%
9/30 • Number of events 12 • 23 months
|
|
Investigations
Lymphopenia
|
3.3%
1/30 • Number of events 3 • 23 months
|
|
Gastrointestinal disorders
Nausea
|
33.3%
10/30 • Number of events 13 • 23 months
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
16.7%
5/30 • Number of events 13 • 23 months
|
|
Nervous system disorders
Pain: head/headache
|
10.0%
3/30 • Number of events 3 • 23 months
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
23.3%
7/30 • Number of events 12 • 23 months
|
|
Investigations
Platelets
|
16.7%
5/30 • Number of events 9 • 23 months
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
5/30 • Number of events 5 • 23 months
|
|
General disorders
Cytokine release syndrome/acute infusion reaction
|
6.7%
2/30 • Number of events 2 • 23 months
|
|
Metabolism and nutrition disorders
Anorexia
|
3.3%
1/30 • Number of events 2 • 23 months
|
|
Blood and lymphatic system disorders
Hemorrhage, central nervous system (CNS)
|
3.3%
1/30 • Number of events 1 • 23 months
|
|
Blood and lymphatic system disorders
Hemorrhage, genitourinary (GU) retroperitoneum
|
3.3%
1/30 • Number of events 1 • 23 months
|
|
Blood and lymphatic system disorders
Hemorrhage, pulmonary/upper respiratory: Nose
|
10.0%
3/30 • Number of events 3 • 23 months
|
|
Renal and urinary disorders
Proteinuria
|
10.0%
3/30 • Number of events 3 • 23 months
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
3.3%
1/30 • Number of events 1 • 23 months
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
3.3%
1/30 • Number of events 1 • 23 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
3.3%
1/30 • Number of events 1 • 23 months
|
Additional Information
Howard A. Fine, M.D.
National Cancer Institute, National Institutes of Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place