Trial Outcomes & Findings for Safety Study Of Avastin And Pelvic Radiation In Women With Recurrent Gynecological Cancers (NCT NCT00545792)
NCT ID: NCT00545792
Last Updated: 2017-03-15
Results Overview
Toxicity was the cumulative number of events, all grades and categories, related to side effects from avastin and radiation including, but not limited to, bowel, bladder, skin, gynecologic and other morbidity.
COMPLETED
PHASE2
21 participants
1-year
2017-03-15
Participant Flow
Recruitment period was between 2008-2010. Patients seen in consultation in a gynecologic oncology or radiation oncology clinic at any of the participating institutions and recommended to undergo radiation for recurrent gynecological cancer were evaluated for eligibility.
Pretreatment evaluations included medical interview, blood pressure check, complete blood count, chemistries, urine analysis and liver function tests. Tumor biopsy was performed at diagnosis. Radiologic imaging (CT, PET-CT, or MR) was performed at diagnosis.
Participant milestones
| Measure |
Avastin
Avastin and daily radiation
Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses.
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Avastin
Avastin and daily radiation
Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Safety Study Of Avastin And Pelvic Radiation In Women With Recurrent Gynecological Cancers
Baseline characteristics by cohort
| Measure |
Avastin
n=21 Participants
Avastin and daily radiation
Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-yearPopulation: 20 patients received and completed treatment.
Toxicity was the cumulative number of events, all grades and categories, related to side effects from avastin and radiation including, but not limited to, bowel, bladder, skin, gynecologic and other morbidity.
Outcome measures
| Measure |
Avastin
n=20 Participants
Avastin and daily radiation
Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses.
|
|---|---|
|
Toxicity Rates of Patients Treated With Concurrent Avastin and Daily Pelvic Radiation With no Other Concurrent Chemotherapy
|
766 Events
|
SECONDARY outcome
Timeframe: 1-yearPopulation: 20 patients received and completed treatment.
Progression free survival was calculated from the date of diagnosis to the date of disease progression as detected by clinical examination or imaging.
Outcome measures
| Measure |
Avastin
n=20 Participants
Avastin and daily radiation
Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses.
|
|---|---|
|
Single Point Estimate of 1-year Progression-free Survival of Patients Treated With Concurrent Avastin and Daily Pelvic Radiation With no Other Concurrent Chemotherapy
|
16 participants
|
Adverse Events
Avastin
Serious adverse events
| Measure |
Avastin
n=20 participants at risk
Avastin and daily radiation
Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses.
|
|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
20.0%
4/20 • Number of events 4 • 1 year
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
10.0%
2/20 • Number of events 2 • 1 year
|
|
Vascular disorders
Portal Vein Flow
|
5.0%
1/20 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Hemorrhage, GI
|
5.0%
1/20 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Avastin
n=20 participants at risk
Avastin and daily radiation
Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
90.0%
18/20 • Number of events 42 • 1 year
|
|
Vascular disorders
Vascular event
|
5.0%
1/20 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Genitourinary/bladder event
|
55.0%
11/20 • Number of events 20 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary event
|
25.0%
5/20 • Number of events 14 • 1 year
|
|
Ear and labyrinth disorders
Tinnitus
|
5.0%
1/20 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Hemoglobin
|
60.0%
12/20 • Number of events 35 • 1 year
|
|
Blood and lymphatic system disorders
Leukocytes
|
95.0%
19/20 • Number of events 66 • 1 year
|
|
Blood and lymphatic system disorders
Lymphopenia
|
85.0%
17/20 • Number of events 63 • 1 year
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes
|
25.0%
5/20 • Number of events 7 • 1 year
|
|
Blood and lymphatic system disorders
Platelets
|
70.0%
14/20 • Number of events 28 • 1 year
|
|
Cardiac disorders
Palpitation
|
5.0%
1/20 • Number of events 1 • 1 year
|
|
Cardiac disorders
Hypertension
|
35.0%
7/20 • Number of events 14 • 1 year
|
|
General disorders
Fatigue
|
90.0%
18/20 • Number of events 57 • 1 year
|
|
General disorders
Weight change
|
20.0%
4/20 • Number of events 9 • 1 year
|
|
Investigations
Coagulation
|
5.0%
1/20 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dermatologic symptoms
|
70.0%
14/20 • Number of events 28 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
50.0%
10/20 • Number of events 18 • 1 year
|
|
Gastrointestinal disorders
Other Gastrointestinal event
|
70.0%
14/20 • Number of events 60 • 1 year
|
|
General disorders
Hemorrhage
|
45.0%
9/20 • Number of events 31 • 1 year
|
|
Infections and infestations
Infection
|
30.0%
6/20 • Number of events 8 • 1 year
|
|
General disorders
Edema
|
25.0%
5/20 • Number of events 11 • 1 year
|
|
Reproductive system and breast disorders
Gynecologic symptoms
|
20.0%
4/20 • Number of events 5 • 1 year
|
|
General disorders
Pain
|
75.0%
15/20 • Number of events 42 • 1 year
|
|
Psychiatric disorders
Mood Alteration
|
25.0%
5/20 • Number of events 7 • 1 year
|
|
Nervous system disorders
Neurological event
|
40.0%
8/20 • Number of events 16 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal event
|
15.0%
3/20 • Number of events 7 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
90.0%
18/20 • Number of events 44 • 1 year
|
|
Metabolism and nutrition disorders
Other metabolic/laboratory
|
95.0%
19/20 • Number of events 125 • 1 year
|
Additional Information
Akila N. Viswanathan, MD, MPH
Dana-Farber Cancer Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place