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Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis

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: NCT00033371
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : February 4, 2015
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Colorectal Cancer
Familial Adenomatous Polyposis
Interventions Drug: Celecoxib
Other: Placebo
Drug: eflornithine
Other: Laboratory biomarker analysis
Other: Questionnaire administration
Enrollment 205
Recruitment Details Recruitment Period: December 13, 2001 to October 21, 2008. All recruitment done in medical clinics, with the trial conducted at the University of Texas MD Anderson Cancer, the Cleveland Clinic in Cleveland and St. Mark's Hospital in Harrow, UK.
Pre-assignment Details Of the 205 participants with familial adenomatous polyposis (FAP) recruited, 112 were randomized. The study was closed due to slow recruitment with enrollment target almost met.
Arm/Group Title Arm I: Celecoxib and Placebo Arm II: Celecoxib and Eflornithine
Hide Arm/Group Description Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days). Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
Period Title: Overall Study
Started 55 57
Completed 49 47
Not Completed 6 10
Reason Not Completed
Adverse Event             1             5
Lost to Follow-up             2             1
Withdrawal by Subject             3             3
Disease Progression             0             1
Arm/Group Title Arm I: Celecoxib and Placebo Arm II: Celecoxib and Eflornithine Total
Hide Arm/Group Description Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days). Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days). Total of all reporting groups
Overall Number of Baseline Participants 55 57 112
Hide Baseline Analysis Population Description
According to the protocol, a patient needed to receive at least 80% of intended overall dose AND at least 80% dose during the final 60 days of the study to qualify as evaluable. One participant was randomized to Arm II but withdrew prior to receiving any treatment.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 55 participants 57 participants 112 participants
38
(18 to 63)
38
(19 to 59)
38
(18 to 63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 57 participants 112 participants
Female
25
  45.5%
27
  47.4%
52
  46.4%
Male
30
  54.5%
30
  52.6%
60
  53.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 57 participants 112 participants
Hispanic or Latino
7
  12.7%
4
   7.0%
11
   9.8%
Not Hispanic or Latino
46
  83.6%
50
  87.7%
96
  85.7%
Unknown or Not Reported
2
   3.6%
3
   5.3%
5
   4.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 57 participants 112 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   1.8%
1
   0.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   1.8%
1
   0.9%
White
53
  96.4%
53
  93.0%
106
  94.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   3.6%
2
   3.5%
4
   3.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 55 participants 57 participants 112 participants
United States 42 43 85
United Kingdom 13 14 27
Basis of FAP Diagnosis   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 55 participants 57 participants 112 participants
>100 Polyps 21 23 44
>10 Polyps and age <40 28 23 51
>25 Polyps and age >40 6 11 17
[1]
Measure Description: Eligible participants aged 18-65 years required to have clinical diagnosis of FAP based on personal history of one of following a)>100 adenomas; b)>10 adenomas before age 40 years; c)>25 adenomas and, if age>40 years, a characteristic family history (autosomal dominant pattern) including >100 polyps in first degree family member, >25 polyps in 2 relatives in two generations, genetic diagnosis in a relative, or d) genetic diagnosis by sequencing/similar assay. Participants required to have an evaluable colon and/or rectal segment, and 5 or more colorectal polyps' ≥2mm at baseline examination.
Colon versus Rectum   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 55 participants 57 participants 112 participants
Colon 19 27 46
Rectum Only 36 30 66
[1]
Measure Description: Number of participants with intact colon (Colon); or those with rectum only (Rectum Only).
Number of Landmark Polyps at Baseline Screen  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 55 participants 57 participants 112 participants
0-1 3 5 8
2-4 7 12 19
5-9 19 21 40
10 or more 22 19 41
No Baseline Screen 4 0 4
Number of Landmark Polyps at least 2 mm at Baseline Screen  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 55 participants 57 participants 112 participants
0-1 13 20 33
2-4 12 23 35
5-9 22 8 30
10 or more 4 6 10
No Baseline Screen 4 0 4
Number Landmark Polyps at least 2 mm at Baseline Screen for Evaluable polyps, Evaluable Participants  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 55 participants 57 participants 112 participants
0-1 9 13 22
2-4 11 13 24
5-9 13 5 18
10 or more 0 4 4
No Baseline Screen 4 0 4
Not Evaulable Participant 18 22 40
1.Primary Outcome
Title Percent Change in the Number of Polyps Greater Than or Equal to 2mm in Diameter in Focal Area(s) of the Colorectum
Hide Description Differences between average treatment effects of two study arms tested using two-sided type I error rate of 5% in two-sample t-test. If model assumptions not met by data or transformations of data, appropriate nonparametric tests (e.g. Wilcoxon rank sums test) were used to compare treatment arms - Percent change of polyp counts from baseline to 6 months, ie [(6 months - baseline) x 100]/baseline (%). For each participant, first were matched polyps between baseline & 6 months by region and landmark and summed over all matched regions on number of polyps >2 mm to calculate total number of polyps >2 mm at baseline & 6 months, respectively. For participants refusing exit colonoscopy, 0% change entered as primary endpoint. Defined ITT All: All patients; if 6-month polyp counts missing = 0% change; ITT Measurable: All participants with baseline & 6 month polyp counts; ITT Evaluable: ITT Measurable participants who also took 80% of treatment, both overall as well as during final 60 days.
Time Frame Baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
112 patients were randomized to the study. Analysis was by intent to treat (ITT) with a total of 89 ITT participants measurable by having complete polyp information.
Arm/Group Title Arm I: Celecoxib and Placebo Arm II: Celecoxib and Eflornithine
Hide Arm/Group Description:
Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).
Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
Overall Number of Participants Analyzed 55 57
Mean (Standard Error)
Unit of Measure: percentage change in polyp count
ITT All -1  (0.11) -11  (0.08)
ITT Measurable -1  (0.14) -13  (0.10)
ITT Evaluable 10  (0.18) -8  (0.12)
2.Primary Outcome
Title Number of Participants With Adverse Events Occurring at a Frequency of 5% or Grade 3 and Higher
Hide Description To determine the relative tolerability and safety of celecoxib + DFMO in FAP study participants. Includes only adverse events that occurred in at least 5% of the patients or a patient exhibited at least 1 grade 3 toxicity.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Total of 57 participants in Arm II, 1 participant is missing AE data
Arm/Group Title Arm I:Celecoxib, 400 mg p.o. BID Plus DFMO Placebo ( 60 Partic Arm II: Celecoxib, 400 mg p.o. BID Plus DFMO 0.5 gm/m2/Day Rou
Hide Arm/Group Description:
Celecoxib, 400 mg p.o. BID plus DFMO placebo ( 60 participants with evaluable colon or rectum)
Celecoxib, 400 mg p.o. BID plus DFMO 0.5 gm/m2/day rounded down to the nearest 250mg dose ( 60 participants with evaluable colon or rectum). "
Overall Number of Participants Analyzed 55 56
Measure Type: Count of Participants
Unit of Measure: Participants
High-frequency hearing loss
4
   7.3%
7
  12.5%
Fatigue
11
  20.0%
3
   5.4%
Diarrhoea
6
  10.9%
4
   7.1%
Heartburn/dyspepsia
4
   7.3%
2
   3.6%
Mucositis/stomatitis
11
  20.0%
15
  26.8%
Nausea/vomiting
6
  10.9%
7
  12.5%
Gout
0
   0.0%
1
   1.8%
Headache
5
   9.1%
1
   1.8%
3.Secondary Outcome
Title Percentage Change in Global Colorectal Polyps Burden
Hide Description Percentage Change in Global Colorectal Polyps burden
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 89 participants had complete polyp information at baseline and 6 months.
Arm/Group Title Arm I: Celecoxib and Placebo Arm II: Celecoxib and Eflornithine
Hide Arm/Group Description:
Celecoxib, 400 mg p.o. BID plus DFMO placebo ( 60 participants with evaluable colon or rectum)
Celecoxib, 400 mg p.o. BID plus DFMO 0.5 gm/m2/day rounded down to the nearest 250mg dose ( 60 participants with evaluable colon or rectum).
Overall Number of Participants Analyzed 44 45
Mean (Standard Error)
Unit of Measure: percentage change of total Polyps burden
-27  (6) -40  (6)
4.Secondary Outcome
Title Percent Change in the Area of Plaque-like Duodenal Polyps
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The data was inevaluable to determine the percent change in the area of plaque-like duodenal polyps
Arm/Group Title Arm I: Celecoxib and Placebo Arm II: Celecoxib and Eflornithine
Hide Arm/Group Description:
Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).
Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Other Pre-specified Outcome
Title Global Duodenal Polyp Burden
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The data was inevaluable to determine the global duodenal polyp burden
Arm/Group Title Arm I: Celecoxib and Placebo Arm II: Celecoxib and Eflornithine
Hide Arm/Group Description:
Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).
Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Other Pre-specified Outcome
Title Percent Change in Polyp Size in Focal Area(s) of the Colorectum
Hide Description [Not Specified]
Time Frame Baseline up to 2 months after completion of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
No data collected to determine the percentage change in polyp size in focal area(s) of the colorectum.
Arm/Group Title Arm I: Celecoxib and Placebo Arm II: Celecoxib and Eflornithine
Hide Arm/Group Description:
Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).
Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event (AE) collection was done monthly up to month 6 or early termination with all collected adverse events for randomized participants reported.
Adverse Event Reporting Description Each adverse event (toxicity) reported counts once per participant. For example, if a participant had Grade 2 vomiting that increased to Grade 3 and then reduced to Grade 1 before going away, it counts as one event of Grade 3 vomiting.
 
Arm/Group Title Arm I: Celecoxib and Placebo Arm II: Celecoxib and Eflornithine
Hide Arm/Group Description Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days). Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
All-Cause Mortality
Arm I: Celecoxib and Placebo Arm II: Celecoxib and Eflornithine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Arm I: Celecoxib and Placebo Arm II: Celecoxib and Eflornithine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   3/57 (5.26%) 
Gastrointestinal disorders     
Obstruction: Small Bowel NOS † 1  0/55 (0.00%)  1/57 (1.75%) 
Perforation GI - Colon † 1  0/55 (0.00%)  1/57 (1.75%) 
Hepatobiliary disorders     
Pancreatitis † 1  0/55 (0.00%)  1/57 (1.75%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I: Celecoxib and Placebo Arm II: Celecoxib and Eflornithine
Affected / at Risk (%) Affected / at Risk (%)
Total   53/55 (96.36%)   48/57 (84.21%) 
Blood and lymphatic system disorders     
Hemoglobin Change † 1  0/55 (0.00%)  2/57 (3.51%) 
Lymphopenia † 1  0/55 (0.00%)  1/57 (1.75%) 
Low Platelet † 1  0/55 (0.00%)  2/57 (3.51%) 
Bloody stools † 1  0/55 (0.00%)  1/57 (1.75%) 
Hand & Wrist, Hemorrhage/Bleeding † 1  0/55 (0.00%)  1/57 (1.75%) 
Hematuria † 1  1/55 (1.82%)  0/57 (0.00%) 
Nose Bleed † 1  2/55 (3.64%)  1/57 (1.75%) 
Rectum, Hemorrhage/Bleeding † 1  4/55 (7.27%)  5/57 (8.77%) 
Vagina, Hemorrhage/Bleeding † 1  0/55 (0.00%)  1/57 (1.75%) 
Edema † 1  4/55 (7.27%)  6/57 (10.53%) 
Cardiac disorders     
Cardiac ischemia (unstable angina) † 1  1/55 (1.82%)  0/57 (0.00%) 
Chest tightness † 1  1/55 (1.82%)  1/57 (1.75%) 
Hypertension † 1  3/55 (5.45%)  1/57 (1.75%) 
Orthostatic Hypotension † 1  1/55 (1.82%)  0/57 (0.00%) 
Palpitations † 1  3/55 (5.45%)  2/57 (3.51%) 
Ear and labyrinth disorders     
High Frequency Hearing loss † 1  5/55 (9.09%)  7/57 (12.28%) 
Otitis † 1  8/55 (14.55%)  3/57 (5.26%) 
Tinnitus † 1  5/55 (9.09%)  3/57 (5.26%) 
Hearing Impairment/Loss † 1  7/55 (12.73%)  4/57 (7.02%) 
Endocrine disorders     
Hot flashes † 1  2/55 (3.64%)  2/57 (3.51%) 
Eye disorders     
Blurred Vision † 1 [1]  3/55 (5.45%)  1/57 (1.75%) 
Bright lights † 1  1/55 (1.82%)  0/57 (0.00%) 
Decreased vision (left eye) † 1  1/55 (1.82%)  0/57 (0.00%) 
Decreased visual acuity † 1  1/55 (1.82%)  0/57 (0.00%) 
Dry eye syndrome † 1  0/55 (0.00%)  1/57 (1.75%) 
Eyelid scratch † 1  1/55 (1.82%)  0/57 (0.00%) 
Near sighted † 1  0/55 (0.00%)  1/57 (1.75%) 
Photophobia † 1  0/55 (0.00%)  1/57 (1.75%) 
Tired eyes † 1  1/55 (1.82%)  0/57 (0.00%) 
Unequal pupils † 1  1/55 (1.82%)  0/57 (0.00%) 
Vision-floaters † 1  0/55 (0.00%)  1/57 (1.75%) 
Watery eye † 1  0/55 (0.00%)  1/57 (1.75%) 
Yellow discoloration (right ey † 1  0/55 (0.00%)  1/57 (1.75%) 
Gastrointestinal disorders     
Anorexia † 1  1/55 (1.82%)  3/57 (5.26%) 
Flatulence † 1 [2]  4/55 (7.27%)  3/57 (5.26%) 
Constipation † 1  1/55 (1.82%)  2/57 (3.51%) 
Dehydration † 1  1/55 (1.82%)  0/57 (0.00%) 
Diarrhea † 1  17/55 (30.91%)  15/57 (26.32%) 
Dry mouth † 1  0/55 (0.00%)  1/57 (1.75%) 
Dysphagia † 1  1/55 (1.82%)  0/57 (0.00%) 
Esophagitis † 1  1/55 (1.82%)  1/57 (1.75%) 
Heartburn/Dyspepsia † 1  14/55 (25.45%)  11/57 (19.30%) 
Mucositis/Stomatitis † 1  15/55 (27.27%)  23/57 (40.35%) 
Nausea/Vomiting † 1  12/55 (21.82%)  16/57 (28.07%) 
Stricture: Rectum † 1  0/55 (0.00%)  1/57 (1.75%) 
Taste alteration † 1  0/55 (0.00%)  1/57 (1.75%) 
Ulcers † 1 [3]  1/55 (1.82%)  1/57 (1.75%) 
General disorders     
Fatigue † 1  16/55 (29.09%)  12/57 (21.05%) 
Fever † 1  1/55 (1.82%)  2/57 (3.51%) 
Insomnia † 1  7/55 (12.73%)  4/57 (7.02%) 
Night sweats † 1  0/55 (0.00%)  1/57 (1.75%) 
Weight gain † 1  8/55 (14.55%)  6/57 (10.53%) 
Weight loss † 1  1/55 (1.82%)  2/57 (3.51%) 
Pain, Abdomen † 1 [4]  14/55 (25.45%)  9/57 (15.79%) 
Pain, Wrist, Arm & Shoulder † 1  2/55 (3.64%)  2/57 (3.51%) 
Pain, Back † 1 [5]  5/55 (9.09%)  4/57 (7.02%) 
Pain, Breast (tenderness) † 1  0/55 (0.00%)  1/57 (1.75%) 
Pain, Breast bone † 1  0/55 (0.00%)  1/57 (1.75%) 
Pain, Cardiac/Heart † 1  1/55 (1.82%)  1/57 (1.75%) 
Pain, Chest/thorax NOS † 1  1/55 (1.82%)  1/57 (1.75%) 
Pain, Ear † 1  2/55 (3.64%)  3/57 (5.26%) 
Pain, Extremity-limb † 1  2/55 (3.64%)  0/57 (0.00%) 
Pain, Groin/Loin/Thigh † 1  1/55 (1.82%)  2/57 (3.51%) 
Headache † 1  16/55 (29.09%)  14/57 (24.56%) 
Pain, Joint/Musculoskeletal † 1  6/55 (10.91%)  2/57 (3.51%) 
Pain, Muscle † 1  4/55 (7.27%)  2/57 (3.51%) 
Pain, Neck † 1  1/55 (1.82%)  0/57 (0.00%) 
Pain, Oral-gums † 1  1/55 (1.82%)  0/57 (0.00%) 
Pain, Rectum † 1  2/55 (3.64%)  1/57 (1.75%) 
Pain, Throat/Pharynx † 1  1/55 (1.82%)  6/57 (10.53%) 
Pain, Vagina (cramping) † 1  0/55 (0.00%)  1/57 (1.75%) 
Immune system disorders     
Allergies, seasonal † 1  0/55 (0.00%)  2/57 (3.51%) 
Allergic rhinitis † 1  3/55 (5.45%)  0/57 (0.00%) 
Allergic reaction (food) † 1  0/55 (0.00%)  1/57 (1.75%) 
Infections and infestations     
Cold Sore (mouth) † 1  1/55 (1.82%)  0/57 (0.00%) 
Conjunctiva † 1  0/55 (0.00%)  1/57 (1.75%) 
Ear Infection † 1  0/55 (0.00%)  1/57 (1.75%) 
Head & Nasal Infection † 1  1/55 (1.82%)  0/57 (0.00%) 
Head (fungus) Infection † 1  1/55 (1.82%)  0/57 (0.00%) 
Lung Infection (pneumonia) † 1  1/55 (1.82%)  0/57 (0.00%) 
Infection, Nose (yellow nasal drainage) † 1  1/55 (1.82%)  0/57 (0.00%) 
Infection, Right leg (spider bite) † 1  0/55 (0.00%)  1/57 (1.75%) 
Sinus Infection † 1  1/55 (1.82%)  0/57 (0.00%) 
Infection, Stomach † 1  2/55 (3.64%)  3/57 (5.26%) 
Infection, Ungual † 1  0/55 (0.00%)  2/57 (3.51%) 
Infection, Upper airway NOS † 1  3/55 (5.45%)  3/57 (5.26%) 
Injury, poisoning and procedural complications     
Intra-Operative Injury Extremity-Upper † 1  1/55 (1.82%)  0/57 (0.00%) 
Metabolism and nutrition disorders     
ALT, SGPT Changes † 1  1/55 (1.82%)  1/57 (1.75%) 
AST, SGOT Changes † 1  0/55 (0.00%)  1/57 (1.75%) 
Alkaline phosphatase Changes † 1  1/55 (1.82%)  0/57 (0.00%) 
Creatinine Changes † 1  0/55 (0.00%)  1/57 (1.75%) 
Elevated LDL † 1  0/55 (0.00%)  1/57 (1.75%) 
Hyperbilirubinemia † 1  2/55 (3.64%)  0/57 (0.00%) 
Hypercholestremia & Hypertriglyceridemia † 1  1/55 (1.82%)  1/57 (1.75%) 
Hypocalcemia † 1  0/55 (0.00%)  1/57 (1.75%) 
Hypophosphatemia † 1  0/55 (0.00%)  1/57 (1.75%) 
Proteinuria † 1  1/55 (1.82%)  1/57 (1.75%) 
Musculoskeletal and connective tissue disorders     
Ankle Sprain † 1  0/55 (0.00%)  1/57 (1.75%) 
Bursitis † 1  0/55 (0.00%)  1/57 (1.75%) 
Muscle weakness, Extremity-lower † 1 [6]  1/55 (1.82%)  2/57 (3.51%) 
Fracture † 1  0/55 (0.00%)  1/57 (1.75%) 
Muscle/bone soreness from fall † 1  0/55 (0.00%)  1/57 (1.75%) 
Jaw tightness (left side) † 1  1/55 (1.82%)  0/57 (0.00%) 
Lower jaw tear † 1  0/55 (0.00%)  1/57 (1.75%) 
Puncture wound † 1  0/55 (0.00%)  1/57 (1.75%) 
Sutures in shoulder † 1  1/55 (1.82%)  0/57 (0.00%) 
Gout † 1  0/55 (0.00%)  1/57 (1.75%) 
Nervous system disorders     
Cognitive Disturbance (ADD) † 1 [7]  1/55 (1.82%)  0/57 (0.00%) 
Dizziness † 1  7/55 (12.73%)  6/57 (10.53%) 
Memory Impairment † 1  1/55 (1.82%)  1/57 (1.75%) 
Mood Alteration : Anxiety † 1  2/55 (3.64%)  0/57 (0.00%) 
Mood alteration : Depression † 1  1/55 (1.82%)  1/57 (1.75%) 
Numbness † 1  3/55 (5.45%)  2/57 (3.51%) 
Numbness & Tingling † 1  1/55 (1.82%)  0/57 (0.00%) 
Peripheral Neuropathy † 1  1/55 (1.82%)  0/57 (0.00%) 
Somnolence † 1  0/55 (0.00%)  1/57 (1.75%) 
Tingling † 1  0/55 (0.00%)  1/57 (1.75%) 
Renal and urinary disorders     
Burning with urination † 1  0/55 (0.00%)  1/57 (1.75%) 
Crystals in urine † 1  1/55 (1.82%)  0/57 (0.00%) 
Kidney stone † 1  1/55 (1.82%)  0/57 (0.00%) 
Urinary frequency † 1  1/55 (1.82%)  0/57 (0.00%) 
Reproductive system and breast disorders     
Erectile dysfunction † 1  1/55 (1.82%)  0/57 (0.00%) 
Irregular menses † 1  1/55 (1.82%)  0/57 (0.00%) 
Irritation around genitals † 1  1/55 (1.82%)  0/57 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Bronchospasm, wheezing † 1 [8]  4/55 (7.27%)  0/57 (0.00%) 
Congestion † 1  1/55 (1.82%)  1/57 (1.75%) 
Cough † 1  10/55 (18.18%)  6/57 (10.53%) 
Dyspnea † 1  8/55 (14.55%)  0/57 (0.00%) 
Nasal cavity/paranasal sinus reaction † 1  3/55 (5.45%)  3/57 (5.26%) 
Skin and subcutaneous tissue disorders     
Bruising † 1  3/55 (5.45%)  3/57 (5.26%) 
Hair loss/alopecia † 1  2/55 (3.64%)  0/57 (0.00%) 
Nail changes † 1  0/55 (0.00%)  2/57 (3.51%) 
Nodules † 1  1/55 (1.82%)  1/57 (1.75%) 
Pruritis/Itching † 1  5/55 (9.09%)  4/57 (7.02%) 
Psoriasis † 1  0/55 (0.00%)  1/57 (1.75%) 
Rash & Itching † 1  6/55 (10.91%)  6/57 (10.53%) 
Other skin issues † 1  0/55 (0.00%)  3/57 (5.26%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Ocular/Visual
[2]
Burp, Distension/Bloating, Gas
[3]
Ileorectal Anastomosis, Rectum
[4]
Pain
[5]
Flank and sides
[6]
Gait and standing
[7]
Neurology
[8]
Pulmonary/Upper Respiratory
Following reports of COX-2 inhibitor-associated cardiovascular toxicities, trial suspended from December 17, 2004 to March 18, 2005 pending reevaluation of cardiovascular risks, only two sites resumed the trial.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Patrick Lynch, MD/Professor, Gastroenterology/Hepatology
Organization: University of Texas (UT) MD Anderson Cancer Center
Phone: 713-794-5073
EMail: plynch@mdanderson.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00033371    
Other Study ID Numbers: NCI-2013-00844
NCI-2013-00844 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
N01-CN95040
CDR0000069278
NCI-P02-0219
ID00-109 ( Other Identifier: MD Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
MDA-ID-00109 ( Other Identifier: MD Anderson Cancer Network )
N01-CN-95040 ( Other Identifier: DCP )
N01CN95040 ( Other Identifier: US NIH Grant/Contract Award Number )
First Submitted: April 9, 2002
First Posted: January 27, 2003
Results First Submitted: January 26, 2015
Results First Posted: February 4, 2015
Last Update Posted: September 29, 2020