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Docetaxel+Oxali+/-Cetux Met Gastric/GEJ

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ClinicalTrials.gov Identifier: NCT00517829
Recruitment Status : Completed
First Posted : August 17, 2007
Results First Posted : February 11, 2016
Last Update Posted : November 28, 2016
Sponsor:
Collaborators:
Eli Lilly and Company
Sanofi
Information provided by (Responsible Party):
US Oncology Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gastric Cancer Adenocarcinoma Metastatic
Interventions Drug: Docetaxel
Drug: cetuximab
Drug: oxaliplatin
Enrollment 150
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DOCOX DOCOX+Cebuximab
Hide Arm/Group Description Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
Period Title: Overall Study
Started 75 75
Completed 0 0
Not Completed 75 75
Reason Not Completed
Adverse Event             22             34
Disease Progression             39             32
Patient Request             6             5
Investigator Request             5             3
Other             3             1
Arm/Group Title DOCOX DOCOX+Cebuximab Total
Hide Arm/Group Description Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days Total of all reporting groups
Overall Number of Baseline Participants 75 75 150
Hide Baseline Analysis Population Description
ITT population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 75 participants 150 participants
60.5  (10.9) 61.5  (11.5) 61.0  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
Female
16
  21.3%
15
  20.0%
31
  20.7%
Male
59
  78.7%
60
  80.0%
119
  79.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
Caucasian 62 56 118
Black 5 7 12
Hispanic 5 9 14
Asian 3 1 4
Hawaiian 0 1 1
Other 0 1 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 75 participants 75 participants 150 participants
75 75 150
1.Primary Outcome
Title Progression-free Survival
Hide Description

PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Time Frame Treatment will continue until disease progression or intolerable toxicity, up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title DOCOX DOCOX+Cebuximab
Hide Arm/Group Description:
Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
Overall Number of Participants Analyzed 75 75
Median (95% Confidence Interval)
Unit of Measure: months
4.7
(3.0 to 5.6)
5.1
(4.3 to 5.9)
2.Secondary Outcome
Title Overall Survival
Hide Description OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
Time Frame Treatment will continue until disease progression or intolerable toxicity
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title DOCOX DOCOX+Cebuximab
Hide Arm/Group Description:
Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
Overall Number of Participants Analyzed 75 75
Median (95% Confidence Interval)
Unit of Measure: months
8.5
(7.1 to 12.0)
9.4
(6.7 to 10.1)
3.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
Time Frame Treatment will continue until disease progression or intolerable toxicity.
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population
Arm/Group Title DOCOX DOCOX+Cebuximab
Hide Arm/Group Description:
Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
Overall Number of Participants Analyzed 68 71
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
26.5
(16.5 to 38.6)
38.0
(26.8 to 50.3)
4.Secondary Outcome
Title Time to Response
Hide Description For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.
Time Frame Treatment will continue until disease progression or intolerable toxicity
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who achieve a major objective response (CR or PR)
Arm/Group Title DOCOX DOCOX+Cebuximab
Hide Arm/Group Description:
Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
Overall Number of Participants Analyzed 18 27
Median (95% Confidence Interval)
Unit of Measure: months
1.3
(1.1 to 5.2)
1.4
(1.1 to 4.0)
5.Secondary Outcome
Title Duration of Response
Hide Description The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.
Time Frame Treatment will continue until disease progression or intolerable toxicity
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who achieve a major objective response (CR or PR).
Arm/Group Title DOCOX DOCOX+Cebuximab
Hide Arm/Group Description:
Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
Overall Number of Participants Analyzed 18 27
Median (95% Confidence Interval)
Unit of Measure: months
7.3
(1.5 to 23.7)
5.6
(2.3 to 13.2)
Time Frame During the whole treatment period, up to 30 days following last dose.
Adverse Event Reporting Description For treated patients only, assessed at each treatment visit.
 
Arm/Group Title DOCOX DOCOX+Cebuximab
Hide Arm/Group Description Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
All-Cause Mortality
DOCOX DOCOX+Cebuximab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
DOCOX DOCOX+Cebuximab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/68 (29.41%)      26/72 (36.11%)    
Blood and lymphatic system disorders     
ANEMIA  1  3/68 (4.41%)  3 1/72 (1.39%)  1
LEUKOPENIA  1  1/68 (1.47%)  1 0/72 (0.00%)  0
NEUTROPENIA  1  1/68 (1.47%)  1 2/72 (2.78%)  2
Cardiac disorders     
FIBRILLATION ATRIAL  1  0/68 (0.00%)  0 1/72 (1.39%)  1
Gastrointestinal disorders     
ABDOMINAL PAIN  1  2/68 (2.94%)  2 0/72 (0.00%)  0
CHOLANGITIS  1  1/68 (1.47%)  1 0/72 (0.00%)  0
COLITIS  1  1/68 (1.47%)  1 2/72 (2.78%)  3
DEHYDRATION  1  4/68 (5.88%)  4 3/72 (4.17%)  3
DIARRHEA  1  5/68 (7.35%)  5 4/72 (5.56%)  6
ESOPHAGEAL DISORDER  1  1/68 (1.47%)  1 0/72 (0.00%)  0
GASTRIC ULCER PERFORATED  1  0/68 (0.00%)  0 1/72 (1.39%)  1
GASTROINTESTINAL BLEEDING  1  2/68 (2.94%)  2 0/72 (0.00%)  0
NAUSEA  1  1/68 (1.47%)  1 0/72 (0.00%)  0
PERFORATION GASTROINTESTINAL  1  0/68 (0.00%)  0 1/72 (1.39%)  1
STOMATITIS  1  0/68 (0.00%)  0 1/72 (1.39%)  1
VOMITING  1  1/68 (1.47%)  1 0/72 (0.00%)  0
General disorders     
CHEST PAIN  1  0/68 (0.00%)  0 1/72 (1.39%)  1
CHILLS  1  0/68 (0.00%)  0 1/72 (1.39%)  1
FATIGUE  1  1/68 (1.47%)  1 1/72 (1.39%)  1
FEVER  1  1/68 (1.47%)  1 1/72 (1.39%)  1
SWEATING  1  0/68 (0.00%)  0 1/72 (1.39%)  1
WEAKNESS GENERALIZED  1  0/68 (0.00%)  0 1/72 (1.39%)  1
Immune system disorders     
ALLERGIC REACTION  1  1/68 (1.47%)  1 2/72 (2.78%)  2
Infections and infestations     
FEBRILE NEUTROPENIA  1  7/68 (10.29%)  7 13/72 (18.06%)  14
INFECTION  1  2/68 (2.94%)  3 1/72 (1.39%)  1
SEPSIS  1  1/68 (1.47%)  1 0/72 (0.00%)  0
Investigations     
CACHEXIA  1  0/68 (0.00%)  0 1/72 (1.39%)  1
CANCER  1  0/68 (0.00%)  0 1/72 (1.39%)  1
Metabolism and nutrition disorders     
DEFICIENCY VITAMIN  1  0/68 (0.00%)  0 1/72 (1.39%)  1
HYPONATREMIA  1  0/68 (0.00%)  0 1/72 (1.39%)  1
HYPOPHOSPHATEMIA  1  0/68 (0.00%)  0 1/72 (1.39%)  1
HYPOXEMIA  1  1/68 (1.47%)  1 0/72 (0.00%)  0
IMBALANCE BLOOD ELECTROLYTE  1  0/68 (0.00%)  0 1/72 (1.39%)  1
Musculoskeletal and connective tissue disorders     
MUSCLE WEAKNESS  1  0/68 (0.00%)  0 1/72 (1.39%)  1
Nervous system disorders     
HYPERSENSITIVITY REACTION (NOS)  1  0/68 (0.00%)  0 1/72 (1.39%)  1
NEUROPATHY  1  0/68 (0.00%)  0 2/72 (2.78%)  2
SHOCK  1  1/68 (1.47%)  1 1/72 (1.39%)  1
SYNCOPE  1  1/68 (1.47%)  1 1/72 (1.39%)  2
Renal and urinary disorders     
INFECTION BLADDER  1  0/68 (0.00%)  0 1/72 (1.39%)  1
RENAL FAILURE  1  0/68 (0.00%)  0 1/72 (1.39%)  1
Reproductive system and breast disorders     
EDEMA SCROTAL  1  0/68 (0.00%)  0 1/72 (1.39%)  1
Respiratory, thoracic and mediastinal disorders     
BRONCHOSPASM  1  1/68 (1.47%)  1 0/72 (0.00%)  0
EDEMA LARYNX  1  0/68 (0.00%)  0 1/72 (1.39%)  1
LUNG FIBROSIS INTERSTITIAL  1  1/68 (1.47%)  1 0/72 (0.00%)  0
PNEUMONIA  1  1/68 (1.47%)  1 0/72 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART, CTCAE v3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DOCOX DOCOX+Cebuximab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   65/68 (95.59%)      67/72 (93.06%)    
Blood and lymphatic system disorders     
ANEMIA  1  19/68 (27.94%)  43 19/72 (26.39%)  31
LEUKOPENIA  1  13/68 (19.12%)  26 14/72 (19.44%)  47
NEUTROPENIA  1  45/68 (66.18%)  141 41/72 (56.94%)  119
THROMBOCYTOPENIA  1  12/68 (17.65%)  41 8/72 (11.11%)  23
Gastrointestinal disorders     
ABDOMINAL PAIN  1  1/68 (1.47%)  1 5/72 (6.94%)  6
ANOREXIA  1  13/68 (19.12%)  28 12/72 (16.67%)  16
CONSTIPATION  1  10/68 (14.71%)  11 13/72 (18.06%)  19
DEHYDRATION  1  9/68 (13.24%)  13 11/72 (15.28%)  20
DIARRHEA  1  26/68 (38.24%)  39 34/72 (47.22%)  92
FEVER  1  5/68 (7.35%)  6 2/72 (2.78%)  4
MUCOSITIS ORAL  1  3/68 (4.41%)  4 8/72 (11.11%)  11
NAUSEA  1  26/68 (38.24%)  37 27/72 (37.50%)  53
PAIN MOUTH  1  1/68 (1.47%)  1 4/72 (5.56%)  4
STOMATITIS  1  0/68 (0.00%)  0 8/72 (11.11%)  13
TASTE ALTERATION  1  10/68 (14.71%)  13 8/72 (11.11%)  10
VOMITING  1  14/68 (20.59%)  18 12/72 (16.67%)  20
General disorders     
FATIGUE  1  33/68 (48.53%)  75 36/72 (50.00%)  81
HEADACHE  1  4/68 (5.88%)  4 4/72 (5.56%)  4
INSOMNIA  1  1/68 (1.47%)  1 4/72 (5.56%)  7
PAIN  1  3/68 (4.41%)  3 7/72 (9.72%)  8
WEAKNESS GENERALIZED  1  8/68 (11.76%)  11 6/72 (8.33%)  7
Immune system disorders     
ALLERGIC REACTION  1  1/68 (1.47%)  1 6/72 (8.33%)  6
Metabolism and nutrition disorders     
HYPERGLYCEMIA  1  2/68 (2.94%)  6 5/72 (6.94%)  12
HYPOCALCEMIA  1  1/68 (1.47%)  4 4/72 (5.56%)  10
HYPOKALEMIA  1  5/68 (7.35%)  5 5/72 (6.94%)  10
HYPOMAGNESEMIA  1  4/68 (5.88%)  4 14/72 (19.44%)  39
Musculoskeletal and connective tissue disorders     
MUSCLE WEAKNESS  1  0/68 (0.00%)  0 7/72 (9.72%)  8
Nervous system disorders     
DIZZINESS  1  1/68 (1.47%)  1 6/72 (8.33%)  6
HYPERSENSITIVITY REACTION (NOS)  1  3/68 (4.41%)  3 9/72 (12.50%)  12
NEUROPATHY  1  17/68 (25.00%)  23 9/72 (12.50%)  14
NEUROPATHY PERIPHERAL  1  12/68 (17.65%)  18 16/72 (22.22%)  34
TINGLING  1  4/68 (5.88%)  11 4/72 (5.56%)  4
Skin and subcutaneous tissue disorders     
ALOPECIA  1  22/68 (32.35%)  24 17/72 (23.61%)  19
DRY SKIN  1  1/68 (1.47%)  1 9/72 (12.50%)  10
FLUSHING  1  4/68 (5.88%)  4 2/72 (2.78%)  2
IRRITATION SKIN  1  0/68 (0.00%)  0 4/72 (5.56%)  4
RASH  1  2/68 (2.94%)  3 17/72 (23.61%)  36
RASH ACNEFORM  1  0/68 (0.00%)  0 32/72 (44.44%)  58
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART, CTCAE v3.0
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
Layout table for Results Point of Contact information
Name/Title: Dr. Donald Richards
Organization: Texas Oncology, Tyler Cancer Center
Phone: 903-579-9800
EMail: donald.richards@usoncology.com
Layout table for additonal information
Responsible Party: US Oncology Research
ClinicalTrials.gov Identifier: NCT00517829     History of Changes
Other Study ID Numbers: 06063
First Submitted: August 15, 2007
First Posted: August 17, 2007
Results First Submitted: January 12, 2016
Results First Posted: February 11, 2016
Last Update Posted: November 28, 2016