Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 104 for:    colon cancer | ( Map: Nebraska, United States )

Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal 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: NCT00098787
Recruitment Status : Completed
First Posted : December 9, 2004
Results First Posted : June 27, 2014
Last Update Posted : August 21, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Biological: bevacizumab
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: Oxaliplatin
Enrollment 247
Recruitment Details This study was activated on July 14, 2005 and terminated on April 20, 2012, with 247 patients from 25 institutions enrolled to the study.
Pre-assignment Details Only 211 patients were registered to the treatment phase of the study, while the other 36 did not proceed because of ineligibility (n=9), patient withdrawal (n=6), unknown thymidylate synthase (TS)/insufficient sample (n=3), disease progression/decline in TS (n=2), Arm C suspended could not enter Step 2 (n =15), and no insurance (n =1).
Arm/Group Title Arm A (High TS, IROX/Bev) Arm B (High TS, FOLFOX/Bev) Arm C (Low or Intermediate TS, FOLFOX/Bev)
Hide Arm/Group Description Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met. Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met. Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
Period Title: Overall Study
Started 73 75 63
Treated 70 73 62
Eligible and Treated 61 66 59
Completed 0 0 0
Not Completed 73 75 63
Reason Not Completed
Never started treatment             3             2             1
Ineligible             9             7             3
Disease progression             28             17             23
Adverse Event             8             17             8
Death             6             1             0
Withdrawal by Subject             4             12             6
Alternative therapy             8             13             13
Other             7             6             9
Arm/Group Title Arm A (High TS, IROX/Bev) Arm B (High TS, FOLFOX/Bev) Arm C (Low or Intermediate TS, FOLFOX/Bev) Total
Hide Arm/Group Description Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met. Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met. Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B. Total of all reporting groups
Overall Number of Baseline Participants 61 66 59 186
Hide Baseline Analysis Population Description
Eligible and treated patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 61 participants 66 participants 59 participants 186 participants
61
(37 to 85)
60
(31 to 79)
59
(29 to 80)
60
(29 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 66 participants 59 participants 186 participants
Female
21
  34.4%
30
  45.5%
24
  40.7%
75
  40.3%
Male
40
  65.6%
36
  54.5%
35
  59.3%
111
  59.7%
Disease status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants 66 participants 59 participants 186 participants
Initial Diagnosis 50 50 50 150
Recurrence 11 16 9 36
1.Primary Outcome
Title Objective Response Rate
Hide Description Objective response rate is defined as proportion of patients who achieve complete response (CR) or partial response (PR). Response was assessed using Solid Tumor Response Criteria (RECIST). CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.
Time Frame Assessed every 3 months if the patient is within 2 years of registration and every 6 months up to 4 years post-registration.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Arm A (High TS, IROX/Bev) Arm B (High TS, FOLFOX/Bev) Arm C (Low or Intermediate TS, FOLFOX/Bev)
Hide Arm/Group Description:
Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
Overall Number of Participants Analyzed 61 66 59
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: proportion
0.33
(0.23 to 0.44)
0.38
(0.28 to 0.49)
0.49
(0.38 to 0.61)
2.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description Progression-free survival is defined as time from randomization (to Arm A or Arm B) or registration (to Arm C) to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.
Time Frame Assessed every 3 months if the patient is within 2 years of registration and every 6 months once the patient is 2-4 years post-registration.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Arm A (High TS, IROX/Bev) Arm B (High TS, FOLFOX/Bev) Arm C (Low or Intermediate TS, FOLFOX/Bev)
Hide Arm/Group Description:
Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
Overall Number of Participants Analyzed 61 66 59
Median (95% Confidence Interval)
Unit of Measure: months
10
(6 to 11)
9
(8 to 11)
13
(10 to 14)
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival is defined as time from randomization (to Arm A or Arm B) or registration (to Arm C) to death. Patients alive at last follow-up were censored.
Time Frame Assessed every 3 months if the patient is within 2 years of registration and every 6 months once the patient is 2-4 years post-registration.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Arm A (High TS, IROX/Bev) Arm B (High TS, FOLFOX/Bev) Arm C (Low or Intermediate TS, FOLFOX/Bev)
Hide Arm/Group Description:
Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
Overall Number of Participants Analyzed 61 66 59
Median (95% Confidence Interval)
Unit of Measure: months
18
(14 to 23)
21
(16 to 32)
32
(23 to 44)
Time Frame Assessed every 28 days while on treatment and for 30 days after the end of treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High TS: IROX/Bev High TS: FOLFOX/Bev Low or Indeterminate TS: FOLFOX/Bev
Hide Arm/Group Description Patients with high thymidylate synthase (TS) who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol. Patients with high thymidylate synthase (TS) who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in arm I, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met. Patients with low or intermediate thymidylate synthase (TS) receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
All-Cause Mortality
High TS: IROX/Bev High TS: FOLFOX/Bev Low or Indeterminate TS: FOLFOX/Bev
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
High TS: IROX/Bev High TS: FOLFOX/Bev Low or Indeterminate TS: FOLFOX/Bev
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   49/70 (70.00%)   53/73 (72.60%)   43/62 (69.35%) 
Blood and lymphatic system disorders       
Anemia  1  3/70 (4.29%)  1/73 (1.37%)  2/62 (3.23%) 
Febrile neutropenia  1  0/70 (0.00%)  0/73 (0.00%)  2/62 (3.23%) 
Cardiac disorders       
Acute coronary syndrome  1  0/70 (0.00%)  0/73 (0.00%)  1/62 (1.61%) 
Heart failure  1  1/70 (1.43%)  0/73 (0.00%)  0/62 (0.00%) 
Pericardial effusion  1  0/70 (0.00%)  1/73 (1.37%)  0/62 (0.00%) 
Cardiac disorders - Other, specify  1  0/70 (0.00%)  1/73 (1.37%)  0/62 (0.00%) 
Gastrointestinal disorders       
Colitis  1  2/70 (2.86%)  0/73 (0.00%)  0/62 (0.00%) 
Constipation  1  0/70 (0.00%)  2/73 (2.74%)  1/62 (1.61%) 
Diarrhea  1  9/70 (12.86%)  2/73 (2.74%)  7/62 (11.29%) 
Abdominal distension  1  1/70 (1.43%)  0/73 (0.00%)  0/62 (0.00%) 
Dysphagia  1  0/70 (0.00%)  0/73 (0.00%)  1/62 (1.61%) 
Esophagitis  1  1/70 (1.43%)  0/73 (0.00%)  0/62 (0.00%) 
Rectal fistula  1  0/70 (0.00%)  1/73 (1.37%)  0/62 (0.00%) 
Ileus  1  0/70 (0.00%)  1/73 (1.37%)  0/62 (0.00%) 
Mucositis oral  1  0/70 (0.00%)  2/73 (2.74%)  1/62 (1.61%) 
Nausea  1  2/70 (2.86%)  2/73 (2.74%)  2/62 (3.23%) 
Colonic obstruction  1  2/70 (2.86%)  0/73 (0.00%)  1/62 (1.61%) 
Small intestinal obstruction  1  0/70 (0.00%)  1/73 (1.37%)  0/62 (0.00%) 
Colonic perforation  1  0/70 (0.00%)  3/73 (4.11%)  2/62 (3.23%) 
Rectal perforation  1  0/70 (0.00%)  0/73 (0.00%)  0/62 (0.00%) 
Typhlitis  1  1/70 (1.43%)  0/73 (0.00%)  0/62 (0.00%) 
Vomiting  1  0/70 (0.00%)  4/73 (5.48%)  0/62 (0.00%) 
Gastrointestinal disorders - Other, spec  1  1/70 (1.43%)  0/73 (0.00%)  0/62 (0.00%) 
Gastric hemorrhage  1  0/70 (0.00%)  1/73 (1.37%)  0/62 (0.00%) 
Abdominal pain  1  1/70 (1.43%)  5/73 (6.85%)  0/62 (0.00%) 
General disorders       
Fatigue  1  15/70 (21.43%)  7/73 (9.59%)  4/62 (6.45%) 
Chills  1  1/70 (1.43%)  0/73 (0.00%)  0/62 (0.00%) 
Death NOS  1  1/70 (1.43%)  0/73 (0.00%)  0/62 (0.00%) 
Sudden death NOS  1  1/70 (1.43%)  0/73 (0.00%)  0/62 (0.00%) 
Immune system disorders       
Anaphylaxis  1  2/70 (2.86%)  2/73 (2.74%)  1/62 (1.61%) 
Infections and infestations       
Enterocolitis infectious  1  0/70 (0.00%)  1/73 (1.37%)  0/62 (0.00%) 
Infections and infestations - Other, spe  1  1/70 (1.43%)  0/73 (0.00%)  0/62 (0.00%) 
Infections and infestations - Other, spe  1  0/70 (0.00%)  1/73 (1.37%)  0/62 (0.00%) 
Abdominal infection  1  0/70 (0.00%)  0/73 (0.00%)  1/62 (1.61%) 
Tooth infection  1  0/70 (0.00%)  0/73 (0.00%)  1/62 (1.61%) 
Lung infection  1  0/70 (0.00%)  2/73 (2.74%)  0/62 (0.00%) 
Wound infection  1  0/70 (0.00%)  0/73 (0.00%)  0/62 (0.00%) 
Infections and infestations - Other, spe  1  2/70 (2.86%)  3/73 (4.11%)  0/62 (0.00%) 
Injury, poisoning and procedural complications       
Vascular access complication  1  1/70 (1.43%)  1/73 (1.37%)  0/62 (0.00%) 
Injury to superior vena cava  1  0/70 (0.00%)  0/73 (0.00%)  1/62 (1.61%) 
Investigations       
White blood cell decreased  1  12/70 (17.14%)  4/73 (5.48%)  7/62 (11.29%) 
Neutrophil count decreased  1  16/70 (22.86%)  28/73 (38.36%)  21/62 (33.87%) 
Platelet count decreased  1  1/70 (1.43%)  0/73 (0.00%)  1/62 (1.61%) 
Weight loss  1  0/70 (0.00%)  0/73 (0.00%)  2/62 (3.23%) 
Alkaline phosphatase increased  1  1/70 (1.43%)  1/73 (1.37%)  0/62 (0.00%) 
Alanine aminotransferase increased  1  1/70 (1.43%)  0/73 (0.00%)  1/62 (1.61%) 
Aspartate aminotransferase increased  1  1/70 (1.43%)  2/73 (2.74%)  1/62 (1.61%) 
Blood bilirubin increased  1  0/70 (0.00%)  1/73 (1.37%)  0/62 (0.00%) 
Creatinine increased  1  0/70 (0.00%)  1/73 (1.37%)  0/62 (0.00%) 
Metabolism and nutrition disorders       
Anorexia  1  2/70 (2.86%)  1/73 (1.37%)  1/62 (1.61%) 
Dehydration  1  4/70 (5.71%)  1/73 (1.37%)  2/62 (3.23%) 
Hypoalbuminemia  1  1/70 (1.43%)  0/73 (0.00%)  1/62 (1.61%) 
Alkalosis  1  0/70 (0.00%)  0/73 (0.00%)  1/62 (1.61%) 
Hypocalcemia  1  0/70 (0.00%)  1/73 (1.37%)  0/62 (0.00%) 
Hyperglycemia  1  0/70 (0.00%)  1/73 (1.37%)  2/62 (3.23%) 
Hypokalemia  1  1/70 (1.43%)  4/73 (5.48%)  1/62 (1.61%) 
Hyponatremia  1  1/70 (1.43%)  0/73 (0.00%)  0/62 (0.00%) 
Nervous system disorders       
Ataxia  1  0/70 (0.00%)  1/73 (1.37%)  0/62 (0.00%) 
Peripheral motor neuropathy  1  1/70 (1.43%)  0/73 (0.00%)  1/62 (1.61%) 
Peripheral sensory neuropathy  1  8/70 (11.43%)  12/73 (16.44%)  15/62 (24.19%) 
Nervous system disorders - Other, specif  1  1/70 (1.43%)  0/73 (0.00%)  0/62 (0.00%) 
Headache  1  1/70 (1.43%)  1/73 (1.37%)  0/62 (0.00%) 
Psychiatric disorders       
Anxiety  1  1/70 (1.43%)  0/73 (0.00%)  0/62 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Epistaxis  1  0/70 (0.00%)  0/73 (0.00%)  1/62 (1.61%) 
Dyspnea  1  2/70 (2.86%)  2/73 (2.74%)  0/62 (0.00%) 
Hypoxia  1  0/70 (0.00%)  1/73 (1.37%)  0/62 (0.00%) 
Pleural effusion  1  1/70 (1.43%)  0/73 (0.00%)  0/62 (0.00%) 
Pneumonitis  1  1/70 (1.43%)  0/73 (0.00%)  1/62 (1.61%) 
Pulmonary fibrosis  1  0/70 (0.00%)  1/73 (1.37%)  0/62 (0.00%) 
Voice alteration  1  1/70 (1.43%)  0/73 (0.00%)  0/62 (0.00%) 
Respiratory, thoracic and mediastinal di  1  1/70 (1.43%)  0/73 (0.00%)  0/62 (0.00%) 
Skin and subcutaneous tissue disorders       
Dry skin  1  0/70 (0.00%)  0/73 (0.00%)  1/62 (1.61%) 
Rash maculo-papular  1  0/70 (0.00%)  1/73 (1.37%)  0/62 (0.00%) 
Palmar-plantar erythrodysesthesia syndro  1  0/70 (0.00%)  1/73 (1.37%)  4/62 (6.45%) 
Vascular disorders       
Hypertension  1  3/70 (4.29%)  4/73 (5.48%)  5/62 (8.06%) 
Hypotension  1  1/70 (1.43%)  0/73 (0.00%)  0/62 (0.00%) 
Thromboembolic event  1  4/70 (5.71%)  7/73 (9.59%)  5/62 (8.06%) 
Indicates events were collected by 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 5%
High TS: IROX/Bev High TS: FOLFOX/Bev Low or Indeterminate TS: FOLFOX/Bev
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   70/70 (100.00%)   73/73 (100.00%)   62/62 (100.00%) 
Blood and lymphatic system disorders       
Anemia  1  54/70 (77.14%)  56/73 (76.71%)  51/62 (82.26%) 
Gastrointestinal disorders       
Constipation  1  20/70 (28.57%)  23/73 (31.51%)  21/62 (33.87%) 
Diarrhea  1  48/70 (68.57%)  42/73 (57.53%)  38/62 (61.29%) 
Dry mouth  1  7/70 (10.00%)  1/73 (1.37%)  4/62 (6.45%) 
Dyspepsia  1  6/70 (8.57%)  9/73 (12.33%)  4/62 (6.45%) 
Mucositis oral  1  14/70 (20.00%)  25/73 (34.25%)  22/62 (35.48%) 
Nausea  1  44/70 (62.86%)  51/73 (69.86%)  34/62 (54.84%) 
Vomiting  1  34/70 (48.57%)  18/73 (24.66%)  11/62 (17.74%) 
Gastrointestinal disorders - Other, spec  1  4/70 (5.71%)  0/73 (0.00%)  2/62 (3.23%) 
Gastric hemorrhage  1  1/70 (1.43%)  1/73 (1.37%)  5/62 (8.06%) 
Abdominal pain  1  13/70 (18.57%)  11/73 (15.07%)  10/62 (16.13%) 
General disorders       
Fatigue  1  44/70 (62.86%)  60/73 (82.19%)  49/62 (79.03%) 
Fever  1  9/70 (12.86%)  5/73 (6.85%)  3/62 (4.84%) 
Chills  1  5/70 (7.14%)  7/73 (9.59%)  6/62 (9.68%) 
Immune system disorders       
Allergic reaction  1  7/70 (10.00%)  3/73 (4.11%)  0/62 (0.00%) 
Investigations       
White blood cell decreased  1  39/70 (55.71%)  49/73 (67.12%)  43/62 (69.35%) 
Neutrophil count decreased  1  32/70 (45.71%)  39/73 (53.42%)  33/62 (53.23%) 
Platelet count decreased  1  25/70 (35.71%)  41/73 (56.16%)  33/62 (53.23%) 
Weight loss  1  15/70 (21.43%)  14/73 (19.18%)  13/62 (20.97%) 
Alkaline phosphatase increased  1  7/70 (10.00%)  9/73 (12.33%)  8/62 (12.90%) 
Alanine aminotransferase increased  1  4/70 (5.71%)  5/73 (6.85%)  1/62 (1.61%) 
Aspartate aminotransferase increased  1  24/70 (34.29%)  34/73 (46.58%)  29/62 (46.77%) 
Blood bilirubin increased  1  1/70 (1.43%)  14/73 (19.18%)  8/62 (12.90%) 
Creatinine increased  1  12/70 (17.14%)  12/73 (16.44%)  13/62 (20.97%) 
Metabolism and nutrition disorders       
Anorexia  1  33/70 (47.14%)  30/73 (41.10%)  28/62 (45.16%) 
Dehydration  1  7/70 (10.00%)  8/73 (10.96%)  6/62 (9.68%) 
Hypoalbuminemia  1  34/70 (48.57%)  29/73 (39.73%)  29/62 (46.77%) 
Hypocalcemia  1  3/70 (4.29%)  4/73 (5.48%)  1/62 (1.61%) 
Hyperglycemia  1  2/70 (2.86%)  5/73 (6.85%)  4/62 (6.45%) 
Hypokalemia  1  8/70 (11.43%)  6/73 (8.22%)  2/62 (3.23%) 
Hyponatremia  1  2/70 (2.86%)  7/73 (9.59%)  3/62 (4.84%) 
Musculoskeletal and connective tissue disorders       
Generalized muscle weakness  1  5/70 (7.14%)  4/73 (5.48%)  4/62 (6.45%) 
Arthralgia  1  5/70 (7.14%)  1/73 (1.37%)  3/62 (4.84%) 
Myalgia  1  1/70 (1.43%)  6/73 (8.22%)  2/62 (3.23%) 
Nervous system disorders       
Dysgeusia  1  14/70 (20.00%)  23/73 (31.51%)  14/62 (22.58%) 
Dizziness  1  11/70 (15.71%)  4/73 (5.48%)  4/62 (6.45%) 
Peripheral sensory neuropathy  1  51/70 (72.86%)  62/73 (84.93%)  47/62 (75.81%) 
Headache  1  6/70 (8.57%)  11/73 (15.07%)  7/62 (11.29%) 
Psychiatric disorders       
Insomnia  1  7/70 (10.00%)  8/73 (10.96%)  7/62 (11.29%) 
Anxiety  1  6/70 (8.57%)  1/73 (1.37%)  1/62 (1.61%) 
Depression  1  5/70 (7.14%)  3/73 (4.11%)  2/62 (3.23%) 
Renal and urinary disorders       
Proteinuria  1  6/70 (8.57%)  15/73 (20.55%)  12/62 (19.35%) 
Respiratory, thoracic and mediastinal disorders       
Epistaxis  1  14/70 (20.00%)  23/73 (31.51%)  16/62 (25.81%) 
Cough  1  1/70 (1.43%)  3/73 (4.11%)  4/62 (6.45%) 
Dyspnea  1  5/70 (7.14%)  8/73 (10.96%)  11/62 (17.74%) 
Voice alteration  1  4/70 (5.71%)  5/73 (6.85%)  2/62 (3.23%) 
Skin and subcutaneous tissue disorders       
Dry skin  1  2/70 (2.86%)  4/73 (5.48%)  3/62 (4.84%) 
Alopecia  1  30/70 (42.86%)  22/73 (30.14%)  13/62 (20.97%) 
Skin hyperpigmentation  1  5/70 (7.14%)  5/73 (6.85%)  3/62 (4.84%) 
Nail loss  1  2/70 (2.86%)  4/73 (5.48%)  8/62 (12.90%) 
Pruritus  1  3/70 (4.29%)  6/73 (8.22%)  4/62 (6.45%) 
Rash maculo-papular  1  7/70 (10.00%)  10/73 (13.70%)  2/62 (3.23%) 
Palmar-plantar erythrodysesthesia syndro  1  1/70 (1.43%)  10/73 (13.70%)  12/62 (19.35%) 
Vascular disorders       
Hypertension  1  16/70 (22.86%)  20/73 (27.40%)  9/62 (14.52%) 
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 NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Study Statistician
Organization: Eastern Cooperative Oncology Group (ECOG) Statistical Office
Phone: 617-632-3012
Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00098787     History of Changes
Other Study ID Numbers: CDR0000398096
E4203 ( Other Identifier: Eastern Cooperative Oncology Group (ECOG) )
U10CA021115 ( U.S. NIH Grant/Contract )
First Submitted: December 8, 2004
First Posted: December 9, 2004
Results First Submitted: May 27, 2014
Results First Posted: June 27, 2014
Last Update Posted: August 21, 2018