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Trial record 39 of 54 for:    colon cancer | ( Map: Mississippi, United States )

S0713: Oxaliplatin, Capecitabine, Cetuximab, and RT Followed By Surgery in Pts W/Stage II or III Rectal Cancer

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ClinicalTrials.gov Identifier: NCT00686166
Recruitment Status : Completed
First Posted : May 29, 2008
Results First Posted : February 24, 2016
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Biological: cetuximab
Drug: capecitabine
Drug: oxaliplatin
Procedure: therapeutic surgical procedure
Radiation: radiation therapy
Enrollment 83
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Chemo + Chemo and Radiation + Surgery
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Chemotherapy Cycle 1 (1 cycle is 35 days):

  • Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29
  • Cetuximab, 400 mg/m^2, IV, Day 1
  • Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29
  • Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)

Chemotherapy+ Radiation Cycle 2:

  • Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78
  • Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78
  • Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)
  • Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.

Therapeutic Surgical procedure: Resection

Period Title: Overall Study
Started 83
Eligible 78
Eligible and Began Protocol Therapy 74
Completed 63
Not Completed 20
Reason Not Completed
Adverse Event             7
Withdrawal by Subject             1
Progression/Relapse             1
Death             1
Not Protocol Specified             1
Ineligible             5
Did not begin protocol therapy             4
Arm/Group Title Chemo + Chemo and Radiation + Surgery
Hide Arm/Group Description

Chemotherapy Cycle 1 (1 cycle is 35 days):

  • Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29
  • Cetuximab, 400 mg/m^2, IV, Day 1
  • Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29
  • Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)

Chemotherapy+ Radiation Cycle 2:

  • Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78
  • Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78
  • Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)
  • Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.

Therapeutic Surgical procedure: Resection

Overall Number of Baseline Participants 74
Hide Baseline Analysis Population Description
Eligible patients who began protocol therapy.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 74 participants
56.4
(25.5 to 77.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants
Female
22
  29.7%
Male
52
  70.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants
Hispanic or Latino
6
   8.1%
Not Hispanic or Latino
67
  90.5%
Unknown or Not Reported
1
   1.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants
American Indian or Alaska Native
1
   1.4%
Asian
6
   8.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
   4.1%
White
63
  85.1%
More than one race
0
   0.0%
Unknown or Not Reported
1
   1.4%
1.Primary Outcome
Title Pathologic Complete Response Rate
Hide Description Pathologic response is evaluated after the patient has had surgery, and is based on local pathology review of the resected surgical specimen, according to the following: a) Pathologic complete response (pCR): on review of the resected rectal specimen and accompanying lymph nodes, no cancer is recognized by the pathologist; b) Microscopic cancer: gross tumor is not seen by the pathologist but tumor remains in the microscopic analysis of any part of the entire specimen; c) no response: gross cancer is found on pathologic examination of the resected rectal cancer and draining lymph nodes.
Time Frame 15-20 weeks from registration
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and analyzable patients with available data. It was assumed that a pathologic complete response was not achieved for patients who do not receive surgery or for whom a surgical specimen is lacking. These patients were included in the denominator.
Arm/Group Title Chemo + Chemo and Radiation + Surgery
Hide Arm/Group Description:

Chemotherapy Cycle 1 (1 cycle is 35 days):

  • Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29
  • Cetuximab, 400 mg/m^2, IV, Day 1
  • Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29
  • Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)

Chemotherapy+ Radiation Cycle 2:

  • Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78
  • Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78
  • Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)
  • Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.

Therapeutic Surgical procedure: Resection

Overall Number of Participants Analyzed 72
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25
(16 to 37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chemo + Chemo and Radiation + Surgery
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method Exact binomal test
Comments [Not Specified]
2.Secondary Outcome
Title 3-year Disease-free Survival
Hide Description From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and analyzable patients
Arm/Group Title Chemo + Chemo and Radiation + Surgery
Hide Arm/Group Description:

Chemotherapy Cycle 1 (1 cycle is 35 days):

  • Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29
  • Cetuximab, 400 mg/m^2, IV, Day 1
  • Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29
  • Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)

Chemotherapy+ Radiation Cycle 2:

  • Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78
  • Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78
  • Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)
  • Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.

Therapeutic Surgical procedure: Resection

Overall Number of Participants Analyzed 74
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
68
(57 to 78)
3.Secondary Outcome
Title Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Hide Description Only adverse events that are possibly, probably or definitely related to study regimen are reported.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received any treatment and were assessed for adverse events are included in this summary.
Arm/Group Title Chemotherapy Chemotherapy + Radiation Tumor Resection
Hide Arm/Group Description:
Patients receive oxaliplatin 50 mg/m^2 IV (Days 1, 8, 15, 22, 29), cetuximab 400 mg/m^2 IV (Day 1), cetuximab 250 mg/m^2 IV (Days 8, 15, 22, 29), capecitabine 1650 mg/m^2 PO (Monday-Friday, Day 1-35). Cycle is 35 days, followed by a 14-day break.
Patients receive oxaliplatin 50 mg/m^2 IV (Days 50, 57, 71, 78), cetuximab 250 mg/m^2 IV (Days 50, 57, 64, 71, 78), capecitabine 1650 mg/m^2 PO (Monday-Friday, Day 50-84). Radiation therapy begins on Day 50. Dose and length of treatment are dependent on technique used and clinical stage. Planned target value 1: 4500 cGy (centigray) in 25 fractions; Planned target value 2 (stage 3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
Surgery must take place between 3 – 8 weeks after completion of chemoradiation. Surgical resections should adhere to the principles of total mesorectal excision as described by Heald.
Overall Number of Participants Analyzed 74 68 63
Measure Type: Number
Unit of Measure: Participants
ALT, SGPT (serum glutamic pyruvic transaminase) 15 11 3
AST, SGOT 15 12 2
Acidosis (metabolic or respiratory) 1 0 0
Adult respiratory distress syndrome (ARDS) 1 0 0
Albumin, serum-low (hypoalbuminemia) 11 10 7
Alkaline phosphatase 4 5 3
Allergic reaction/hypersensitivity 0 1 0
Allergic rhinitis 2 1 0
Amylase 0 0 1
Anorexia 20 18 9
Bicarbonate, serum-low 1 1 2
Bilirubin (hyperbilirubinemia) 5 3 2
Blood/Bone Marrow-Other 2 1 1
Bone: spine-scoliosis 1 0 0
Bruising (in absence of Gr 3-4 thrombocytopenia) 0 1 0
Burn 0 2 0
Calcium, serum-low (hypocalcemia) 8 13 9
Coagulation-Other 1 0 0
Colitis 1 0 0
Confusion 2 0 0
Constipation 34 24 5
Constitutional Symptoms-Other 2 1 0
Cough 2 6 1
Creatinine 2 0 4
Cystitis 0 0 1
Cytokine release syndrome/acute infusion reaction 1 1 0
Dehydration 8 11 1
Dermatology/Skin-Other 1 2 0
Diarrhea 34 48 10
Distention/bloating, abdominal 0 1 0
Dizziness 10 7 1
Dry mouth/salivary gland (xerostomia) 7 6 0
Dry skin 20 16 2
Dysphagia (difficulty swallowing) 2 1 0
Dyspnea (shortness of breath) 5 4 1
Edema: limb 1 1 2
Enteritis (inflammation of the small bowel) 1 2 0
Extrapyramidal/involuntary movement/restlessness 1 0 1
Fatigue (asthenia, lethargy, malaise) 48 41 22
Fever in absence of neutropenia, ANC lt1.0x10e9/L 4 4 2
Flatulence 0 5 0
Flu-like syndrome 0 1 0
Flushing 2 0 0
Gastritis (including bile reflux gastritis) 2 1 1
Gastrointestinal-Other 2 6 1
Glucose, serum-high (hyperglycemia) 13 12 6
Hair loss/Alopecia (scalp or body) 4 3 0
Heartburn/dyspepsia 13 4 0
Hemoglobin 13 19 21
Hemolysis 1 1 0
Hemorrhage, GI - Rectum 9 6 3
Hemorrhage/Bleeding-Other 0 2 0
Hemorrhage/bleeding w/surgery, intra- or post-op 0 0 2
Hemorrhoids 0 5 1
Hepatobiliary/Pancreas-Other 1 0 0
Hiccoughs (hiccups, singultus) 2 1 2
Hot flashes/flushes 0 1 0
Hyperpigmentation 0 5 1
Hypertension 3 2 1
Hypotension 4 2 0
INR (of prothrombin time) 0 1 1
Ileus, GI (functional obstruction of bowel) 0 0 1
Incontinence, anal 1 4 0
Incontinence, urinary 1 1 0
Inf w/normal ANC or Gr 1-2 neutrophils - UTI 2 1 1
Inf w/normal ANC or Gr 1-2 neutrophils - Vagina 0 1 0
Inf w/normal ANC or Gr 1-2 neutrophils - Wound 0 0 1
Infection with unknown ANC - Abdomen NOS 0 0 2
Infection with unknown ANC - Anal/perianal 0 0 1
Infection with unknown ANC - Sinus 1 0 0
Infection with unknown ANC - Urinary tract NOS 1 0 0
Infection-Other 0 1 1
Injection site reaction/extravasation changes 1 0 0
Insomnia 4 6 1
Irregular menses (change from baseline) 0 1 0
Leak (including anastomotic), GU - Stoma 0 0 1
Leukocytes (total WBC) 2 6 3
Lipase 1 0 1
Lymphatics-Other 0 1 0
Lymphopenia 4 13 9
Magnesium, serum-high (hypermagnesemia) 2 0 0
Magnesium, serum-low (hypomagnesemia) 3 4 2
Metabolic/Laboratory-Other 3 4 2
Mood alteration - agitation 1 0 0
Mood alteration - anxiety 6 3 1
Mood alteration - depression 4 2 0
Mucositis/stomatitis (clinical exam) - Anus 0 1 0
Mucositis/stomatitis (clinical exam) - Oral cavity 14 4 0
Mucositis/stomatitis (functional/symp) - Anus 1 1 0
Mucositis/stomatitis (functional/symp) - Oral cav 9 2 0
Mucositis/stomatitis (functional/symp) - Rectum 0 4 0
Muscle weakness, not d/t neuropathy - Extrem-lower 3 2 0
Muscle weakness, not d/t neuropathy - Extrem-upper 1 0 0
Muscle weakness, not d/t neuropathy - body/general 3 4 1
Musculoskeletal/Soft Tissue-Other 0 1 0
Nail changes 2 3 1
Nasal cavity/paranasal sinus reactions 0 1 0
Nausea 37 25 7
Neurology-Other 2 0 0
Neuropathy: motor 0 1 0
Neuropathy: sensory 38 34 17
Neutrophils/granulocytes (ANC/AGC) 4 9 2
Obstruction, GI - Rectum 1 1 0
Obstruction, GI - Small bowel NOS 3 0 0
Ocular/Visual-Other 1 0 0
PTT (Partial thromboplastin time) 0 0 1
Pain - Abdomen NOS 8 19 7
Pain - Anus 0 5 1
Pain - Back 4 1 1
Pain - Bone 0 1 0
Pain - Chest/thorax NOS 1 0 0
Pain - Esophagus 0 1 0
Pain - Extremity-limb 3 4 1
Pain - Face 1 0 0
Pain - Head/headache 10 3 0
Pain - Joint 5 2 1
Pain - Kidney 1 0 0
Pain - Muscle 1 2 1
Pain - Oral cavity 2 0 0
Pain - Pelvis 1 1 1
Pain - Perineum 0 1 1
Pain - Rectum 5 20 17
Pain - Urethra 0 1 1
Pain - Vagina 0 2 0
Pain-Other 2 3 0
Phlebitis (including superficial thrombosis) 1 0 0
Phosphate, serum-low (hypophosphatemia) 1 0 0
Photosensitivity 2 1 0
Platelets 9 13 6
Pleural effusion (non-malignant) 0 1 0
Potassium, serum-high (hyperkalemia) 2 0 1
Potassium, serum-low (hypokalemia) 14 14 4
Proctitis 0 5 1
Pruritus/itching 15 5 0
Pulmonary hypertension 1 0 0
Pulmonary/Upper Respiratory-Other 0 2 0
Rash/desquamation 7 5 3
Rash: acne/acneiform 64 42 9
Rash: dermatitis associated w/Chemoradiation 0 7 1
Rash: dermatitis associated w/radiation 0 4 2
Rash: erythema multiforme 0 2 0
Rash: hand-foot skin reaction 12 12 4
Renal failure 1 0 0
Renal/Genitourinary-Other 2 0 1
Rigors/chills 3 1 2
SVT and nodal arrhythmia - Atrial fibrillation 1 0 0
SVT and nodal arrhythmia - Atrial tachycardia/PAT 0 0 1
SVT and nodal arrhythmia - Sinus tachycardia 3 0 1
Sexual/Reproductive Function-Other 1 0 0
Sodium, serum-high (hypernatremia) 2 0 0
Sodium, serum-low (hyponatremia) 7 6 6
Somnolence/depressed level of consciousness 0 2 0
Sweating (diaphoresis) 1 0 0
Syncope (fainting) 0 0 1
Taste alteration (dysgeusia) 3 4 1
Thrombosis/embolism (vascular access-related) 1 0 0
Thrombosis/thrombus/embolism 1 0 0
Tinnitus 0 1 0
Tremor 1 0 0
Urinary frequency/urgency 0 4 1
Urinary retention (including neurogenic bladder) 0 2 6
Vascular-Other 1 0 0
Ventricular arrhythmia - Ventricular tachycardia 0 1 0
Vision-blurred vision 1 0 0
Vomiting 13 5 4
Weight gain 0 1 0
Weight loss 11 15 12
Wound complication, non-infectious 0 0 2
Time Frame Up to 4 years
Adverse Event Reporting Description Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
 
Arm/Group Title Chemotherapy Chemotherapy + Radiation Tumor Resection
Hide Arm/Group Description Patients receive oxaliplatin 50 mg/m^2 IV (Days 1, 8, 15, 22, 29), cetuximab 400 mg/m^2 IV (Day 1), cetuximab 250 mg/m^2 IV (Days 8, 15, 22, 29), capecitabine 1650 mg/m^2 PO (Monday-Friday, Day 1-35). Cycle is 35 days, followed by a 14-day break. Patients receive oxaliplatin 50 mg/m^2 IV (Days 50, 57, 71, 78), cetuximab 250 mg/m^2 IV (Days 50, 57, 64, 71, 78), capecitabine 1650 mg/m^2 PO (Monday-Friday, Day 50-84). Radiation therapy begins on Day 50. Dose and length of treatment are dependent on technique used and clinical stage. Planned target value 1: 4500 cGy (centigray) in 25 fractions; Planned target value 2 (stage 3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions. Surgery must take place between 3 – 8 weeks after completion of chemoradiation. Surgical resections should adhere to the principles of total mesorectal excision as described by Heald.
All-Cause Mortality
Chemotherapy Chemotherapy + Radiation Tumor Resection
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Chemotherapy Chemotherapy + Radiation Tumor Resection
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/74 (1.35%)   0/68 (0.00%)   0/63 (0.00%) 
General disorders       
Death - Multi-organ failure  1  1/74 (1.35%)  0/68 (0.00%)  0/63 (0.00%) 
Metabolism and nutrition disorders       
Acidosis (metabolic or respiratory)  1  1/74 (1.35%)  0/68 (0.00%)  0/63 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Adult respiratory distress syndrome (ARDS)  1  1/74 (1.35%)  0/68 (0.00%)  0/63 (0.00%) 
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%
Chemotherapy Chemotherapy + Radiation Tumor Resection
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   73/74 (98.65%)   66/68 (97.06%)   51/63 (80.95%) 
Blood and lymphatic system disorders       
Hemoglobin  1  13/74 (17.57%)  19/68 (27.94%)  21/63 (33.33%) 
Gastrointestinal disorders       
Constipation  1  34/74 (45.95%)  24/68 (35.29%)  5/63 (7.94%) 
Diarrhea  1  34/74 (45.95%)  48/68 (70.59%)  10/63 (15.87%) 
Dry mouth/salivary gland (xerostomia)  1  7/74 (9.46%)  6/68 (8.82%)  0/63 (0.00%) 
Flatulence  1  0/74 (0.00%)  5/68 (7.35%)  0/63 (0.00%) 
Gastrointestinal-Other  1  2/74 (2.70%)  6/68 (8.82%)  1/63 (1.59%) 
Heartburn/dyspepsia  1  13/74 (17.57%)  4/68 (5.88%)  0/63 (0.00%) 
Hemorrhage, GI - Rectum  1  9/74 (12.16%)  6/68 (8.82%)  3/63 (4.76%) 
Hemorrhoids  1  0/74 (0.00%)  5/68 (7.35%)  1/63 (1.59%) 
Incontinence, anal  1  1/74 (1.35%)  4/68 (5.88%)  0/63 (0.00%) 
Mucositis/stomatitis (clinical exam) - Oral cavity  1  14/74 (18.92%)  4/68 (5.88%)  0/63 (0.00%) 
Mucositis/stomatitis (functional/symp) - Oral cav  1  9/74 (12.16%)  2/68 (2.94%)  0/63 (0.00%) 
Mucositis/stomatitis (functional/symp) - Rectum  1  0/74 (0.00%)  4/68 (5.88%)  0/63 (0.00%) 
Nausea  1  37/74 (50.00%)  25/68 (36.76%)  7/63 (11.11%) 
Pain - Abdomen NOS  1  8/74 (10.81%)  19/68 (27.94%)  7/63 (11.11%) 
Pain - Anus  1  0/74 (0.00%)  5/68 (7.35%)  1/63 (1.59%) 
Pain - Rectum  1  5/74 (6.76%)  20/68 (29.41%)  17/63 (26.98%) 
Proctitis  1  0/74 (0.00%)  5/68 (7.35%)  1/63 (1.59%) 
Vomiting  1  13/74 (17.57%)  5/68 (7.35%)  4/63 (6.35%) 
General disorders       
Fatigue (asthenia, lethargy, malaise)  1  48/74 (64.86%)  41/68 (60.29%)  22/63 (34.92%) 
Fever in absence of neutropenia, ANC lt1.0x10e9/L  1  4/74 (5.41%)  4/68 (5.88%)  2/63 (3.17%) 
Injury, poisoning and procedural complications       
Rash: dermatitis associated w/Chemoradiation  1  0/74 (0.00%)  7/68 (10.29%)  1/63 (1.59%) 
Rash: dermatitis associated w/radiation  1  0/74 (0.00%)  4/68 (5.88%)  2/63 (3.17%) 
Investigations       
ALT, SGPT (serum glutamic pyruvic transaminase)  1  15/74 (20.27%)  11/68 (16.18%)  3/63 (4.76%) 
AST, SGOT  1  15/74 (20.27%)  12/68 (17.65%)  2/63 (3.17%) 
Alkaline phosphatase  1  4/74 (5.41%)  5/68 (7.35%)  3/63 (4.76%) 
Bilirubin (hyperbilirubinemia)  1  5/74 (6.76%)  3/68 (4.41%)  2/63 (3.17%) 
Creatinine  1  2/74 (2.70%)  0/68 (0.00%)  4/63 (6.35%) 
Leukocytes (total WBC)  1  2/74 (2.70%)  6/68 (8.82%)  3/63 (4.76%) 
Lymphopenia  1  4/74 (5.41%)  13/68 (19.12%)  9/63 (14.29%) 
Metabolic/Laboratory-Other  1  3/74 (4.05%)  4/68 (5.88%)  2/63 (3.17%) 
Neutrophils/granulocytes (ANC/AGC)  1  4/74 (5.41%)  9/68 (13.24%)  2/63 (3.17%) 
Platelets  1  9/74 (12.16%)  13/68 (19.12%)  6/63 (9.52%) 
Weight loss  1  11/74 (14.86%)  15/68 (22.06%)  12/63 (19.05%) 
Metabolism and nutrition disorders       
Albumin, serum-low (hypoalbuminemia)  1  11/74 (14.86%)  10/68 (14.71%)  7/63 (11.11%) 
Anorexia  1  20/74 (27.03%)  18/68 (26.47%)  9/63 (14.29%) 
Calcium, serum-low (hypocalcemia)  1  8/74 (10.81%)  13/68 (19.12%)  9/63 (14.29%) 
Dehydration  1  8/74 (10.81%)  11/68 (16.18%)  1/63 (1.59%) 
Glucose, serum-high (hyperglycemia)  1  13/74 (17.57%)  12/68 (17.65%)  6/63 (9.52%) 
Magnesium, serum-low (hypomagnesemia)  1  3/74 (4.05%)  4/68 (5.88%)  2/63 (3.17%) 
Potassium, serum-low (hypokalemia)  1  14/74 (18.92%)  14/68 (20.59%)  4/63 (6.35%) 
Sodium, serum-low (hyponatremia)  1  7/74 (9.46%)  6/68 (8.82%)  6/63 (9.52%) 
Musculoskeletal and connective tissue disorders       
Muscle weakness, not d/t neuropathy - body/general  1  3/74 (4.05%)  4/68 (5.88%)  1/63 (1.59%) 
Pain - Back  1  4/74 (5.41%)  1/68 (1.47%)  1/63 (1.59%) 
Pain - Extremity-limb  1  3/74 (4.05%)  4/68 (5.88%)  1/63 (1.59%) 
Pain - Joint  1  5/74 (6.76%)  2/68 (2.94%)  1/63 (1.59%) 
Nervous system disorders       
Dizziness  1  10/74 (13.51%)  7/68 (10.29%)  1/63 (1.59%) 
Neuropathy: sensory  1  38/74 (51.35%)  34/68 (50.00%)  17/63 (26.98%) 
Pain - Head/headache  1  10/74 (13.51%)  3/68 (4.41%)  0/63 (0.00%) 
Taste alteration (dysgeusia)  1  3/74 (4.05%)  4/68 (5.88%)  1/63 (1.59%) 
Psychiatric disorders       
Insomnia  1  4/74 (5.41%)  6/68 (8.82%)  1/63 (1.59%) 
Mood alteration - anxiety  1  6/74 (8.11%)  3/68 (4.41%)  1/63 (1.59%) 
Mood alteration - depression  1  4/74 (5.41%)  2/68 (2.94%)  0/63 (0.00%) 
Renal and urinary disorders       
Urinary frequency/urgency  1  0/74 (0.00%)  4/68 (5.88%)  1/63 (1.59%) 
Urinary retention (including neurogenic bladder)  1  0/74 (0.00%)  2/68 (2.94%)  6/63 (9.52%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  2/74 (2.70%)  6/68 (8.82%)  1/63 (1.59%) 
Dyspnea (shortness of breath)  1  5/74 (6.76%)  4/68 (5.88%)  1/63 (1.59%) 
Skin and subcutaneous tissue disorders       
Dry skin  1  20/74 (27.03%)  16/68 (23.53%)  2/63 (3.17%) 
Hair loss/Alopecia (scalp or body)  1  4/74 (5.41%)  3/68 (4.41%)  0/63 (0.00%) 
Hyperpigmentation  1  0/74 (0.00%)  5/68 (7.35%)  1/63 (1.59%) 
Pruritus/itching  1  15/74 (20.27%)  5/68 (7.35%)  0/63 (0.00%) 
Rash/desquamation  1  7/74 (9.46%)  5/68 (7.35%)  3/63 (4.76%) 
Rash: acne/acneiform  1  64/74 (86.49%)  42/68 (61.76%)  9/63 (14.29%) 
Rash: hand-foot skin reaction  1  12/74 (16.22%)  12/68 (17.65%)  4/63 (6.35%) 
Vascular disorders       
Hypotension  1  4/74 (5.41%)  2/68 (2.94%)  0/63 (0.00%) 
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: SWOG Statistician
Organization: SWOG Statistical Center
Phone: 206-667-4408
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00686166     History of Changes
Other Study ID Numbers: S0713
S0713 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: May 28, 2008
First Posted: May 29, 2008
Results First Submitted: January 26, 2016
Results First Posted: February 24, 2016
Last Update Posted: May 18, 2018