Trial Outcomes & Findings for Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer (NCT NCT00130520)
NCT ID: NCT00130520
Last Updated: 2012-05-28
Results Overview
Objective response was defined using standard RECIST criteria. CR(complete response)= disappearance of all target lesions PR(partial response)=30% decrease in the sum of the longest diameter of target lesions PD(progressive disease)=20% increase in the sum of the longest diameter of target lesions SD(stable disease)= small changes that do not meet above criteria
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
06.16.2005 to 10.05.2009
Results posted on
2012-05-28
Participant Flow
The study began recruiting in June of 2005 and ended recruitment in January of 2008. All subjects were seen and treated at the Arizona Cancer Center in Tucson, Arizona.
The study had no pre-assignment criteria. This was an open label study and all subjects were given the same treatment.
Participant milestones
| Measure |
Bevacizumab and Erlotinib
This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
Completion of at Least One Cycle
|
39
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
39
|
Reasons for withdrawal
| Measure |
Bevacizumab and Erlotinib
This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
|
|---|---|
|
Overall Study
Adverse Event
|
11
|
|
Overall Study
Death
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Disease Progression
|
23
|
|
Overall Study
Protocol non-compliance
|
1
|
|
Overall Study
Did not meet re-treatment criteria
|
1
|
Baseline Characteristics
Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Bevacizumab and Erlotinib
n=40 Participants
This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
|
|---|---|
|
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
|
10 Participants
n=5 Participants
|
|
Age Continuous
|
59.35 years
STANDARD_DEVIATION 11.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 06.16.2005 to 10.05.2009Population: Population=subjects receiving 1 dose of intervention and one assessment post-baseline. One subject=not evaluable. Analysis-Enroll 40, initial accrual of 20. If ≤1 confirmed responses observed in 20=closure. If ≥2 responses=20 additional.
Objective response was defined using standard RECIST criteria. CR(complete response)= disappearance of all target lesions PR(partial response)=30% decrease in the sum of the longest diameter of target lesions PD(progressive disease)=20% increase in the sum of the longest diameter of target lesions SD(stable disease)= small changes that do not meet above criteria
Outcome measures
| Measure |
Bevacizumab and Erlotinib
n=39 Participants
This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
|
|---|---|
|
Objective Response (Complete Partial, Stable and Progression)
Complete Response
|
1 Participants
|
|
Objective Response (Complete Partial, Stable and Progression)
Partial Response
|
8 Participants
|
|
Objective Response (Complete Partial, Stable and Progression)
Stable Disease
|
10 Participants
|
|
Objective Response (Complete Partial, Stable and Progression)
Disease Progression
|
20 Participants
|
PRIMARY outcome
Timeframe: 1 week to 96 weeksPopulation: Population=subjects receiving 1 dose of intervention and one assessment post-baseline. One subject=not evaluable. Analysis-Enroll 40, initial accrual of 20. If ≤1 confirmed responses observed in 20=closure. If ≥2 responses=20 additional.
Response duration=time (in weeks) between date of measurable response and date of progression (progression=20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in opinion of treating physician, any new lesion/site, death due to disease)if known or the date the subject went off protocol if they were still considered responders (ie do not qualify as progression) or are stable (Does not qualify for CR, PR, progression or Symptomatic Deterioration)
Outcome measures
| Measure |
Bevacizumab and Erlotinib
n=39 Participants
This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
|
|---|---|
|
Median Response Duration (Weeks)
Responders
|
36.1 weeks
Interval 5.6 to 83.0
|
|
Median Response Duration (Weeks)
Stable
|
25.6 weeks
Interval 6.0 to
|
SECONDARY outcome
Timeframe: June 2005 to October 5, 2009Population: The population analyzed included all participants receiving at least 1 dose of study intervention and at least one assessment post-baseline. One subject was not evaluable. Analysis was per protocol
PFS was defined as the time from the start of therapy to the time of the first documentation of progression(progression=20% increase in sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in the opinion of treating physician, appearance of new lesion/site, Death due to disease), symptomatic deterioration (global deterioration of health status requiring discontinuation of treatment without objective evidence of progression), or death due to any cause;
Outcome measures
| Measure |
Bevacizumab and Erlotinib
n=39 Participants
This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
|
|---|---|
|
Progression Free Survival(PFS)
|
4 months
Interval 1.0 to 26.8
|
Adverse Events
Bevacizumab and Erlotinib
Serious events: 12 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab and Erlotinib
n=40 participants at risk
This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
|
|---|---|
|
General disorders
Hospitalization for dyspnea and fatigue
|
2.5%
1/40 • Number of events 16 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
General disorders
hospitalization for diarrhea, nausea, vomiting and facial rash (CTCAE grade 2)
|
2.5%
1/40 • Number of events 16 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Gastrointestinal disorders
Hospitalization for partial bowel obstruction
|
2.5%
1/40 • Number of events 16 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
General disorders
Hospitalizaton for diarrhea, abdomianl bloating, dyspnea
|
2.5%
1/40 • Number of events 16 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
General disorders
Death
|
2.5%
1/40 • Number of events 16 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Cardiac disorders
Myocardial infarct
|
2.5%
1/40 • Number of events 16 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Gastrointestinal disorders
Bowel perforation-large intestine
|
2.5%
1/40 • Number of events 16 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Cardiac disorders
Possible Myocardial infarction
|
2.5%
1/40 • Number of events 16 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Cardiac disorders
Abdominal fistula
|
2.5%
1/40 • Number of events 16 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
General disorders
Nasal septal perforation
|
2.5%
1/40 • Number of events 16 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
General disorders
Hospitalization for intercranial bleed
|
2.5%
1/40 • Number of events 16 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
General disorders
Hospitalization for fever
|
2.5%
1/40 • Number of events 16 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
General disorders
Hospitilization for skin rash and pain
|
2.5%
1/40 • Number of events 16 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
General disorders
Hospitilization for weakness and low hemoglobin
|
2.5%
1/40 • Number of events 16 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
General disorders
Hospitalization for fatigue, dyspnea, weakness
|
2.5%
1/40 • Number of events 16 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
General disorders
Hospitalization for headache and parasthesis
|
2.5%
1/40 • Number of events 16 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
Other adverse events
| Measure |
Bevacizumab and Erlotinib
n=40 participants at risk
This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
|
|---|---|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
17.5%
7/40 • Number of events 7 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Immune system disorders
Allergy/Immunology-Other
|
7.5%
3/40 • Number of events 3 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
12.5%
5/40 • Number of events 5 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Blood and lymphatic system disorders
Neutrophils/granuloctyes (ANC/AGC)
|
10.0%
4/40 • Number of events 4 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Blood and lymphatic system disorders
Platelets
|
5.0%
2/40 • Number of events 2 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
5.0%
2/40 • Number of events 2 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Cardiac disorders
Hypertension
|
25.0%
10/40 • Number of events 10 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
General disorders
Constitutional Symptoms (Other)
|
5.0%
2/40 • Number of events 2 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
General disorders
Fatigue
|
40.0%
16/40 • Number of events 16 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
General disorders
Insomnia
|
12.5%
5/40 • Number of events 5 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
General disorders
Rigors/chills
|
7.5%
3/40 • Number of events 3 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
General disorders
Weight loss
|
25.0%
10/40 • Number of events 10 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
32.5%
13/40 • Number of events 13 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
General disorders
Fever (in the absence of neutropenia)
|
7.5%
3/40 • Number of events 3 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
10.0%
4/40 • Number of events 4 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
7.5%
3/40 • Number of events 3 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritius/itching
|
15.0%
6/40 • Number of events 6 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
22.5%
9/40 • Number of events 9 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
77.5%
31/40 • Number of events 31 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
5.0%
2/40 • Number of events 2 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
7.5%
3/40 • Number of events 3 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Gastrointestinal disorders
Anorexia
|
37.5%
15/40 • Number of events 15 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
45.0%
18/40 • Number of events 18 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
4/40 • Number of events 4 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Gastrointestinal disorders
Dehydration
|
7.5%
3/40 • Number of events 3 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
82.5%
33/40 • Number of events 33 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
20.0%
8/40 • Number of events 8 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
5.0%
2/40 • Number of events 2 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swllowing)
|
5.0%
2/40 • Number of events 2 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Gastrointestinal disorders
Flatulence
|
12.5%
5/40 • Number of events 5 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal-Other
|
30.0%
12/40 • Number of events 12 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
17.5%
7/40 • Number of events 7 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.0%
2/40 • Number of events 2 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clincal exam)
|
5.0%
2/40 • Number of events 2 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
15.0%
6/40 • Number of events 6 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
16/40 • Number of events 16 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Gastrointestinal disorders
Taste alteration dysgeusia)
|
27.5%
11/40 • Number of events 11 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
35.0%
14/40 • Number of events 14 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Gastrointestinal disorders
Hemorrhage, GI
|
17.5%
7/40 • Number of events 7 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory
|
12.5%
5/40 • Number of events 5 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding-Other
|
7.5%
3/40 • Number of events 3 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Infections and infestations
Infection
|
27.5%
11/40 • Number of events 11 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Infections and infestations
Infection (documented clinically or microbiologically)
|
12.5%
5/40 • Number of events 5 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
12.5%
5/40 • Number of events 5 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Infections and infestations
Infection with unknown ANC
|
17.5%
7/40 • Number of events 7 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Blood and lymphatic system disorders
Edema:limb
|
7.5%
3/40 • Number of events 3 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Blood and lymphatic system disorders
Lymphatics-Other
|
5.0%
2/40 • Number of events 2 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
67.5%
27/40 • Number of events 27 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
12.5%
5/40 • Number of events 5 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
15.0%
6/40 • Number of events 6 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Metabolism and nutrition disorders
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
15.0%
6/40 • Number of events 6 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
10.0%
4/40 • Number of events 4 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
5.0%
2/40 • Number of events 2 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Metabolism and nutrition disorders
Creatinine
|
17.5%
7/40 • Number of events 7 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
5.0%
2/40 • Number of events 2 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
5.0%
2/40 • Number of events 2 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Metabolism and nutrition disorders
Proteinuria
|
12.5%
5/40 • Number of events 5 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
22.5%
9/40 • Number of events 9 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
25.0%
10/40 • Number of events 10 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
15.0%
6/40 • Number of events 6 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue-Other
|
20.0%
8/40 • Number of events 8 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Nervous system disorders
Ataxia (incoordination)
|
5.0%
2/40 • Number of events 2 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Nervous system disorders
Dizziness
|
17.5%
7/40 • Number of events 7 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Psychiatric disorders
Mood Alteration
|
12.5%
5/40 • Number of events 5 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Nervous system disorders
Neuropathy: cranial or sensory
|
10.0%
4/40 • Number of events 4 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Nervous system disorders
Tremor
|
5.0%
2/40 • Number of events 2 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Eye disorders
Dry Eye Syndrome
|
12.5%
5/40 • Number of events 5 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Eye disorders
Ocular/Visual-Other
|
10.0%
4/40 • Number of events 4 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Eye disorders
Blurred Vision
|
10.0%
4/40 • Number of events 4 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
General disorders
Pain
|
52.5%
21/40 • Number of events 21 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
8/40 • Number of events 8 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
7.5%
3/40 • Number of events 3 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
25.0%
10/40 • Number of events 10 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
20.0%
8/40 • Number of events 8 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Renal and urinary disorders
Renal/Genitourinary-other
|
15.0%
6/40 • Number of events 6 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Renal and urinary disorders
Urinary Frequency/Urgency
|
5.0%
2/40 • Number of events 2 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Reproductive system and breast disorders
Vaginal mucositis
|
5.0%
2/40 • Number of events 2 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Vascular disorders
Vascular-Other
|
7.5%
3/40 • Number of events 3 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
General disorders
Pain-Other
|
22.5%
9/40 • Number of events 9 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other
|
20.0%
8/40 • Number of events 8 • Collected from the start of the 1st subject 6/2005 until the last subject was off treatment which was October 5, 2009 as the data was truncated for the purpose of the publication. Subjects came in for treatment every 2 weeks.
|
Additional Information
Setsuko K. Chambers, M.D.
Arizona Cancer Center, University of Arizona
Phone: 520-626-0950
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place