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Trial record 19 of 526 for:    "Primary Peritoneal Carcinoma"

Bevacizumab With Abraxane in Patients With Recurrent Ovarian/ Peritoneal 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: NCT00407563
Recruitment Status : Completed
First Posted : December 5, 2006
Results First Posted : April 5, 2012
Last Update Posted : April 5, 2012
Sponsor:
Collaborators:
Genentech, Inc.
Celgene Corporation
Information provided by (Responsible Party):
Accelerated Community Oncology Research Network

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Epithelial Ovarian Cancer
Primary Peritoneal Carcinoma
Interventions Drug: Bevacizumab
Drug: Abraxane
Enrollment 48
Recruitment Details 9 community oncology research sites across the US within the ACORN network participated in this study. Enrollment started in January 2007 and was completed in December 2008.
Pre-assignment Details Informed consent was obtained from all subjects. All subjects underwent screening procedures to verify eligibility.
Arm/Group Title Bevacizumab and Abraxane
Hide Arm/Group Description All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
Period Title: Overall Study
Started 48
Completed 47 [1]
Not Completed 1
Reason Not Completed
Patient continues on treatment             1
[1]
One patient remains on study treatment.
Arm/Group Title Bevacizumab and Abraxane
Hide Arm/Group Description All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
Overall Number of Baseline Participants 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
<=18 years
0
   0.0%
Between 18 and 65 years
26
  54.2%
>=65 years
22
  45.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants
61.6  (10.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Female
48
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 48 participants
48
1.Primary Outcome
Title 6-month Progression-Free Rate
Hide Description Progression-free rate is defined as the percentage of participants with no progression event at 6 months after starting study treatment. An event for this endpoint was defined as a progression-free survival event occurring earlier than six months, or discontinuation of treatment earlier than six months for any other reason. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.
Time Frame 6 months after initiation of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bevacizumab and Abraxane
Hide Arm/Group Description:
All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
Overall Number of Participants Analyzed 48
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
62.5
(47.8 to 77.2)
2.Secondary Outcome
Title Best Overall Response
Hide Description Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR+PR.
Time Frame Radiologic imaging was repeated after every 3 cycles (about every 12 weeks) during study treatment, up to 31 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bevacizumab and Abraxane
Hide Arm/Group Description:
All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: Participants
Complete response 4
Partial response 20
Stable disease 14
Progressive disease 8
Not evaluable 2
3.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame Overall survival is defined as the time from treatment start until death from any cause, assessed up to 40 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had not experienced death during or after stopping treatment were censored in the analysis.
Arm/Group Title Bevacizumab and Abraxane
Hide Arm/Group Description:
All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
Overall Number of Participants Analyzed 48
Median (95% Confidence Interval)
Unit of Measure: Months
17.15
(13.57 to 23.82)
4.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description Disease progression was determined through radiology imaging measurements and by clinical or symptomatic progression during or after treatment. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.
Time Frame PFS was measured from day 1 of treatment until time of progression (assessed every 12 weeks) or death, whichever came first, assessed up to 30 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had not experienced either disease progression or death during or after stopping treatment were censored in the analysis.
Arm/Group Title Bevacizumab and Abraxane
Hide Arm/Group Description:
All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
Overall Number of Participants Analyzed 48
Median (95% Confidence Interval)
Unit of Measure: Months
8.08
(5.78 to 10.15)
5.Secondary Outcome
Title Best Overall Response at Six Months
Hide Description The outcome measure assessed the percentage of participants who had achieved either a Partial or Complete Response over 6 months of treatment. Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR+PR.
Time Frame Assessed over 6 months of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The 2 tailed, 95% confidence interval of the estimated response rate was calculated using the normal approximation to the binomial distribution.
Arm/Group Title Bevacizumab and Abraxane
Hide Arm/Group Description:
All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
Overall Number of Participants Analyzed 48
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
50
(34.8 to 65.1)
Time Frame Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 32 months.
Adverse Event Reporting Description Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
 
Arm/Group Title Bevacizumab and Abraxane
Hide Arm/Group Description All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
All-Cause Mortality
Bevacizumab and Abraxane
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab and Abraxane
Affected / at Risk (%)
Total   13/48 (27.08%) 
Blood and lymphatic system disorders   
Neutropenia * 1  1/48 (2.08%) 
Pancytopenia * 1  1/48 (2.08%) 
Cardiac disorders   
Cardio-respiratory arrest * 1  1/48 (2.08%) 
Gastrointestinal disorders   
Abdominal distension * 1  2/48 (4.17%) 
Abdominal pain * 1  2/48 (4.17%) 
Colitis * 1  1/48 (2.08%) 
Constipation * 1  1/48 (2.08%) 
Intestinal perforation * 1  1/48 (2.08%) 
Nausea * 1  1/48 (2.08%) 
Small intestinal obstruction * 1  5/48 (10.42%) 
Vomiting * 1  1/48 (2.08%) 
General disorders   
Hernia obstructive * 1  1/48 (2.08%) 
Pain * 1  1/48 (2.08%) 
Infections and infestations   
Bronchitis * 1  1/48 (2.08%) 
Candidiasis * 1  1/48 (2.08%) 
Gastroenteritis * 1  1/48 (2.08%) 
Pneumonia * 1  1/48 (2.08%) 
Injury, poisoning and procedural complications   
Overdoses * 1  1/48 (2.08%) 
Investigations   
Body temperature increased * 1  1/48 (2.08%) 
Metabolism and nutrition disorders   
Dehydration * 1  1/48 (2.08%) 
Renal and urinary disorders   
Renal failure acute * 1  1/48 (2.08%) 
Vascular disorders   
Deep vein thrombosis * 1  2/48 (4.17%) 
Hypotension * 1  1/48 (2.08%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bevacizumab and Abraxane
Affected / at Risk (%)
Total   47/48 (97.92%) 
Blood and lymphatic system disorders   
Anemia  1  10/48 (20.83%) 
Leukopenia  1  2/48 (4.17%) 
Lymphadenopathy  1  1/48 (2.08%) 
Lymphopenia  1  4/48 (8.33%) 
Neutropenia  1  14/48 (29.17%) 
Thrombocytopenia  1  1/48 (2.08%) 
Cardiac disorders   
Palpitations  1  1/48 (2.08%) 
Ear and labyrinth disorders   
External ear pain  1  1/48 (2.08%) 
Tinnitus  1  1/48 (2.08%) 
Eye disorders   
Blepharitis  1  1/48 (2.08%) 
Cataract  1  1/48 (2.08%) 
Diplopia  1  1/48 (2.08%) 
Dry eye  1  2/48 (4.17%) 
Erythema of eyelid  1  2/48 (4.17%) 
Eye hemorrhage  1  1/48 (2.08%) 
Lacrimation increased  1  4/48 (8.33%) 
Photopsia  1  2/48 (4.17%) 
Vision blurred  1  1/48 (2.08%) 
Gastrointestinal disorders   
Abdominal distension  1  1/48 (2.08%) 
Abdominal pain  1  11/48 (22.92%) 
Abdominal pain lower  1  2/48 (4.17%) 
Abdominal pain upper  1  3/48 (6.25%) 
Ascites  1  1/48 (2.08%) 
Colitis  1  1/48 (2.08%) 
Constipation  1  16/48 (33.33%) 
Diarrhea  1  16/48 (33.33%) 
Dry mouth  1  3/48 (6.25%) 
Dyspepsia  1  5/48 (10.42%) 
Feces hard  1  1/48 (2.08%) 
Gingival pain  1  1/48 (2.08%) 
Glossodynia  1  3/48 (6.25%) 
Hemorrhoids  1  2/48 (4.17%) 
Nausea  1  18/48 (37.50%) 
Oral pain  1  1/48 (2.08%) 
Paresthesia oral  1  1/48 (2.08%) 
Peritoneal and retroperitoneal disorders  1  1/48 (2.08%) 
Proctalgia  1  2/48 (4.17%) 
Rectal hemorrhage  1  1/48 (2.08%) 
Reflux gastritis  1  1/48 (2.08%) 
Small intestinal obstruction  1  1/48 (2.08%) 
Sore mouth  1  1/48 (2.08%) 
Stomatitis  1  11/48 (22.92%) 
Toothache  1  1/48 (2.08%) 
Vomiting  1  14/48 (29.17%) 
General disorders   
Asthenia  1  1/48 (2.08%) 
Catheter site inflammation  1  1/48 (2.08%) 
Chest pain  1  4/48 (8.33%) 
Chills  1  4/48 (8.33%) 
Fatigue  1  37/48 (77.08%) 
Inflammation  1  1/48 (2.08%) 
Influenza like illness  1  1/48 (2.08%) 
Injection site reaction  1  1/48 (2.08%) 
Local swelling  1  2/48 (4.17%) 
Localized edema  1  2/48 (4.17%) 
Malaise  1  1/48 (2.08%) 
Nodule  1  1/48 (2.08%) 
Edema peripheral  1  3/48 (6.25%) 
Pain  1  5/48 (10.42%) 
Pyrexia  1  1/48 (2.08%) 
Hepatobiliary disorders   
Hepatic pain  1  1/48 (2.08%) 
Hepatomegaly  1  1/48 (2.08%) 
Immune system disorders   
Hypersensitivity  1  2/48 (4.17%) 
Multiple allergies  1  2/48 (4.17%) 
Infections and infestations   
Bronchitis  1  1/48 (2.08%) 
Candidiasis  1  1/48 (2.08%) 
Catheter site infection  1  1/48 (2.08%) 
Cellulitis  1  1/48 (2.08%) 
Device related infection  1  1/48 (2.08%) 
Fungal infection  1  1/48 (2.08%) 
Gastroenteritis  1  1/48 (2.08%) 
Hand-foot-and-mouth disease  1  1/48 (2.08%) 
Infection  1  1/48 (2.08%) 
Laryngitis  1  1/48 (2.08%) 
Localized infection  1  2/48 (4.17%) 
Nasopharyngitis  1  4/48 (8.33%) 
Oral herpes  1  2/48 (4.17%) 
Pharyngitis streptococcal  1  1/48 (2.08%) 
Postpoperative wound infection  1  1/48 (2.08%) 
Rhinitis  1  1/48 (2.08%) 
Sepsis syndrome  1  1/48 (2.08%) 
Sialoadenitis  1  1/48 (2.08%) 
Sinusitis  1  7/48 (14.58%) 
Streptococcal infection  1  1/48 (2.08%) 
Tooth infection  1  1/48 (2.08%) 
Upper respiratory tract infection  1  8/48 (16.67%) 
Urinary tract infection  1  11/48 (22.92%) 
Vaginal infection  1  2/48 (4.17%) 
Vaginitis bacterial  1  1/48 (2.08%) 
Wound infection  1  1/48 (2.08%) 
Injury, poisoning and procedural complications   
Chest injury  1  1/48 (2.08%) 
Contusion  1  1/48 (2.08%) 
Joint sprain  1  2/48 (4.17%) 
Post procedural hemorrhage  1  1/48 (2.08%) 
Postoperative ileus  1  1/48 (2.08%) 
Procedural pain  1  1/48 (2.08%) 
Procedural site reaction  1  3/48 (6.25%) 
Skin laceration  1  1/48 (2.08%) 
Investigations   
Aspartate aminotransferase increased  1  2/48 (4.17%) 
Blood creatinine increased  1  1/48 (2.08%) 
Blood lactate dehydrogenase increased  1  2/48 (4.17%) 
Blood pressure increased  1  2/48 (4.17%) 
Blood thyroid stimulating hormone increased  1  1/48 (2.08%) 
Body temperature increased  1  4/48 (8.33%) 
C-reactive protein increased  1  1/48 (2.08%) 
CD4 lymphocytes increased  1  1/48 (2.08%) 
Forced expiratory volume  1  1/48 (2.08%) 
Hematocrit decreased  1  1/48 (2.08%) 
Hemoglobin decreased  1  2/48 (4.17%) 
Monoctye count increased  1  1/48 (2.08%) 
Neutrophil count decreased  1  4/48 (8.33%) 
Parasite stool test positive  1  1/48 (2.08%) 
Platelet count decreased  1  1/48 (2.08%) 
Red blood cell count decreased  1  1/48 (2.08%) 
White blood cell count decreased  1  4/48 (8.33%) 
Metabolism and nutrition disorders   
Decreased appetite  1  8/48 (16.67%) 
Dehydration  1  1/48 (2.08%) 
Fluid retention  1  1/48 (2.08%) 
Hypercalcemia  1  1/48 (2.08%) 
Hyperglycemia  1  4/48 (8.33%) 
Hyperkalemia  1  4/48 (8.33%) 
Hypermagnesemia  1  1/48 (2.08%) 
Hypernatremia  1  1/48 (2.08%) 
Hyperphosphatemia  1  1/48 (2.08%) 
Hypoglycemia  1  1/48 (2.08%) 
Hypokalemia  1  2/48 (4.17%) 
Hypomagnesemia  1  6/48 (12.50%) 
Hypophosphatemia  1  1/48 (2.08%) 
Weight loss poor  1  3/48 (6.25%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  14/48 (29.17%) 
Arthritis  1  1/48 (2.08%) 
Back pain  1  5/48 (10.42%) 
Flank pain  1  1/48 (2.08%) 
Foot fracture  1  1/48 (2.08%) 
Groin pain  1  2/48 (4.17%) 
Joint stiffness  1  2/48 (4.17%) 
Joint swelling  1  2/48 (4.17%) 
Muscle spasms  1  3/48 (6.25%) 
Muscular weakness  1  2/48 (4.17%) 
Musculoskeletal discomfort  1  1/48 (2.08%) 
Musculoskeletal pain  1  3/48 (6.25%) 
Myalgia  1  6/48 (12.50%) 
Osteoporosis  1  1/48 (2.08%) 
Pain in extremity  1  9/48 (18.75%) 
Plantar fasciitis  1  1/48 (2.08%) 
Temporomandibular joint syndrome  1  1/48 (2.08%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Pituitary tumor benign  1  1/48 (2.08%) 
Nervous system disorders   
Dizziness  1  5/48 (10.42%) 
Dysgeusia  1  7/48 (14.58%) 
Encephalopathy  1  1/48 (2.08%) 
Headache  1  12/48 (25.00%) 
Hypoesthesia  1  4/48 (8.33%) 
Memory impairment  1  3/48 (6.25%) 
Nerve compression  1  1/48 (2.08%) 
Neuralgia  1  1/48 (2.08%) 
Neuropathy peripheral  1  15/48 (31.25%) 
Paresthesia  1  1/48 (2.08%) 
Sciatica  1  1/48 (2.08%) 
Sinus headache  1  2/48 (4.17%) 
Psychiatric disorders   
Anxiety  1  3/48 (6.25%) 
Depression  1  2/48 (4.17%) 
Disturbance in attention  1  1/48 (2.08%) 
Insomnia  1  9/48 (18.75%) 
Mood altered  1  1/48 (2.08%) 
Nightmare  1  1/48 (2.08%) 
Renal and urinary disorders   
Dysuria  1  6/48 (12.50%) 
Hematuria  1  1/48 (2.08%) 
Micturition urgency  1  1/48 (2.08%) 
Proteinuria  1  6/48 (12.50%) 
Urethral pain  1  1/48 (2.08%) 
Reproductive system and breast disorders   
Breast pain  1  1/48 (2.08%) 
Edema genital  1  1/48 (2.08%) 
Pelvic pain  1  1/48 (2.08%) 
Sexual dysfunction  1  1/48 (2.08%) 
Vaginal discharge  1  1/48 (2.08%) 
Vaginal hemorrhage  1  2/48 (4.17%) 
Vulvovaginal dryness  1  3/48 (6.25%) 
Vulvovaginal pruritis  1  1/48 (2.08%) 
Respiratory, thoracic and mediastinal disorders   
Asthma  1  1/48 (2.08%) 
Cough  1  11/48 (22.92%) 
Dysphonia  1  9/48 (18.75%) 
Dyspnea  1  10/48 (20.83%) 
Dyspnea exertional  1  3/48 (6.25%) 
Epistaxis  1  23/48 (47.92%) 
Hemoptysis  1  1/48 (2.08%) 
Nasal congestion  1  3/48 (6.25%) 
Oropharyngeal pain  1  5/48 (10.42%) 
Paranasal sinus discomfort  1  2/48 (4.17%) 
Pneumothorax  1  1/48 (2.08%) 
Postnasal drip  1  1/48 (2.08%) 
Respiratory tract congestion  1  1/48 (2.08%) 
Rhinitis allergic  1  2/48 (4.17%) 
Rhinorrhea  1  6/48 (12.50%) 
Sinus congestion  1  2/48 (4.17%) 
Sinus disorder  1  1/48 (2.08%) 
Sinus disorder, NOS  1  2/48 (4.17%) 
Skin and subcutaneous tissue disorders   
Acne  1  1/48 (2.08%) 
Alopecia  1  15/48 (31.25%) 
Blister  1  1/48 (2.08%) 
Dermatitis acneiform  1  1/48 (2.08%) 
Dry skin  1  1/48 (2.08%) 
Nail discoloration  1  1/48 (2.08%) 
Nail disorder  1  4/48 (8.33%) 
Onychomadesis  1  1/48 (2.08%) 
Pruritus  1  4/48 (8.33%) 
Rash  1  4/48 (8.33%) 
Skin discoloration  1  1/48 (2.08%) 
Skin disorder  1  1/48 (2.08%) 
Skin hyperpigmentation  1  1/48 (2.08%) 
Umbilical hemorrhage  1  1/48 (2.08%) 
Surgical and medical procedures   
Ileostomy  1  1/48 (2.08%) 
Tooth extraction  1  1/48 (2.08%) 
Vascular disorders   
Flushing  1  1/48 (2.08%) 
Hot flush  1  1/48 (2.08%) 
Hypertension  1  10/48 (20.83%) 
Hypotension  1  3/48 (6.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Proposed publication must be submitted to Funder at least 60 days prior to the submission for publication. If Funder requests in writing, the proposed publication may be held for an additional 90 days.
Results Point of Contact
Name/Title: Vice President of Scientific Affairs
Organization: Accelerated Community Oncology Research Network, Inc.
Phone: 901-435-5570
Responsible Party: Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier: NCT00407563     History of Changes
Other Study ID Numbers: ACORN ALSSOPR0501
First Submitted: December 4, 2006
First Posted: December 5, 2006
Results First Submitted: September 28, 2011
Results First Posted: April 5, 2012
Last Update Posted: April 5, 2012