Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Gemcitabine Hydrochloride or Pemetrexed Disodium and Carboplatin With or Without Celecoxib in Treating Patients With Advanced Non-Small Cell Lung 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: NCT01041781
Recruitment Status : Terminated (DSMB recommendation)
First Posted : January 1, 2010
Results First Posted : July 23, 2018
Last Update Posted : July 23, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Drug: carboplatin
Drug: celecoxib
Drug: gemcitabine hydrochloride
Drug: pemetrexed disodium
Other: placebo
Enrollment 313
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Arm A: Celecoxib + Standard Chemotherapy) Arm II (Arm B: Placebo + Standard Chemotherapy)
Hide Arm/Group Description Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5 (Patient with prior chest radiotherapy should receive carboplatin at an AUC = 5.0); Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and 400 mg oral celecoxib twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days). Following 6 cycles of therapy, those patients with responding or stable disease will continue on the celecoxib/placebo until disease progression or unacceptable toxicity. Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and placebo twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days).
Period Title: Overall Study
Started 154 158
Completed 154 158
Not Completed 0 0
Arm/Group Title Arm I (Arm A: Celecoxib + Standard Chemotherapy) Arm II (Arm B: Placebo + Standard Chemotherapy) Total
Hide Arm/Group Description Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5 (Patient with prior chest radiotherapy should receive carboplatin at an AUC = 5.0); Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and 400 mg oral celecoxib twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days). Following 6 cycles of therapy, those patients with responding or stable disease will continue on the celecoxib/placebo until disease progression or unacceptable toxicity. Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and placebo twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days). Total of all reporting groups
Overall Number of Baseline Participants 154 158 312
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 154 participants 158 participants 312 participants
64.0
(38.0 to 83.0)
64.0
(36.0 to 89.0)
64.0
(36.0 to 89.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 154 participants 158 participants 312 participants
Female
72
  46.8%
71
  44.9%
143
  45.8%
Male
82
  53.2%
87
  55.1%
169
  54.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 154 participants 158 participants 312 participants
154
 100.0%
158
 100.0%
312
 100.0%
1.Primary Outcome
Title Progression-free Survival
Hide Description Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Time Frame Time between randomization and disease relapse or death from any cause, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Arm A: Celecoxib + Standard Chemotherapy) Arm II (Arm B: Placebo + Standard Chemotherapy)
Hide Arm/Group Description:
Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5 (Patient with prior chest radiotherapy should receive carboplatin at an AUC = 5.0); Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and 400 mg oral celecoxib twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days). Following 6 cycles of therapy, those patients with responding or stable disease will continue on the celecoxib/placebo until disease progression or unacceptable toxicity.
Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and placebo twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days).
Overall Number of Participants Analyzed 154 158
Median (95% Confidence Interval)
Unit of Measure: months
5.16
(4.40 to 5.78)
5.26
(4.40 to 6.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Arm A: Celecoxib + Standard Chemotherapy), Arm II (Arm B: Placebo + Standard Chemotherapy)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5346
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.076
Confidence Interval (2-Sided) 95%
0.853 to 1.367
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival
Hide Description Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Time Frame Time between randomization and death from any cause, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Arm A: Celecoxib + Standard Chemotherapy) Arm II (Arm B: Placebo + Standard Chemotherapy)
Hide Arm/Group Description:
Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and 400 mg oral celecoxib twice daily on days 1-21.
Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and placebo twice daily on days 1-21.
Overall Number of Participants Analyzed 154 158
Median (95% Confidence Interval)
Unit of Measure: months
11.4
(9.46 to 14.06)
12.5
(9.36 to 13.83)
3.Secondary Outcome
Title Response Rate
Hide Description The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients. Response rates (including complete and partial response) will be tested using Fisher's exact test
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Arm A: Celecoxib + Standard Chemotherapy) Arm II (Arm B: Placebo + Standard Chemotherapy)
Hide Arm/Group Description:
Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5 (Patient with prior chest radiotherapy should receive carboplatin at an AUC = 5.0); Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and 400 mg oral celecoxib twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days). Following 6 cycles of therapy, those patients with responding or stable disease will continue on the celecoxib/placebo until disease progression or unacceptable toxicity.
Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and placebo twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days).
Overall Number of Participants Analyzed 154 158
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
40
(32 to 48)
35
(27 to 43)
4.Secondary Outcome
Title Incidence of Toxicities as Assessed by NCI CTCAE v. 4.0
Hide Description The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Arm A: Celecoxib + Standard Chemotherapy) Arm II (Arm B: Placebo + Standard Chemotherapy)
Hide Arm/Group Description:
Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and 400 mg oral celecoxib twice daily on days 1-21.
Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and placebo twice daily on days 1-21.
Overall Number of Participants Analyzed 154 158
Measure Type: Number
Unit of Measure: percentage of patients
61.04 55.06
5.Secondary Outcome
Title Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the First Quartile (Q1)
Hide Description Prognostic value of urinary prostaglandin metabolites (PGE-M) levels for worse PFS for patients who had baseline urinary PGE-M above/below the first quartile (Q1, 10.09). Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients on the placebo arm with urinary PGE-M evaluated at baseline were included in the analysis.
Arm/Group Title PGE-M < Q1 PGE-M >= Q1
Hide Arm/Group Description:
Patients with urinary PGE-M < Q1 (10.09) at baseline
Patients with urinary PGE-M >= Q1 (10.09) at baseline
Overall Number of Participants Analyzed 27 78
Median (95% Confidence Interval)
Unit of Measure: months
7.7
(4.40 to 13.14)
4.9
(3.81 to 6.14)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PGE-M < Q1, PGE-M >= Q1
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0049
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
6.Secondary Outcome
Title Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the Median Quartile (Q2)
Hide Description prognostic value of urinary prostaglandin metabolites (PGE-M) levels for worse PFS for patients who had baseline urinary PGE-M above/below the median quartile (Q2, 15.38). Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients on the placebo arm with urinary PGE-M evaluated at baseline were included in the analysis.
Arm/Group Title PGE-M < Q2 PGE-M >= Q2
Hide Arm/Group Description:
Patients with urinary PGE-M < Q2 (15.38) at baseline
Patients with urinary PGE-M >= Q2 (15.38) at baseline
Overall Number of Participants Analyzed 56 49
Median (95% Confidence Interval)
Unit of Measure: months
6.2
(4.40 to 7.49)
4.2
(3.42 to 5.78)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PGE-M < Q2, PGE-M >= Q2
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0131
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
7.Secondary Outcome
Title Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the Third Quartile (Q3)
Hide Description Prognostic value of urinary prostaglandin metabolites (PGE-M) levels for worse PFS for patients who had baseline urinary PGE-M above/below the median quartile (Q3, 27.86). Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients on the placebo arm with urinary PGE-M evaluated at baseline were included in the analysis.
Arm/Group Title PGE-M < Q3 PGE-M >= Q3
Hide Arm/Group Description:
Patients with urinary PGE-M < Q3 (27.86) at baseline
Patients with urinary PGE-M >= Q3 (27.86) at baseline
Overall Number of Participants Analyzed 79 26
Median (95% Confidence Interval)
Unit of Measure: months
6.0
(4.50 to 7.23)
3.0
(1.77 to 5.09)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PGE-M < Q3, PGE-M >= Q3
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0322
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Time Frame Adverse events (AE) are collected each cycle during protocol therapy. AE forms are submitted until all protocol treatment related events have resolved or until non protocol treatment begins; Up to 5 years.
Adverse Event Reporting Description Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
 
Arm/Group Title Arm I (Arm A: Celecoxib + Standard Chemotherapy) Arm II (Arm B: Placebo + Standard Chemotherapy)
Hide Arm/Group Description Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5 (Patient with prior chest radiotherapy should receive carboplatin at an AUC = 5.0); Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and 400 mg oral celecoxib twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days). Following 6 cycles of therapy, those patients with responding or stable disease will continue on the celecoxib/placebo until disease progression or unacceptable toxicity. Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1 and 8 (for those with squamous carcinoma) OR 500 mg/m^2 pemetrexed disodium IV on day 1 (for those with non-squamous carcinoma). Patients also receive (Squamous carcinoma patients: AUC=5.5; Non-squamous carcinoma patients: AUC=6.0) carboplatin IV on day 1 and placebo twice daily on days 1-21. Patients may receive a maximum of 6 cycles of therapy (1 cycle = 21 days).
All-Cause Mortality
Arm I (Arm A: Celecoxib + Standard Chemotherapy) Arm II (Arm B: Placebo + Standard Chemotherapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   15/146 (10.27%)      9/148 (6.08%)    
Hide Serious Adverse Events
Arm I (Arm A: Celecoxib + Standard Chemotherapy) Arm II (Arm B: Placebo + Standard Chemotherapy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/146 (21.23%)      21/148 (14.19%)    
Blood and lymphatic system disorders     
Anemia  1  22/146 (15.07%)  26 17/148 (11.49%)  19
Blood and lymphatic system disorders - Other, specify  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Febrile neutropenia  1  3/146 (2.05%)  3 1/148 (0.68%)  1
Leukocytosis  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Cardiac disorders     
Atrial fibrillation  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Cardiac arrest  1  2/146 (1.37%)  2 1/148 (0.68%)  1
Myocardial infarction  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Pericardial effusion  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Pericardial tamponade  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Sinus bradycardia  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Ventricular tachycardia  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Colitis  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Constipation  1  1/146 (0.68%)  1 1/148 (0.68%)  1
Diarrhea  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Duodenal hemorrhage  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Duodenal perforation  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Ileus  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Lower gastrointestinal hemorrhage  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Mucositis oral  1  3/146 (2.05%)  3 0/148 (0.00%)  0
Nausea  1  2/146 (1.37%)  2 1/148 (0.68%)  1
Oral pain  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Upper gastrointestinal hemorrhage  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Vomiting  1  7/146 (4.79%)  7 1/148 (0.68%)  1
General disorders     
Death NOS  1  5/146 (3.42%)  5 4/148 (2.70%)  4
Fatigue  1  20/146 (13.70%)  23 15/148 (10.14%)  17
Fever  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Pain  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Immune system disorders     
Allergic reaction  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Infections and infestations     
Esophageal infection  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Lung infection  1  1/146 (0.68%)  1 2/148 (1.35%)  2
Sepsis  1  4/146 (2.74%)  4 1/148 (0.68%)  1
Urinary tract infection  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Injury, poisoning and procedural complications     
Fall  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Investigations     
Alanine aminotransferase increased  1  2/146 (1.37%)  3 1/148 (0.68%)  1
Alkaline phosphatase increased  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Aspartate aminotransferase increased  1  3/146 (2.05%)  4 1/148 (0.68%)  1
Blood bilirubin increased  1  3/146 (2.05%)  3 2/148 (1.35%)  2
CPK increased  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Cardiac troponin I increased  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Lipase increased  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Lymphocyte count decreased  1  2/146 (1.37%)  3 2/148 (1.35%)  2
Neutrophil count decreased  1  8/146 (5.48%)  8 9/148 (6.08%)  10
Platelet count decreased  1  16/146 (10.96%)  17 12/148 (8.11%)  12
White blood cell decreased  1  2/146 (1.37%)  2 4/148 (2.70%)  4
Metabolism and nutrition disorders     
Acidosis  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Anorexia  1  5/146 (3.42%)  5 6/148 (4.05%)  6
Dehydration  1  2/146 (1.37%)  2 3/148 (2.03%)  3
Hypercalcemia  1  1/146 (0.68%)  1 1/148 (0.68%)  1
Hyperglycemia  1  3/146 (2.05%)  3 1/148 (0.68%)  1
Hyperkalemia  1  1/146 (0.68%)  1 1/148 (0.68%)  1
Hyperuricemia  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Hypoalbuminemia  1  2/146 (1.37%)  2 2/148 (1.35%)  2
Hypokalemia  1  2/146 (1.37%)  2 1/148 (0.68%)  1
Hyponatremia  1  8/146 (5.48%)  8 2/148 (1.35%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Back pain  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Generalized muscle weakness  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, specify  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Myositis  1  0/146 (0.00%)  0 1/148 (0.68%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Nervous system disorders     
Cognitive disturbance  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Dizziness  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Ischemia cerebrovascular  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Stroke  1  1/146 (0.68%)  1 1/148 (0.68%)  1
Psychiatric disorders     
Depression  1  1/146 (0.68%)  1 1/148 (0.68%)  1
Insomnia  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Restlessness  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Renal and urinary disorders     
Acute kidney injury  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Aspiration  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Bronchopulmonary hemorrhage  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Cough  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Dyspnea  1  2/146 (1.37%)  2 4/148 (2.70%)  4
Epistaxis  1  1/146 (0.68%)  1 1/148 (0.68%)  1
Hypoxia  1  2/146 (1.37%)  2 0/148 (0.00%)  0
Pleural effusion  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Pneumonitis  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Pulmonary edema  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Respiratory failure  1  3/146 (2.05%)  3 0/148 (0.00%)  0
Skin and subcutaneous tissue disorders     
Pruritus  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Rash maculo-papular  1  3/146 (2.05%)  4 1/148 (0.68%)  1
Vascular disorders     
Hypotension  1  1/146 (0.68%)  1 1/148 (0.68%)  1
Superior vena cava syndrome  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Thromboembolic event  1  2/146 (1.37%)  2 1/148 (0.68%)  1
Visceral arterial ischemia  1  1/146 (0.68%)  1 0/148 (0.00%)  0
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Arm A: Celecoxib + Standard Chemotherapy) Arm II (Arm B: Placebo + Standard Chemotherapy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   135/146 (92.47%)      140/148 (94.59%)    
Blood and lymphatic system disorders     
Anemia  1  120/146 (82.19%)  566 123/148 (83.11%)  490
Blood and lymphatic system disorders - Other, specify  1  1/146 (0.68%)  1 1/148 (0.68%)  3
Febrile neutropenia  1  3/146 (2.05%)  3 2/148 (1.35%)  2
Leukocytosis  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Cardiac disorders     
Atrial fibrillation  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Palpitations  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Pericardial effusion  1  2/146 (1.37%)  2 0/148 (0.00%)  0
Ear and labyrinth disorders     
Hearing impaired  1  3/146 (2.05%)  5 0/148 (0.00%)  0
Vertigo  1  1/146 (0.68%)  3 0/148 (0.00%)  0
Endocrine disorders     
Hypothyroidism  1  1/146 (0.68%)  2 0/148 (0.00%)  0
Eye disorders     
Blurred vision  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Eye disorders - Other, specify  1  2/146 (1.37%)  2 0/148 (0.00%)  0
Watering eyes  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  5/146 (3.42%)  5 1/148 (0.68%)  1
Constipation  1  6/146 (4.11%)  10 5/148 (3.38%)  7
Diarrhea  1  3/146 (2.05%)  5 5/148 (3.38%)  5
Dry mouth  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Dyspepsia  1  0/146 (0.00%)  0 2/148 (1.35%)  2
Dysphagia  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Esophagitis  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Gastritis  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Gastrointestinal pain  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Hemorrhoidal hemorrhage  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Hemorrhoids  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Jejunal hemorrhage  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Mucositis oral  1  31/146 (21.23%)  47 23/148 (15.54%)  34
Nausea  1  6/146 (4.11%)  7 11/148 (7.43%)  16
Oral hemorrhage  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Rectal hemorrhage  1  2/146 (1.37%)  2 1/148 (0.68%)  1
Rectal pain  1  1/146 (0.68%)  1 1/148 (0.68%)  1
Upper gastrointestinal hemorrhage  1  1/146 (0.68%)  2 0/148 (0.00%)  0
Vomiting  1  48/146 (32.88%)  79 32/148 (21.62%)  48
General disorders     
Edema limbs  1  2/146 (1.37%)  2 3/148 (2.03%)  3
Fatigue  1  109/146 (74.66%)  423 115/148 (77.70%)  418
Fever  1  1/146 (0.68%)  1 1/148 (0.68%)  1
General disorders and administration site conditions - Other, specify  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Non-cardiac chest pain  1  4/146 (2.74%)  12 4/148 (2.70%)  5
Pain  1  5/146 (3.42%)  5 4/148 (2.70%)  9
Hepatobiliary disorders     
Cholecystitis  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Immune system disorders     
Allergic reaction  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Infections and infestations     
Infections and infestations - Other, specify  1  2/146 (1.37%)  2 0/148 (0.00%)  0
Lung infection  1  9/146 (6.16%)  12 1/148 (0.68%)  1
Mucosal infection  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Otitis media  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Skin infection  1  0/146 (0.00%)  0 2/148 (1.35%)  2
Tooth infection  1  0/146 (0.00%)  0 1/148 (0.68%)  2
Urinary tract infection  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Hip fracture  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  4/146 (2.74%)  5 2/148 (1.35%)  7
Alkaline phosphatase increased  1  2/146 (1.37%)  4 3/148 (2.03%)  10
Aspartate aminotransferase increased  1  2/146 (1.37%)  2 2/148 (1.35%)  7
Blood bilirubin increased  1  5/146 (3.42%)  6 4/148 (2.70%)  6
CD4 lymphocytes decreased  1  2/146 (1.37%)  6 1/148 (0.68%)  1
Cholesterol high  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Creatinine increased  1  1/146 (0.68%)  3 1/148 (0.68%)  1
Hemoglobin increased  1  1/146 (0.68%)  1 0/148 (0.00%)  0
INR increased  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Investigations - Other, specify  1  3/146 (2.05%)  3 1/148 (0.68%)  1
Lymphocyte count decreased  1  13/146 (8.90%)  17 16/148 (10.81%)  36
Lymphocyte count increased  1  2/146 (1.37%)  2 1/148 (0.68%)  1
Neutrophil count decreased  1  66/146 (45.21%)  150 67/148 (45.27%)  138
Platelet count decreased  1  77/146 (52.74%)  207 78/148 (52.70%)  173
Weight loss  1  2/146 (1.37%)  3 2/148 (1.35%)  2
White blood cell decreased  1  15/146 (10.27%)  20 16/148 (10.81%)  26
Metabolism and nutrition disorders     
Anorexia  1  67/146 (45.89%)  160 64/148 (43.24%)  136
Dehydration  1  8/146 (5.48%)  13 5/148 (3.38%)  6
Hypercalcemia  1  2/146 (1.37%)  3 2/148 (1.35%)  2
Hyperglycemia  1  9/146 (6.16%)  20 8/148 (5.41%)  13
Hyperkalemia  1  2/146 (1.37%)  3 1/148 (0.68%)  2
Hypermagnesemia  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Hypernatremia  1  0/146 (0.00%)  0 1/148 (0.68%)  2
Hypoalbuminemia  1  5/146 (3.42%)  8 1/148 (0.68%)  3
Hypocalcemia  1  1/146 (0.68%)  3 1/148 (0.68%)  2
Hypoglycemia  1  1/146 (0.68%)  3 0/148 (0.00%)  0
Hypokalemia  1  4/146 (2.74%)  5 6/148 (4.05%)  9
Hypomagnesemia  1  0/146 (0.00%)  0 2/148 (1.35%)  2
Hyponatremia  1  16/146 (10.96%)  37 5/148 (3.38%)  5
Hypophosphatemia  1  0/146 (0.00%)  0 3/148 (2.03%)  4
Musculoskeletal and connective tissue disorders     
Arthralgia  1  5/146 (3.42%)  10 4/148 (2.70%)  11
Back pain  1  4/146 (2.74%)  7 12/148 (8.11%)  29
Bone pain  1  2/146 (1.37%)  2 3/148 (2.03%)  7
Buttock pain  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Chest wall pain  1  1/146 (0.68%)  1 3/148 (2.03%)  11
Flank pain  1  1/146 (0.68%)  1 1/148 (0.68%)  2
Generalized muscle weakness  1  1/146 (0.68%)  1 2/148 (1.35%)  2
Musculoskeletal and connective tissue disorder - Other, specify  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Myalgia  1  2/146 (1.37%)  2 2/148 (1.35%)  4
Neck pain  1  2/146 (1.37%)  2 1/148 (0.68%)  2
Pain in extremity  1  2/146 (1.37%)  3 2/148 (1.35%)  3
Nervous system disorders     
Dizziness  1  3/146 (2.05%)  3 2/148 (1.35%)  3
Extrapyramidal disorder  1  0/146 (0.00%)  0 1/148 (0.68%)  2
Headache  1  3/146 (2.05%)  3 3/148 (2.03%)  10
Ischemia cerebrovascular  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Neuralgia  1  0/146 (0.00%)  0 1/148 (0.68%)  2
Peripheral motor neuropathy  1  2/146 (1.37%)  3 1/148 (0.68%)  1
Peripheral sensory neuropathy  1  2/146 (1.37%)  5 0/148 (0.00%)  0
Stroke  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Syncope  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Tremor  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Psychiatric disorders     
Anxiety  1  2/146 (1.37%)  2 1/148 (0.68%)  1
Confusion  1  2/146 (1.37%)  2 2/148 (1.35%)  2
Depression  1  1/146 (0.68%)  2 0/148 (0.00%)  0
Insomnia  1  1/146 (0.68%)  1 3/148 (2.03%)  3
Renal and urinary disorders     
Acute kidney injury  1  2/146 (1.37%)  2 0/148 (0.00%)  0
Chronic kidney disease  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Hematuria  1  0/146 (0.00%)  0 2/148 (1.35%)  2
Reproductive system and breast disorders     
Breast pain  1  0/146 (0.00%)  0 1/148 (0.68%)  2
Penile pain  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Vaginal hemorrhage  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Aspiration  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Atelectasis  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Bronchopulmonary hemorrhage  1  0/146 (0.00%)  0 2/148 (1.35%)  3
Cough  1  5/146 (3.42%)  7 1/148 (0.68%)  1
Dyspnea  1  10/146 (6.85%)  13 6/148 (4.05%)  9
Epistaxis  1  3/146 (2.05%)  4 3/148 (2.03%)  4
Hoarseness  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Hypoxia  1  3/146 (2.05%)  3 2/148 (1.35%)  2
Laryngeal hemorrhage  1  0/146 (0.00%)  0 2/148 (1.35%)  2
Pleural effusion  1  2/146 (1.37%)  2 1/148 (0.68%)  1
Pleural hemorrhage  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Pleuritic pain  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Pneumonitis  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Respiratory, thoracic and mediastinal disorders - Other, specify  1  2/146 (1.37%)  4 0/148 (0.00%)  0
Sore throat  1  2/146 (1.37%)  2 0/148 (0.00%)  0
Voice alteration  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia  1  2/146 (1.37%)  2 0/148 (0.00%)  0
Erythema multiforme  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Hyperhidrosis  1  0/146 (0.00%)  0 2/148 (1.35%)  2
Pruritus  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Rash maculo-papular  1  22/146 (15.07%)  40 15/148 (10.14%)  20
Skin hyperpigmentation  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Urticaria  1  0/146 (0.00%)  0 1/148 (0.68%)  1
Vascular disorders     
Hypertension  1  0/146 (0.00%)  0 3/148 (2.03%)  4
Hypotension  1  1/146 (0.68%)  1 2/148 (1.35%)  2
Superior vena cava syndrome  1  1/146 (0.68%)  1 0/148 (0.00%)  0
Thromboembolic event  1  4/146 (2.74%)  6 8/148 (5.41%)  13
Vascular disorders - Other, specify  1  1/146 (0.68%)  1 0/148 (0.00%)  0
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
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: Martin J. Edelman, M.D.
Organization: Fox Chase Cancer Center
Phone: (215) 728-4790
EMail: martin.edelman@fccc.edu
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01041781    
Other Study ID Numbers: CALGB-30801
CALGB-30801
CDR0000662707 ( Registry Identifier: NCI Physician Data Query )
First Submitted: December 31, 2009
First Posted: January 1, 2010
Results First Submitted: June 26, 2018
Results First Posted: July 23, 2018
Last Update Posted: July 23, 2018