Bevacizumab With Abraxane in Patients With Recurrent Ovarian/ Peritoneal Cancer

This study has been completed.
Sponsor:
Collaborators:
Genentech
Celgene Corporation
Information provided by (Responsible Party):
Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier:
NCT00407563
First received: December 4, 2006
Last updated: March 8, 2012
Last verified: March 2012
Results First Received: September 28, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Epithelial Ovarian Cancer
Primary Peritoneal Carcinoma
Interventions: Drug: Bevacizumab
Drug: Abraxane

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Informed consent was obtained from all subjects. All subjects underwent screening procedures to verify eligibility.

Reporting Groups
  Description
Bevacizumab and Abraxane 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.

Participant Flow:   Overall Study
    Bevacizumab and Abraxane  
STARTED     48  
COMPLETED     47 [1]
NOT COMPLETED     1  
Patient continues on treatment                 1  
[1] One patient remains on study treatment.



  Baseline Characteristics
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Reporting Groups
  Description
Bevacizumab and Abraxane 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.

Baseline Measures
    Bevacizumab and Abraxane  
Number of Participants  
[units: participants]
  48  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     26  
>=65 years     22  
Age  
[units: years]
Mean ± Standard Deviation
  61.6  ± 10.22  
Gender  
[units: participants]
 
Female     48  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     48  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   6-month Progression-Free Rate   [ Time Frame: 6 months after initiation of study treatment ]

2.  Secondary:   Best Overall Response   [ Time Frame: Radiologic imaging was repeated after every 3 cycles (about every 12 weeks) during study treatment, up to 31 months. ]

3.  Secondary:   Overall Survival   [ Time Frame: Overall survival is defined as the time from treatment start until death from any cause, assessed up to 40 months. ]

4.  Secondary:   Progression-free Survival (PFS)   [ 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. ]

5.  Secondary:   Best Overall Response at Six Months   [ Time Frame: Assessed over 6 months of study treatment ]


  Serious Adverse Events


  Other Adverse Events
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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.
Additional Description Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Bevacizumab and Abraxane 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.

Other Adverse Events
    Bevacizumab and Abraxane  
Total, other (not including serious) adverse events    
# participants affected / at risk     47/48  
Blood and lymphatic system disorders    
Anemia † 1  
# participants affected / at risk     10/48 (20.83%)  
Leukopenia † 1  
# participants affected / at risk     2/48 (4.17%)  
Lymphadenopathy † 1  
# participants affected / at risk     1/48 (2.08%)  
Lymphopenia † 1  
# participants affected / at risk     4/48 (8.33%)  
Neutropenia † 1  
# participants affected / at risk     14/48 (29.17%)  
Thrombocytopenia † 1  
# participants affected / at risk     1/48 (2.08%)  
Cardiac disorders    
Palpitations † 1  
# participants affected / at risk     1/48 (2.08%)  
Ear and labyrinth disorders    
External ear pain † 1  
# participants affected / at risk     1/48 (2.08%)  
Tinnitus † 1  
# participants affected / at risk     1/48 (2.08%)  
Eye disorders    
Blepharitis † 1  
# participants affected / at risk     1/48 (2.08%)  
Cataract † 1  
# participants affected / at risk     1/48 (2.08%)  
Diplopia † 1  
# participants affected / at risk     1/48 (2.08%)  
Dry eye † 1  
# participants affected / at risk     2/48 (4.17%)  
Erythema of eyelid † 1  
# participants affected / at risk     2/48 (4.17%)  
Eye hemorrhage † 1  
# participants affected / at risk     1/48 (2.08%)  
Lacrimation increased † 1  
# participants affected / at risk     4/48 (8.33%)  
Photopsia † 1  
# participants affected / at risk     2/48 (4.17%)  
Vision blurred † 1  
# participants affected / at risk     1/48 (2.08%)  
Gastrointestinal disorders    
Abdominal distension † 1  
# participants affected / at risk     1/48 (2.08%)  
Abdominal pain † 1  
# participants affected / at risk     11/48 (22.92%)  
Abdominal pain lower † 1  
# participants affected / at risk     2/48 (4.17%)  
Abdominal pain upper † 1  
# participants affected / at risk     3/48 (6.25%)  
Ascites † 1  
# participants affected / at risk     1/48 (2.08%)  
Colitis † 1  
# participants affected / at risk     1/48 (2.08%)  
Constipation † 1  
# participants affected / at risk     16/48 (33.33%)  
Diarrhea † 1  
# participants affected / at risk     16/48 (33.33%)  
Dry mouth † 1  
# participants affected / at risk     3/48 (6.25%)  
Dyspepsia † 1  
# participants affected / at risk     5/48 (10.42%)  
Feces hard † 1  
# participants affected / at risk     1/48 (2.08%)  
Gingival pain † 1  
# participants affected / at risk     1/48 (2.08%)  
Glossodynia † 1  
# participants affected / at risk     3/48 (6.25%)  
Hemorrhoids † 1  
# participants affected / at risk     2/48 (4.17%)  
Nausea † 1  
# participants affected / at risk     18/48 (37.50%)  
Oral pain † 1  
# participants affected / at risk     1/48 (2.08%)  
Paresthesia oral † 1  
# participants affected / at risk     1/48 (2.08%)  
Peritoneal and retroperitoneal disorders † 1  
# participants affected / at risk     1/48 (2.08%)  
Proctalgia † 1  
# participants affected / at risk     2/48 (4.17%)  
Rectal hemorrhage † 1  
# participants affected / at risk     1/48 (2.08%)  
Reflux gastritis † 1  
# participants affected / at risk     1/48 (2.08%)  
Small intestinal obstruction † 1  
# participants affected / at risk     1/48 (2.08%)  
Sore mouth † 1  
# participants affected / at risk     1/48 (2.08%)  
Stomatitis † 1  
# participants affected / at risk     11/48 (22.92%)  
Toothache † 1  
# participants affected / at risk     1/48 (2.08%)  
Vomiting † 1  
# participants affected / at risk     14/48 (29.17%)  
General disorders    
Asthenia † 1  
# participants affected / at risk     1/48 (2.08%)  
Catheter site inflammation † 1  
# participants affected / at risk     1/48 (2.08%)  
Chest pain † 1  
# participants affected / at risk     4/48 (8.33%)  
Chills † 1  
# participants affected / at risk     4/48 (8.33%)  
Fatigue † 1  
# participants affected / at risk     37/48 (77.08%)  
Inflammation † 1  
# participants affected / at risk     1/48 (2.08%)  
Influenza like illness † 1  
# participants affected / at risk     1/48 (2.08%)  
Injection site reaction † 1  
# participants affected / at risk     1/48 (2.08%)  
Local swelling † 1  
# participants affected / at risk     2/48 (4.17%)  
Localized edema † 1  
# participants affected / at risk     2/48 (4.17%)  
Malaise † 1  
# participants affected / at risk     1/48 (2.08%)  
Nodule † 1  
# participants affected / at risk     1/48 (2.08%)  
Edema peripheral † 1  
# participants affected / at risk     3/48 (6.25%)  
Pain † 1  
# participants affected / at risk     5/48 (10.42%)  
Pyrexia † 1  
# participants affected / at risk     1/48 (2.08%)  
Hepatobiliary disorders    
Hepatic pain † 1  
# participants affected / at risk     1/48 (2.08%)  
Hepatomegaly † 1  
# participants affected / at risk     1/48 (2.08%)  
Immune system disorders    
Hypersensitivity † 1  
# participants affected / at risk     2/48 (4.17%)  
Multiple allergies † 1  
# participants affected / at risk     2/48 (4.17%)  
Infections and infestations    
Bronchitis † 1  
# participants affected / at risk     1/48 (2.08%)  
Candidiasis † 1  
# participants affected / at risk     1/48 (2.08%)  
Catheter site infection † 1  
# participants affected / at risk     1/48 (2.08%)  
Cellulitis † 1  
# participants affected / at risk     1/48 (2.08%)  
Device related infection † 1  
# participants affected / at risk     1/48 (2.08%)  
Fungal infection † 1  
# participants affected / at risk     1/48 (2.08%)  
Gastroenteritis † 1  
# participants affected / at risk     1/48 (2.08%)  
Hand-foot-and-mouth disease † 1  
# participants affected / at risk     1/48 (2.08%)  
Infection † 1  
# participants affected / at risk     1/48 (2.08%)  
Laryngitis † 1  
# participants affected / at risk     1/48 (2.08%)  
Localized infection † 1  
# participants affected / at risk     2/48 (4.17%)  
Nasopharyngitis † 1  
# participants affected / at risk     4/48 (8.33%)  
Oral herpes † 1  
# participants affected / at risk     2/48 (4.17%)  
Pharyngitis streptococcal † 1  
# participants affected / at risk     1/48 (2.08%)  
Postpoperative wound infection † 1  
# participants affected / at risk     1/48 (2.08%)  
Rhinitis † 1  
# participants affected / at risk     1/48 (2.08%)  
Sepsis syndrome † 1  
# participants affected / at risk     1/48 (2.08%)  
Sialoadenitis † 1  
# participants affected / at risk     1/48 (2.08%)  
Sinusitis † 1  
# participants affected / at risk     7/48 (14.58%)  
Streptococcal infection † 1  
# participants affected / at risk     1/48 (2.08%)  
Tooth infection † 1  
# participants affected / at risk     1/48 (2.08%)  
Upper respiratory tract infection † 1  
# participants affected / at risk     8/48 (16.67%)  
Urinary tract infection † 1  
# participants affected / at risk     11/48 (22.92%)  
Vaginal infection † 1  
# participants affected / at risk     2/48 (4.17%)  
Vaginitis bacterial † 1  
# participants affected / at risk     1/48 (2.08%)  
Wound infection † 1  
# participants affected / at risk     1/48 (2.08%)  
Injury, poisoning and procedural complications    
Chest injury † 1  
# participants affected / at risk     1/48 (2.08%)  
Contusion † 1  
# participants affected / at risk     1/48 (2.08%)  
Joint sprain † 1  
# participants affected / at risk     2/48 (4.17%)  
Post procedural hemorrhage † 1  
# participants affected / at risk     1/48 (2.08%)  
Postoperative ileus † 1  
# participants affected / at risk     1/48 (2.08%)  
Procedural pain † 1  
# participants affected / at risk     1/48 (2.08%)  
Procedural site reaction † 1  
# participants affected / at risk     3/48 (6.25%)  
Skin laceration † 1  
# participants affected / at risk     1/48 (2.08%)  
Investigations    
Aspartate aminotransferase increased † 1  
# participants affected / at risk     2/48 (4.17%)  
Blood creatinine increased † 1  
# participants affected / at risk     1/48 (2.08%)  
Blood lactate dehydrogenase increased † 1  
# participants affected / at risk     2/48 (4.17%)  
Blood pressure increased † 1  
# participants affected / at risk     2/48 (4.17%)  
Blood thyroid stimulating hormone increased † 1  
# participants affected / at risk     1/48 (2.08%)  
Body temperature increased † 1  
# participants affected / at risk     4/48 (8.33%)  
C-reactive protein increased † 1  
# participants affected / at risk     1/48 (2.08%)  
CD4 lymphocytes increased † 1  
# participants affected / at risk     1/48 (2.08%)  
Forced expiratory volume † 1  
# participants affected / at risk     1/48 (2.08%)  
Hematocrit decreased † 1  
# participants affected / at risk     1/48 (2.08%)  
Hemoglobin decreased † 1  
# participants affected / at risk     2/48 (4.17%)  
Monoctye count increased † 1  
# participants affected / at risk     1/48 (2.08%)  
Neutrophil count decreased † 1  
# participants affected / at risk     4/48 (8.33%)  
Parasite stool test positive † 1  
# participants affected / at risk     1/48 (2.08%)  
Platelet count decreased † 1  
# participants affected / at risk     1/48 (2.08%)  
Red blood cell count decreased † 1  
# participants affected / at risk     1/48 (2.08%)  
White blood cell count decreased † 1  
# participants affected / at risk     4/48 (8.33%)  
Metabolism and nutrition disorders    
Decreased appetite † 1  
# participants affected / at risk     8/48 (16.67%)  
Dehydration † 1  
# participants affected / at risk     1/48 (2.08%)  
Fluid retention † 1  
# participants affected / at risk     1/48 (2.08%)  
Hypercalcemia † 1  
# participants affected / at risk     1/48 (2.08%)  
Hyperglycemia † 1  
# participants affected / at risk     4/48 (8.33%)  
Hyperkalemia † 1  
# participants affected / at risk     4/48 (8.33%)  
Hypermagnesemia † 1  
# participants affected / at risk     1/48 (2.08%)  
Hypernatremia † 1  
# participants affected / at risk     1/48 (2.08%)  
Hyperphosphatemia † 1  
# participants affected / at risk     1/48 (2.08%)  
Hypoglycemia † 1  
# participants affected / at risk     1/48 (2.08%)  
Hypokalemia † 1  
# participants affected / at risk     2/48 (4.17%)  
Hypomagnesemia † 1  
# participants affected / at risk     6/48 (12.50%)  
Hypophosphatemia † 1  
# participants affected / at risk     1/48 (2.08%)  
Weight loss poor † 1  
# participants affected / at risk     3/48 (6.25%)  
Musculoskeletal and connective tissue disorders    
Arthralgia † 1  
# participants affected / at risk     14/48 (29.17%)  
Arthritis † 1  
# participants affected / at risk     1/48 (2.08%)  
Back pain † 1  
# participants affected / at risk     5/48 (10.42%)  
Flank pain † 1  
# participants affected / at risk     1/48 (2.08%)  
Foot fracture † 1  
# participants affected / at risk     1/48 (2.08%)  
Groin pain † 1  
# participants affected / at risk     2/48 (4.17%)  
Joint stiffness † 1  
# participants affected / at risk     2/48 (4.17%)  
Joint swelling † 1  
# participants affected / at risk     2/48 (4.17%)  
Muscle spasms † 1  
# participants affected / at risk     3/48 (6.25%)  
Muscular weakness † 1  
# participants affected / at risk     2/48 (4.17%)  
Musculoskeletal discomfort † 1  
# participants affected / at risk     1/48 (2.08%)  
Musculoskeletal pain † 1  
# participants affected / at risk     3/48 (6.25%)  
Myalgia † 1  
# participants affected / at risk     6/48 (12.50%)  
Osteoporosis † 1  
# participants affected / at risk     1/48 (2.08%)  
Pain in extremity † 1  
# participants affected / at risk     9/48 (18.75%)  
Plantar fasciitis † 1  
# participants affected / at risk     1/48 (2.08%)  
Temporomandibular joint syndrome † 1  
# participants affected / at risk     1/48 (2.08%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Pituitary tumor benign † 1  
# participants affected / at risk     1/48 (2.08%)  
Nervous system disorders    
Dizziness † 1  
# participants affected / at risk     5/48 (10.42%)  
Dysgeusia † 1  
# participants affected / at risk     7/48 (14.58%)  
Encephalopathy † 1  
# participants affected / at risk     1/48 (2.08%)  
Headache † 1  
# participants affected / at risk     12/48 (25.00%)  
Hypoesthesia † 1  
# participants affected / at risk     4/48 (8.33%)  
Memory impairment † 1  
# participants affected / at risk     3/48 (6.25%)  
Nerve compression † 1  
# participants affected / at risk     1/48 (2.08%)  
Neuralgia † 1  
# participants affected / at risk     1/48 (2.08%)  
Neuropathy peripheral † 1  
# participants affected / at risk     15/48 (31.25%)  
Paresthesia † 1  
# participants affected / at risk     1/48 (2.08%)  
Sciatica † 1  
# participants affected / at risk     1/48 (2.08%)  
Sinus headache † 1  
# participants affected / at risk     2/48 (4.17%)  
Psychiatric disorders    
Anxiety † 1  
# participants affected / at risk     3/48 (6.25%)  
Depression † 1  
# participants affected / at risk     2/48 (4.17%)  
Disturbance in attention † 1  
# participants affected / at risk     1/48 (2.08%)  
Insomnia † 1  
# participants affected / at risk     9/48 (18.75%)  
Mood altered † 1  
# participants affected / at risk     1/48 (2.08%)  
Nightmare † 1  
# participants affected / at risk     1/48 (2.08%)  
Renal and urinary disorders    
Dysuria † 1  
# participants affected / at risk     6/48 (12.50%)  
Hematuria † 1  
# participants affected / at risk     1/48 (2.08%)  
Micturition urgency † 1  
# participants affected / at risk     1/48 (2.08%)  
Proteinuria † 1  
# participants affected / at risk     6/48 (12.50%)  
Urethral pain † 1  
# participants affected / at risk     1/48 (2.08%)  
Reproductive system and breast disorders    
Breast pain † 1  
# participants affected / at risk     1/48 (2.08%)  
Edema genital † 1  
# participants affected / at risk     1/48 (2.08%)  
Pelvic pain † 1  
# participants affected / at risk     1/48 (2.08%)  
Sexual dysfunction † 1  
# participants affected / at risk     1/48 (2.08%)  
Vaginal discharge † 1  
# participants affected / at risk     1/48 (2.08%)  
Vaginal hemorrhage † 1  
# participants affected / at risk     2/48 (4.17%)  
Vulvovaginal dryness † 1  
# participants affected / at risk     3/48 (6.25%)  
Vulvovaginal pruritis † 1  
# participants affected / at risk     1/48 (2.08%)  
Respiratory, thoracic and mediastinal disorders    
Asthma † 1  
# participants affected / at risk     1/48 (2.08%)  
Cough † 1  
# participants affected / at risk     11/48 (22.92%)  
Dysphonia † 1  
# participants affected / at risk     9/48 (18.75%)  
Dyspnea † 1  
# participants affected / at risk     10/48 (20.83%)  
Dyspnea exertional † 1  
# participants affected / at risk     3/48 (6.25%)  
Epistaxis † 1  
# participants affected / at risk     23/48 (47.92%)  
Hemoptysis † 1  
# participants affected / at risk     1/48 (2.08%)  
Nasal congestion † 1  
# participants affected / at risk     3/48 (6.25%)  
Oropharyngeal pain † 1  
# participants affected / at risk     5/48 (10.42%)  
Paranasal sinus discomfort † 1  
# participants affected / at risk     2/48 (4.17%)  
Pneumothorax † 1  
# participants affected / at risk     1/48 (2.08%)  
Postnasal drip † 1  
# participants affected / at risk     1/48 (2.08%)  
Respiratory tract congestion † 1  
# participants affected / at risk     1/48 (2.08%)  
Rhinitis allergic † 1  
# participants affected / at risk     2/48 (4.17%)  
Rhinorrhea † 1  
# participants affected / at risk     6/48 (12.50%)  
Sinus congestion † 1  
# participants affected / at risk     2/48 (4.17%)  
Sinus disorder † 1  
# participants affected / at risk     1/48 (2.08%)  
Sinus disorder, NOS † 1  
# participants affected / at risk     2/48 (4.17%)  
Skin and subcutaneous tissue disorders    
Acne † 1  
# participants affected / at risk     1/48 (2.08%)  
Alopecia † 1  
# participants affected / at risk     15/48 (31.25%)  
Blister † 1  
# participants affected / at risk     1/48 (2.08%)  
Dermatitis acneiform † 1  
# participants affected / at risk     1/48 (2.08%)  
Dry skin † 1  
# participants affected / at risk     1/48 (2.08%)  
Nail discoloration † 1  
# participants affected / at risk     1/48 (2.08%)  
Nail disorder † 1  
# participants affected / at risk     4/48 (8.33%)  
Onychomadesis † 1  
# participants affected / at risk     1/48 (2.08%)  
Pruritus † 1  
# participants affected / at risk     4/48 (8.33%)  
Rash † 1  
# participants affected / at risk     4/48 (8.33%)  
Skin discoloration † 1  
# participants affected / at risk     1/48 (2.08%)  
Skin disorder † 1  
# participants affected / at risk     1/48 (2.08%)  
Skin hyperpigmentation † 1  
# participants affected / at risk     1/48 (2.08%)  
Umbilical hemorrhage † 1  
# participants affected / at risk     1/48 (2.08%)  
Surgical and medical procedures    
Ileostomy † 1  
# participants affected / at risk     1/48 (2.08%)  
Tooth extraction † 1  
# participants affected / at risk     1/48 (2.08%)  
Vascular disorders    
Flushing † 1  
# participants affected / at risk     1/48 (2.08%)  
Hot flush † 1  
# participants affected / at risk     1/48 (2.08%)  
Hypertension † 1  
# participants affected / at risk     10/48 (20.83%)  
Hypotension † 1  
# participants affected / at risk     3/48 (6.25%)  
Events were collected by systematic assessment
1 Term from vocabulary, CTCAE (3.0)



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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Vice President of Scientific Affairs
Organization: Accelerated Community Oncology Research Network, Inc.
phone: 901-435-5570
e-mail: mwalker@acorncro.com


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Publications automatically indexed to this study:

Responsible Party: Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier: NCT00407563     History of Changes
Other Study ID Numbers: ACORN ALSSOPR0501
Study First Received: December 4, 2006
Results First Received: September 28, 2011
Last Updated: March 8, 2012
Health Authority: United States: Institutional Review Board