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Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00130520
Recruitment Status : Completed
First Posted : August 15, 2005
Results First Posted : December 14, 2010
Last Update Posted : May 28, 2012
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of Arizona

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ovarian Neoplasms
Interventions Drug: bevacizumab
Drug: erlotinib
Enrollment 40
Recruitment Details 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.
Pre-assignment Details The study had no pre-assignment criteria. This was an open label study and all subjects were given the same treatment.
Arm/Group Title Bevacizumab and Erlotinib
Hide Arm/Group Description 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
Period Title: Overall Study
Started 40 [1]
Completion of at Least One Cycle 39
Completed 1
Not Completed 39
Reason Not Completed
Adverse Event             11
Death             1
Physician Decision             1
Withdrawal by Subject             1
Disease Progression             23
Protocol non-compliance             1
Did not meet re-treatment criteria             1
[1]
85 women were screened for eligibility, 56 consented, 40 treated.
Arm/Group Title Bevacizumab and Erlotinib
Hide Arm/Group Description 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 Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
  75.0%
>=65 years
10
  25.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
59.35  (11.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
40
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants
40
1.Primary Outcome
Title Objective Response (Complete Partial, Stable and Progression)
Hide Description 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
Time Frame 06.16.2005 to 10.05.2009
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Bevacizumab and Erlotinib
Hide Arm/Group Description:
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 Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: Participants
Complete Response 1
Partial Response 8
Stable Disease 10
Disease Progression 20
2.Primary Outcome
Title Median Response Duration (Weeks)
Hide Description 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)
Time Frame 1 week to 96 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Bevacizumab and Erlotinib
Hide Arm/Group Description:
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 Number of Participants Analyzed 39
Median (Full Range)
Unit of Measure: weeks
Responders
36.1
(5.6 to 83.0)
Stable
25.6
(6.0 to 65.)
3.Secondary Outcome
Title Progression Free Survival(PFS)
Hide Description 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;
Time Frame June 2005 to October 5, 2009
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Bevacizumab and Erlotinib
Hide Arm/Group Description:
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 Number of Participants Analyzed 39
Median (Full Range)
Unit of Measure: months
4
(1 to 26.8)
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bevacizumab and Erlotinib
Hide Arm/Group Description 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
All-Cause Mortality
Bevacizumab and Erlotinib
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Bevacizumab and Erlotinib
Affected / at Risk (%) # Events
Total   12/40 (30.00%)    
Cardiac disorders   
Myocardial infarct † 1  1/40 (2.50%)  16
Possible Myocardial infarction † 1 [1]  1/40 (2.50%)  16
Abdominal fistula † 1  1/40 (2.50%)  16
Gastrointestinal disorders   
Hospitalization for partial bowel obstruction † 1  1/40 (2.50%)  16
Bowel perforation-large intestine † 1  1/40 (2.50%)  16
General disorders   
Hospitalization for dyspnea and fatigue † 1  1/40 (2.50%)  16
hospitalization for diarrhea, nausea, vomiting and facial rash (CTCAE grade 2) † 1  1/40 (2.50%)  16
Hospitalizaton for diarrhea, abdomianl bloating, dyspnea † 1 [2]  1/40 (2.50%)  16
Death * 1 [3]  1/40 (2.50%)  16
Nasal septal perforation † 1  1/40 (2.50%)  16
Hospitalization for intercranial bleed † 1 [4]  1/40 (2.50%)  16
Hospitalization for fever † 1  1/40 (2.50%)  16
Hospitilization for skin rash and pain † 1  1/40 (2.50%)  16
Hospitilization for weakness and low hemoglobin † 1  1/40 (2.50%)  16
Hospitalization for fatigue, dyspnea, weakness † 1  1/40 (2.50%)  16
Hospitalization for headache and parasthesis † 1  1/40 (2.50%)  16
†
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
This MI was never confirmed and the investigator does not believe it was actually and MI
[2]
Diagnosed as right pleural effusion
[3]
Death was due to disease progression and not study related
[4]
This was never able to be confirmed
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bevacizumab and Erlotinib
Affected / at Risk (%) # Events
Total   40/40 (100.00%)    
Blood and lymphatic system disorders   
Hemoglobin † 1 [1]  5/40 (12.50%)  5
Neutrophils/granuloctyes (ANC/AGC) † 1 [2]  4/40 (10.00%)  4
Platelets † 1 [3]  2/40 (5.00%)  2
Hemorrhage/Bleeding-Other † 1  3/40 (7.50%)  3
Edema:limb † 1  3/40 (7.50%)  3
Lymphatics-Other † 1  2/40 (5.00%)  2
Cardiac disorders   
Supraventricular and nodal arrhythmia † 1  2/40 (5.00%)  2
Hypertension † 1  10/40 (25.00%)  10
Eye disorders   
Dry Eye Syndrome † 1  5/40 (12.50%)  5
Ocular/Visual-Other † 1  4/40 (10.00%)  4
Blurred Vision † 1  4/40 (10.00%)  4
Gastrointestinal disorders   
Anorexia † 1  15/40 (37.50%)  15
Constipation † 1  4/40 (10.00%)  4
Dehydration † 1  3/40 (7.50%)  3
Diarrhea † 1  33/40 (82.50%)  33
Distension/bloating, abdominal † 1  8/40 (20.00%)  8
Dry mouth/salivary gland (xerostomia) † 1  2/40 (5.00%)  2
Dysphagia (difficulty swllowing) † 1  2/40 (5.00%)  2
Flatulence † 1  5/40 (12.50%)  5
Gastrointestinal-Other † 1  12/40 (30.00%)  12
Heartburn/dyspepsia † 1  7/40 (17.50%)  7
Hemorrhoids † 1  2/40 (5.00%)  2
Mucositis/stomatitis (clincal exam) † 1  2/40 (5.00%)  2
Mucositis/stomatitis (functional/symptomatic) † 1  6/40 (15.00%)  6
Nausea † 1  16/40 (40.00%)  16
Taste alteration dysgeusia) † 1  11/40 (27.50%)  11
Vomiting † 1  14/40 (35.00%)  14
Hemorrhage, GI † 1  7/40 (17.50%)  7
General disorders   
Constitutional Symptoms (Other) † 1  2/40 (5.00%)  2
Fatigue † 1  16/40 (40.00%)  16
Insomnia † 1  5/40 (12.50%)  5
Rigors/chills † 1  3/40 (7.50%)  3
Weight loss † 1  10/40 (25.00%)  10
Fever (in the absence of neutropenia) † 1 [4]  3/40 (7.50%)  3
Pain † 1  21/40 (52.50%)  21
Pain-Other † 1  9/40 (22.50%)  9
Immune system disorders   
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) † 1  7/40 (17.50%)  7
Allergy/Immunology-Other † 1  3/40 (7.50%)  3
Infections and infestations   
Infection † 1  11/40 (27.50%)  11
Infection (documented clinically or microbiologically) † 1 [5]  5/40 (12.50%)  5
Infection with normal ANC or Grade 1 or 2 neutrophils † 1  5/40 (12.50%)  5
Infection with unknown ANC † 1  7/40 (17.50%)  7
Metabolism and nutrition disorders   
Albumin, serum-low (hypoalbuminemia) † 1  27/40 (67.50%)  27
Alkaline phosphatase † 1  5/40 (12.50%)  5
ALT, SGPT (serum glutamic pyruvic transaminase) † 1 [6]  6/40 (15.00%)  6
AST, SGOT (serum glutamic oxaloacetic transaminase) † 1 [7]  6/40 (15.00%)  6
Bilirubin (hyperbilirubinemia) † 1  4/40 (10.00%)  4
Calcium, serum-low (hypocalcemia) † 1  2/40 (5.00%)  2
Creatinine † 1  7/40 (17.50%)  7
Glucose, serum-low (hypoglycemia) † 1  2/40 (5.00%)  2
Potassium, serum-high (hyperkalemia) † 1  2/40 (5.00%)  2
Proteinuria † 1  5/40 (12.50%)  5
Potassium, serum-low (hypokalemia) † 1  9/40 (22.50%)  9
Sodium, serum-low (hyponatremia) † 1  10/40 (25.00%)  10
Musculoskeletal and connective tissue disorders   
Muscle weakness, generalized or specific area (not due to neuropathy) † 1  6/40 (15.00%)  6
Musculoskeletal/Soft Tissue-Other † 1  8/40 (20.00%)  8
Nervous system disorders   
Ataxia (incoordination) † 1  2/40 (5.00%)  2
Dizziness † 1  7/40 (17.50%)  7
Neuropathy: cranial or sensory † 1  4/40 (10.00%)  4
Tremor † 1  2/40 (5.00%)  2
Psychiatric disorders   
Mood Alteration † 1  5/40 (12.50%)  5
Renal and urinary disorders   
Renal/Genitourinary-other † 1  6/40 (15.00%)  6
Urinary Frequency/Urgency † 1  2/40 (5.00%)  2
Reproductive system and breast disorders   
Vaginal mucositis † 1  2/40 (5.00%)  2
Respiratory, thoracic and mediastinal disorders   
Hemorrhage, pulmonary/upper respiratory † 1  5/40 (12.50%)  5
Cough † 1  8/40 (20.00%)  8
Dyspnea (shortness of breath) † 1  3/40 (7.50%)  3
Nasal cavity/paranasal sinus reactions † 1  10/40 (25.00%)  10
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) † 1  8/40 (20.00%)  8
Pulmonary/Upper Respiratory-Other † 1  8/40 (20.00%)  8
Skin and subcutaneous tissue disorders   
Dermatology/Skin - Other † 1  13/40 (32.50%)  13
Hair loss/alopecia (scalp or body) † 1  4/40 (10.00%)  4
Nail Changes † 1  3/40 (7.50%)  3
Pruritius/itching † 1  6/40 (15.00%)  6
Rash/desquamation † 1  9/40 (22.50%)  9
Rash: acne/acneiform † 1  31/40 (77.50%)  31
Rash: hand-foot skin reaction † 1  2/40 (5.00%)  2
Skin breakdown/decubitus ulcer † 1  3/40 (7.50%)  3
Dry Skin † 1  18/40 (45.00%)  18
Vascular disorders   
Vascular-Other † 1  3/40 (7.50%)  3
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Hemoglobin values out of normal range
[2]
Neutrophils/granulocytes out of normal range
[3]
Platelet count out of normal range
[4]
Neutropenia is defined as ANC<1.0x10e9/L
[5]
with Grade 3 or 4 neutrophils (ANC<1.0x10e)
[6]
Out of normal laboratory range
[7]
Outside of normal laboratory range
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Setsuko K. Chambers, M.D.
Organization: Arizona Cancer Center, University of Arizona
Phone: 520-626-0950
EMail: schambers@azcc.arizona.edu
Publications:
Layout table for additonal information
Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00130520    
Obsolete Identifiers: NCT00696670
Other Study ID Numbers: HSC #05-47;AVF3117s
First Submitted: August 12, 2005
First Posted: August 15, 2005
Results First Submitted: December 13, 2010
Results First Posted: December 14, 2010
Last Update Posted: May 28, 2012