Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00096278
First received: November 9, 2004
Last updated: May 16, 2014
Last verified: July 2013
Results First Received: October 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Adenocarcinoma of the Colon
Stage IIA Colon Cancer
Stage IIB Colon Cancer
Stage IIC Colon Cancer
Stage IIIA Colon Cancer
Stage IIIB Colon Cancer
Stage IIIC Colon Cancer
Interventions: Drug: oxaliplatin
Drug: leucovorin calcium
Drug: fluorouracil
Biological: bevacizumab

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil Oxaliplatin + Leucovorin + 5-Fluorouracil
Arm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab

Participant Flow:   Overall Study
    Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil     Arm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab  
STARTED     1356     1354  
COMPLETED     1338     1334  
NOT COMPLETED     18     20  
No follow-up data                 15                 18  
Patient not at risk for primary endpoint                 3                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Oxaliplatin + Leucovorin + 5-Fluorouracil Oxaliplatin + Leucovorin + 5-Fluorouracil
Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Total Total of all reporting groups

Baseline Measures
    Oxaliplatin + Leucovorin + 5-Fluorouracil     Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab     Total  
Number of Participants  
[units: participants]
  1356     1354     2710  
Age  
[units: years]
Mean ± Standard Deviation
  57  ± 11.6     56  ± 11.3     57  ± 11.4  
Gender  
[units: participants]
     
Female     680     678     1358  
Male     676     676     1352  



  Outcome Measures

1.  Primary:   Disease-free Survival   [ Time Frame: 3 years ]

2.  Secondary:   Survival as Assessed by Death From Any Cause   [ Time Frame: Every 6 months for 4 years and then every 12 months until death from any cause ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Proteinuria After Completion of Bevacizumab   [ Time Frame: For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Proteinuria With Clinical Sequelae   [ Time Frame: For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   The Risk Factors for Development of Proteinuria   [ Time Frame: For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   As Measured by Blood Pressure and Antihypertensive Medication Hypertension   [ Time Frame: Group 2, every 3 months for one year post treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

7.  Secondary:   Delayed Vascular Events Such as Myocardial Infarction, Central Nervous System (CNS) Ischemia, and Thrombosis in Patients Receiving Chemotherapy + Bevacizumab   [ Time Frame: Events measured regularly during chemotherapy and bevacizumab therapy ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

8.  Secondary:   Ovarian Function in Premenopausal Women as Measured by Serum Ovarian Function Test   [ Time Frame: Group 2: Measured pre-therapy and then every 6 months for 2 years following randomization ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

9.  Secondary:   Bevacizumab Immunogenicity and Post-treatment Serum Levels of Bevacizumab in Patients Receiving Bevacizumab   [ Time Frame: Group 2: Pre-therapy, every 2 weeks during chemotherapy/bevacizumab therapy, every 6 weeks during bevacizumab therapy and at 3 and 6 months after completion of bevacizumab therapy ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events
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Time Frame No text entered.
Additional Description Participants at Risk includes any patient who submitted an Adverse Event (AE) form.

Reporting Groups
  Description
Oxaliplatin + Leucovorin + 5-Fluorouracil Oxaliplatin + Leucovorin + 5-Fluorouracil
Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab

Serious Adverse Events
    Oxaliplatin + Leucovorin + 5-Fluorouracil     Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab  
Total, serious adverse events      
# participants affected / at risk     81/1326 (6.11%)     270/1334 (20.24%)  
Blood and lymphatic system disorders      
Anemia † 1    
# participants affected / at risk     3/1326 (0.23%)     3/1334 (0.22%)  
Blood and lymphatic system disorders - Other, specify † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Disseminated intravascular coagulation † 1    
# participants affected / at risk     1/1326 (0.08%)     0/1334 (0.00%)  
Febrile neutropenia † 1    
# participants affected / at risk     1/1326 (0.08%)     4/1334 (0.30%)  
Hemolysis † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Cardiac disorders      
Atrial fibrillation † 1    
# participants affected / at risk     3/1326 (0.23%)     4/1334 (0.30%)  
Cardiac arrest † 1    
# participants affected / at risk     2/1326 (0.15%)     0/1334 (0.00%)  
Cardiac disorders - Other, specify † 1    
# participants affected / at risk     0/1326 (0.00%)     2/1334 (0.15%)  
Chest pain - cardiac † 1    
# participants affected / at risk     0/1326 (0.00%)     2/1334 (0.15%)  
Conduction disorder † 1    
# participants affected / at risk     0/1326 (0.00%)     2/1334 (0.15%)  
Heart failure † 1    
# participants affected / at risk     0/1326 (0.00%)     2/1334 (0.15%)  
Myocardial infarction † 1    
# participants affected / at risk     7/1326 (0.53%)     9/1334 (0.67%)  
Pericardial effusion † 1    
# participants affected / at risk     1/1326 (0.08%)     0/1334 (0.00%)  
Sinus bradycardia † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Sinus tachycardia † 1    
# participants affected / at risk     0/1326 (0.00%)     6/1334 (0.45%)  
Supraventricular tachycardia † 1    
# participants affected / at risk     0/1326 (0.00%)     2/1334 (0.15%)  
Ventricular arrhythmia † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Ventricular fibrillation † 1    
# participants affected / at risk     3/1326 (0.23%)     1/1334 (0.07%)  
Acute coronary syndrome † 1    
# participants affected / at risk     0/1326 (0.00%)     4/1334 (0.30%)  
Left ventricular systolic dysfunction † 1    
# participants affected / at risk     1/1326 (0.08%)     5/1334 (0.37%)  
Ear and labyrinth disorders      
External ear inflammation † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Endocrine disorders      
Endocrine disorders - Other, specify † 1    
# participants affected / at risk     1/1326 (0.08%)     0/1334 (0.00%)  
Eye disorders      
Extraocular muscle paresis † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Eye disorders - Other, specify † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Retinal detachment † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Gastrointestinal disorders      
Abdominal distension † 1    
# participants affected / at risk     0/1326 (0.00%)     3/1334 (0.22%)  
Abdominal pain † 1    
# participants affected / at risk     1/1326 (0.08%)     15/1334 (1.12%)  
Ascites † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Colitis † 1    
# participants affected / at risk     1/1326 (0.08%)     6/1334 (0.45%)  
Colonic hemorrhage † 1    
# participants affected / at risk     1/1326 (0.08%)     1/1334 (0.07%)  
Colonic obstruction † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Colonic perforation † 1    
# participants affected / at risk     0/1326 (0.00%)     3/1334 (0.22%)  
Colonic stenosis † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Constipation † 1    
# participants affected / at risk     0/1326 (0.00%)     3/1334 (0.22%)  
Diarrhea † 1    
# participants affected / at risk     1/1326 (0.08%)     20/1334 (1.50%)  
Duodenal obstruction † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Duodenal perforation † 1    
# participants affected / at risk     1/1326 (0.08%)     1/1334 (0.07%)  
Duodenal ulcer † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Dyspepsia † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Enterocolitis † 1    
# participants affected / at risk     0/1326 (0.00%)     3/1334 (0.22%)  
Esophagitis † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Gastric ulcer † 1    
# participants affected / at risk     1/1326 (0.08%)     0/1334 (0.00%)  
Gastrointestinal disorders - Other, specify † 1    
# participants affected / at risk     0/1326 (0.00%)     4/1334 (0.30%)  
Gastrointestinal pain † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Ileus † 1    
# participants affected / at risk     1/1326 (0.08%)     8/1334 (0.60%)  
Mucositis oral † 1    
# participants affected / at risk     1/1326 (0.08%)     1/1334 (0.07%)  
Nausea † 1    
# participants affected / at risk     1/1326 (0.08%)     14/1334 (1.05%)  
Pancreatitis † 1    
# participants affected / at risk     0/1326 (0.00%)     3/1334 (0.22%)  
Proctitis † 1    
# participants affected / at risk     0/1326 (0.00%)     3/1334 (0.22%)  
Rectal hemorrhage † 1    
# participants affected / at risk     2/1326 (0.15%)     2/1334 (0.15%)  
Rectal pain † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Small intestinal obstruction † 1    
# participants affected / at risk     0/1326 (0.00%)     11/1334 (0.82%)  
Vomiting † 1    
# participants affected / at risk     1/1326 (0.08%)     16/1334 (1.20%)  
Lower gastrointestinal hemorrhage † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Duodenal hemorrhage † 1    
# participants affected / at risk     1/1326 (0.08%)     0/1334 (0.00%)  
Upper gastrointestinal hemorrhage † 1    
# participants affected / at risk     1/1326 (0.08%)     2/1334 (0.15%)  
Jejunal obstruction † 1    
# participants affected / at risk     0/1326 (0.00%)     2/1334 (0.15%)  
General disorders      
Chills † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Death NOS † 1    
# participants affected / at risk     0/1326 (0.00%)     4/1334 (0.30%)  
Edema face † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Fatigue † 1    
# participants affected / at risk     0/1326 (0.00%)     9/1334 (0.67%)  
Fever † 1    
# participants affected / at risk     0/1326 (0.00%)     3/1334 (0.22%)  
General disorders and administration site conditions - Other, specify † 1    
# participants affected / at risk     0/1326 (0.00%)     3/1334 (0.22%)  
Injection site reaction † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Sudden death NOS † 1    
# participants affected / at risk     2/1326 (0.15%)     4/1334 (0.30%)  
Edema limbs † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Non-cardiac chest pain † 1    
# participants affected / at risk     0/1326 (0.00%)     4/1334 (0.30%)  
Hepatobiliary disorders      
Cholecystitis † 1    
# participants affected / at risk     1/1326 (0.08%)     7/1334 (0.52%)  
Hepatobiliary disorders - Other, specify † 1    
# participants affected / at risk     0/1326 (0.00%)     2/1334 (0.15%)  
Infections and infestations      
Appendicitis † 1    
# participants affected / at risk     1/1326 (0.08%)     0/1334 (0.00%)  
Appendicitis perforated † 1    
# participants affected / at risk     1/1326 (0.08%)     0/1334 (0.00%)  
Bladder infection † 1    
# participants affected / at risk     0/1326 (0.00%)     2/1334 (0.15%)  
Catheter related infection † 1    
# participants affected / at risk     2/1326 (0.15%)     8/1334 (0.60%)  
Infections and infestations - Other, specify † 1    
# participants affected / at risk     2/1326 (0.15%)     12/1334 (0.90%)  
Kidney infection † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Sepsis † 1    
# participants affected / at risk     1/1326 (0.08%)     1/1334 (0.07%)  
Skin infection † 1    
# participants affected / at risk     0/1326 (0.00%)     5/1334 (0.37%)  
Upper respiratory infection † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Urinary tract infection † 1    
# participants affected / at risk     0/1326 (0.00%)     3/1334 (0.22%)  
Wound infection † 1    
# participants affected / at risk     0/1326 (0.00%)     10/1334 (0.75%)  
Abdominal infection † 1    
# participants affected / at risk     2/1326 (0.15%)     3/1334 (0.22%)  
Peritoneal infection † 1    
# participants affected / at risk     0/1326 (0.00%)     2/1334 (0.15%)  
Pelvic infection † 1    
# participants affected / at risk     0/1326 (0.00%)     2/1334 (0.15%)  
Enterocolitis infectious † 1    
# participants affected / at risk     0/1326 (0.00%)     10/1334 (0.75%)  
Lung infection † 1    
# participants affected / at risk     3/1326 (0.23%)     10/1334 (0.75%)  
Anorectal infection † 1    
# participants affected / at risk     0/1326 (0.00%)     2/1334 (0.15%)  
Scrotal infection † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Small intestine infection † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Injury, poisoning and procedural complications      
Fracture † 1    
# participants affected / at risk     0/1326 (0.00%)     2/1334 (0.15%)  
Injury, poisoning and procedural complications - Other, specify † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Wound dehiscence † 1    
# participants affected / at risk     1/1326 (0.08%)     16/1334 (1.20%)  
Vascular access complication † 1    
# participants affected / at risk     5/1326 (0.38%)     25/1334 (1.87%)  
Large intestinal anastomotic leak † 1    
# participants affected / at risk     1/1326 (0.08%)     3/1334 (0.22%)  
Investigations      
Activated partial thromboplastin time prolonged † 1    
# participants affected / at risk     1/1326 (0.08%)     0/1334 (0.00%)  
Alanine aminotransferase increased (ALT/SGPT) † 1    
# participants affected / at risk     1/1326 (0.08%)     3/1334 (0.22%)  
Alkaline phosphatase increased † 1    
# participants affected / at risk     1/1326 (0.08%)     1/1334 (0.07%)  
Aspartate aminotransferase increased (AST/SGOT) † 1    
# participants affected / at risk     1/1326 (0.08%)     4/1334 (0.30%)  
Blood bilirubin increased † 1    
# participants affected / at risk     1/1326 (0.08%)     3/1334 (0.22%)  
Cardiac troponin I increased † 1    
# participants affected / at risk     2/1326 (0.15%)     6/1334 (0.45%)  
Cardiac troponin T increased † 1    
# participants affected / at risk     0/1326 (0.00%)     3/1334 (0.22%)  
Cholesterol high † 1    
# participants affected / at risk     2/1326 (0.15%)     0/1334 (0.00%)  
Creatinine increased † 1    
# participants affected / at risk     2/1326 (0.15%)     5/1334 (0.37%)  
Electrocardiogram QT corrected interval prolonged † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
INR increased † 1    
# participants affected / at risk     3/1326 (0.23%)     2/1334 (0.15%)  
Investigations - Other, specify † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Lipase increased † 1    
# participants affected / at risk     0/1326 (0.00%)     5/1334 (0.37%)  
Neutrophil count decreased † 1    
# participants affected / at risk     2/1326 (0.15%)     6/1334 (0.45%)  
Platelet count decreased † 1    
# participants affected / at risk     3/1326 (0.23%)     6/1334 (0.45%)  
Serum amylase increased † 1    
# participants affected / at risk     1/1326 (0.08%)     4/1334 (0.30%)  
Weight loss † 1    
# participants affected / at risk     0/1326 (0.00%)     4/1334 (0.30%)  
White blood cell decreased † 1    
# participants affected / at risk     2/1326 (0.15%)     6/1334 (0.45%)  
Metabolism and nutrition disorders      
Acidosis † 1    
# participants affected / at risk     1/1326 (0.08%)     4/1334 (0.30%)  
Anorexia † 1    
# participants affected / at risk     0/1326 (0.00%)     3/1334 (0.22%)  
Dehydration † 1    
# participants affected / at risk     2/1326 (0.15%)     22/1334 (1.65%)  
Hyperglycemia † 1    
# participants affected / at risk     6/1326 (0.45%)     9/1334 (0.67%)  
Hyperkalemia † 1    
# participants affected / at risk     0/1326 (0.00%)     2/1334 (0.15%)  
Hypertriglyceridemia † 1    
# participants affected / at risk     2/1326 (0.15%)     2/1334 (0.15%)  
Hyperuricemia † 1    
# participants affected / at risk     1/1326 (0.08%)     1/1334 (0.07%)  
Hypoalbuminemia † 1    
# participants affected / at risk     1/1326 (0.08%)     3/1334 (0.22%)  
Hypocalcemia † 1    
# participants affected / at risk     1/1326 (0.08%)     3/1334 (0.22%)  
Hypoglycemia † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Hypokalemia † 1    
# participants affected / at risk     0/1326 (0.00%)     9/1334 (0.67%)  
Hyponatremia † 1    
# participants affected / at risk     1/1326 (0.08%)     6/1334 (0.45%)  
Hypophosphatemia † 1    
# participants affected / at risk     0/1326 (0.00%)     4/1334 (0.30%)  
Glucose intolerance † 1    
# participants affected / at risk     0/1326 (0.00%)     2/1334 (0.15%)  
Musculoskeletal and connective tissue disorders      
Arthralgia † 1    
# participants affected / at risk     1/1326 (0.08%)     1/1334 (0.07%)  
Arthritis † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Back pain † 1    
# participants affected / at risk     1/1326 (0.08%)     4/1334 (0.30%)  
Myositis † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Neck pain † 1    
# participants affected / at risk     0/1326 (0.00%)     3/1334 (0.22%)  
Generalized muscle weakness † 1    
# participants affected / at risk     0/1326 (0.00%)     3/1334 (0.22%)  
Muscle weakness lower limb † 1    
# participants affected / at risk     1/1326 (0.08%)     1/1334 (0.07%)  
Pelvic soft tissue necrosis † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Nervous system disorders      
Depressed level of consciousness † 1    
# participants affected / at risk     0/1326 (0.00%)     2/1334 (0.15%)  
Dizziness † 1    
# participants affected / at risk     0/1326 (0.00%)     6/1334 (0.45%)  
Dysgeusia † 1    
# participants affected / at risk     0/1326 (0.00%)     2/1334 (0.15%)  
Headache † 1    
# participants affected / at risk     1/1326 (0.08%)     5/1334 (0.37%)  
Intracranial hemorrhage † 1    
# participants affected / at risk     2/1326 (0.15%)     1/1334 (0.07%)  
Ischemia cerebrovascular † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Nervous system disorders - Other, specify † 1    
# participants affected / at risk     4/1326 (0.30%)     7/1334 (0.52%)  
Peripheral motor neuropathy † 1    
# participants affected / at risk     1/1326 (0.08%)     2/1334 (0.15%)  
Peripheral sensory neuropathy † 1    
# participants affected / at risk     1/1326 (0.08%)     5/1334 (0.37%)  
Seizure † 1    
# participants affected / at risk     4/1326 (0.30%)     1/1334 (0.07%)  
Syncope † 1    
# participants affected / at risk     3/1326 (0.23%)     6/1334 (0.45%)  
Psychiatric disorders      
Anxiety † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Confusion † 1    
# participants affected / at risk     0/1326 (0.00%)     4/1334 (0.30%)  
Depression † 1    
# participants affected / at risk     0/1326 (0.00%)     2/1334 (0.15%)  
Renal and urinary disorders      
Hematuria † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Proteinuria † 1    
# participants affected / at risk     2/1326 (0.15%)     4/1334 (0.30%)  
Renal and urinary disorders - Other, specify † 1    
# participants affected / at risk     1/1326 (0.08%)     0/1334 (0.00%)  
Urinary retention † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Urinary tract obstruction † 1    
# participants affected / at risk     0/1326 (0.00%)     2/1334 (0.15%)  
Acute kidney injury † 1    
# participants affected / at risk     3/1326 (0.23%)     8/1334 (0.60%)  
Reproductive system and breast disorders      
Scrotal pain † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Uterine hemorrhage † 1    
# participants affected / at risk     0/1326 (0.00%)     2/1334 (0.15%)  
Vaginal hemorrhage † 1    
# participants affected / at risk     2/1326 (0.15%)     1/1334 (0.07%)  
Erectile dysfunction † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Respiratory, thoracic and mediastinal disorders      
Adult respiratory distress syndrome † 1    
# participants affected / at risk     2/1326 (0.15%)     1/1334 (0.07%)  
Aspiration † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Cough † 1    
# participants affected / at risk     0/1326 (0.00%)     3/1334 (0.22%)  
Dyspnea † 1    
# participants affected / at risk     3/1326 (0.23%)     13/1334 (0.97%)  
Epistaxis † 1    
# participants affected / at risk     2/1326 (0.15%)     0/1334 (0.00%)  
Hypoxia † 1    
# participants affected / at risk     2/1326 (0.15%)     4/1334 (0.30%)  
Pleural effusion † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Pneumonitis † 1    
# participants affected / at risk     1/1326 (0.08%)     7/1334 (0.52%)  
Pneumothorax † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Pulmonary fibrosis † 1    
# participants affected / at risk     2/1326 (0.15%)     4/1334 (0.30%)  
Sinus disorder † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Skin and subcutaneous tissue disorders      
Skin and subcutaneous tissue disorders - Other, specify † 1    
# participants affected / at risk     1/1326 (0.08%)     1/1334 (0.07%)  
Skin ulceration † 1    
# participants affected / at risk     0/1326 (0.00%)     2/1334 (0.15%)  
Vascular disorders      
Hematoma † 1    
# participants affected / at risk     1/1326 (0.08%)     0/1334 (0.00%)  
Hypertension † 1    
# participants affected / at risk     0/1326 (0.00%)     17/1334 (1.27%)  
Hypotension † 1    
# participants affected / at risk     0/1326 (0.00%)     4/1334 (0.30%)  
Peripheral ischemia † 1    
# participants affected / at risk     3/1326 (0.23%)     0/1334 (0.00%)  
Phlebitis † 1    
# participants affected / at risk     0/1326 (0.00%)     2/1334 (0.15%)  
Thromboembolic event † 1    
# participants affected / at risk     28/1326 (2.11%)     47/1334 (3.52%)  
Vascular disorders - Other, specify † 1    
# participants affected / at risk     2/1326 (0.15%)     1/1334 (0.07%)  
Vasculitis † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Visceral arterial ischemia † 1    
# participants affected / at risk     0/1326 (0.00%)     1/1334 (0.07%)  
Events were collected by systematic assessment
1 Term from vocabulary, CTCAE v4.0




  Other Adverse Events


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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
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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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director, Division of Regulatory Affairs
Organization: NSABP Foundation, Inc.
phone: 412-330-4600


No publications provided by National Cancer Institute (NCI)

Publications automatically indexed to this study:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00096278     History of Changes
Other Study ID Numbers: NCI-2012-03017, NSABP-C-08, U10CA012027
Study First Received: November 9, 2004
Results First Received: October 31, 2012
Last Updated: May 16, 2014
Health Authority: United States: Food and Drug Administration