Bevacizumab With Abraxane in Patients With Recurrent Ovarian/ Peritoneal Cancer
This study has been completed.
Sponsor:
Accelerated Community Oncology Research Network
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
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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
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
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
| 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
| 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) |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided by Accelerated Community Oncology Research Network
Publications automatically indexed to this study:
| 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:
|
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
Organization: Accelerated Community Oncology Research Network, Inc.
phone: 901-435-5570
e-mail: mwalker@acorncro.com
No publications provided by Accelerated Community Oncology Research Network
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 |