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Trial record 55 of 439 for:    colon cancer AND Capecitabine

Cetuximab and Capecitabine in Treating Patients With Metastatic Colorectal Cancer That Failed Irinotecan Treatment

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ClinicalTrials.gov Identifier: NCT00538291
Recruitment Status : Terminated (Study was terminated early due to lack of efficacy.)
First Posted : October 2, 2007
Results First Posted : August 28, 2014
Last Update Posted : August 28, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

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
Genetic: gene expression analysis
Genetic: microarray analysis
Genetic: polymorphism analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: immunohistochemistry staining method
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1
Hide Arm/Group Description Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
Period Title: Overall Study
Started 13
Completed 10
Not Completed 3
Reason Not Completed
Adverse Event             2
Withdrawal by Subject             1
Arm/Group Title Arm 1
Hide Arm/Group Description Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants
61
(23 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
6
  46.2%
Male
7
  53.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
1.Primary Outcome
Title Response Rate
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by spiral CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame Assessment after every 2 cycles of treatment, up to 1 year.
Hide Outcome Measure Data
Hide Analysis Population Description
The three patients not completing at least two courses of treatment were considered treatment failures and were included in efficacy analysis.
Arm/Group Title Arm 1
Hide Arm/Group Description:
Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: number of responding participants
1
Time Frame Adverse events occurred over a period of of 17 months.
Adverse Event Reporting Description "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
 
Arm/Group Title Arm 1
Hide Arm/Group Description Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
All-Cause Mortality
Arm 1
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1
Affected / at Risk (%) # Events
Total   4/13 (30.77%)    
Gastrointestinal disorders   
Diarrhea * 1  2/13 (15.38%)  2
Mucositis oral * 1  1/13 (7.69%)  1
Nausea * 1  1/13 (7.69%)  1
Vomiting * 1  1/13 (7.69%)  1
General disorders   
Death * 1  1/13 (7.69%)  1
Infections and infestations   
Penile infection * 1  1/13 (7.69%)  1
Investigations   
Leukocyte count decreased * 1  1/13 (7.69%)  1
Metabolism and nutrition disorders   
Anorexia * 1  1/13 (7.69%)  1
Dehydration * 1  2/13 (15.38%)  2
Serum phosphate decreased * 1  1/13 (7.69%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, meddra10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1
Affected / at Risk (%) # Events
Total   13/13 (100.00%)    
Blood and lymphatic system disorders   
Hemoglobin decreased * 1  9/13 (69.23%)  23
Cardiac disorders   
Sinus tachycardia * 1  2/13 (15.38%)  2
Gastrointestinal disorders   
Abdominal distension * 2  1/13 (7.69%)  4
Abdominal pain * 2  2/13 (15.38%)  3
Constipation * 2  1/13 (7.69%)  1
Diarrhea * 1  3/13 (23.08%)  5
Dyspepsia * 1  1/13 (7.69%)  1
Dysphagia * 1  1/13 (7.69%)  1
Ear, nose and throat examination abnormal * 2  3/13 (23.08%)  3
Enteritis * 1  1/13 (7.69%)  1
Nausea * 1  2/13 (15.38%)  2
Rectal pain * 1  1/13 (7.69%)  1
Vomiting * 1  2/13 (15.38%)  2
General disorders   
Chest pain * 1  1/13 (7.69%)  1
Chills * 1  1/13 (7.69%)  1
Edema limbs * 2  4/13 (30.77%)  5
Fatigue * 1  12/13 (92.31%)  42
Fever * 1  3/13 (23.08%)  3
Injection site reaction * 1  1/13 (7.69%)  1
Infections and infestations   
Conjunctivitis infective * 1  1/13 (7.69%)  1
Upper respiratory infection * 1  1/13 (7.69%)  1
Vaginal infection * 1  1/13 (7.69%)  1
Injury, poisoning and procedural complications   
Vascular access complication * 1  1/13 (7.69%)  1
Investigations   
Activated partial thromboplastin time prolonged * 1  1/13 (7.69%)  1
Alanine aminotransferase increased * 1  8/13 (61.54%)  20
Alkaline phosphatase increased * 1  9/13 (69.23%)  20
Aspartate aminotransferase increased * 1  11/13 (84.62%)  37
Bilirubin increased * 1  3/13 (23.08%)  3
Creatinine increased * 1  2/13 (15.38%)  2
Hyperbilirubinemia * 2  2/13 (15.38%)  5
Leukocyte count decreased * 1  5/13 (38.46%)  8
Leukopenia * 2  1/13 (7.69%)  2
Lipase increased * 1  1/13 (7.69%)  1
Lymphocyte count decreased * 1  1/13 (7.69%)  2
Lymphopenia * 2  3/13 (23.08%)  5
Neutrophil count decreased * 1  2/13 (15.38%)  3
Platelet count decreased * 1  3/13 (23.08%)  16
Weight loss * 1  3/13 (23.08%)  3
Metabolism and nutrition disorders   
Anorexia * 1  3/13 (23.08%)  3
Blood bicarbonate decreased * 1  1/13 (7.69%)  1
Blood glucose increased * 1  2/13 (15.38%)  3
Hypercalcemia * 2  1/13 (7.69%)  1
Hyperglycemia * 2  3/13 (23.08%)  7
Hypoalbuminemia * 2  4/13 (30.77%)  13
Hypocalcemia * 2  4/13 (30.77%)  11
Hypokalemia * 2  1/13 (7.69%)  6
Hypomagnesemia * 2  1/13 (7.69%)  2
Hyponatremia * 2  2/13 (15.38%)  4
Hypophosphatemia * 2  3/13 (23.08%)  6
Serum albumin decreased * 1  4/13 (30.77%)  7
Serum calcium decreased * 1  3/13 (23.08%)  6
Serum calcium increased * 1  1/13 (7.69%)  1
Serum glucose decreased * 1  1/13 (7.69%)  1
Serum magnesium decreased * 1  4/13 (30.77%)  11
Serum magnesium increased * 1  2/13 (15.38%)  2
Serum phosphate decreased * 1  3/13 (23.08%)  4
Serum potassium decreased * 1  4/13 (30.77%)  9
Serum potassium increased * 1  1/13 (7.69%)  1
Serum sodium decreased * 1  2/13 (15.38%)  2
Musculoskeletal and connective tissue disorders   
Back pain * 1  3/13 (23.08%)  7
Chest wall pain * 1  2/13 (15.38%)  7
Muscle weakness * 1  1/13 (7.69%)  1
Myalgia * 1  1/13 (7.69%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor pain * 1  1/13 (7.69%)  1
Nervous system disorders   
Dizziness * 1  1/13 (7.69%)  1
Peripheral sensory neuropathy * 1  3/13 (23.08%)  7
Psychiatric disorders   
Confusion * 1  2/13 (15.38%)  2
Depression * 1  1/13 (7.69%)  1
Insomnia * 1  1/13 (7.69%)  2
Renal and urinary disorders   
Bladder pain * 1  1/13 (7.69%)  1
Protein urine positive * 1  1/13 (7.69%)  1
Ureteric hemorrhage * 1  2/13 (15.38%)  3
Urethral pain * 1  1/13 (7.69%)  1
Urinary frequency * 1  1/13 (7.69%)  2
Urine discoloration * 1  1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  4/13 (30.77%)  7
Pharyngolaryngeal pain * 1  1/13 (7.69%)  1
Voice alteration * 1  1/13 (7.69%)  1
Skin and subcutaneous tissue disorders   
Acne * 2  4/13 (30.77%)  13
Dry skin * 1  1/13 (7.69%)  2
Hand-and-foot syndrome * 1  8/13 (61.54%)  15
Nail disorder * 1  1/13 (7.69%)  2
Pruritus * 2  1/13 (7.69%)  1
Rash acneiform * 1  7/13 (53.85%)  16
Rash desquamating * 1  4/13 (30.77%)  6
Skin disorder * 1  1/13 (7.69%)  1
Skin hyperpigmentation * 1  1/13 (7.69%)  2
Skin ulceration * 1  1/13 (7.69%)  1
Vascular disorders   
Flushing * 1  1/13 (7.69%)  2
Hypotension * 1  1/13 (7.69%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, meddra10.0
2
Term from vocabulary, meddra9.0
Study was terminated due to a lack of efficacy (less than 2 of 13 patients responded to treatment in the first stage of a Simon's two stage design).
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Paul Frankel, Ph.D.
Organization: City of Hope National Medical Center
Phone: (626)359-8111 ext 65265
EMail: pfrankel@coh.org
Layout table for additonal information
Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00538291     History of Changes
Other Study ID Numbers: 05033
P30CA033572 ( U.S. NIH Grant/Contract )
CHNMC-05033
CDR0000567432 ( Registry Identifier: NCI PDQ )
First Submitted: October 1, 2007
First Posted: October 2, 2007
Results First Submitted: June 12, 2014
Results First Posted: August 28, 2014
Last Update Posted: August 28, 2014