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Celecoxib and Docetaxel or Pemetrexed in Treating Patients With Advanced Recurrent Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00520845
Recruitment Status : Terminated (slow accrual)
First Posted : August 27, 2007
Results First Posted : October 9, 2014
Last Update Posted : March 20, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Leora Horn, MD, Vanderbilt-Ingram Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Drug: celecoxib
Drug: Docetaxel
Drug: pemetrexed disodium
Other: laboratory biomarker analysis
Enrollment 23
Recruitment Details This study opened October 2007 and ran to December 2013. All patients were recruited from Vanderbilt-Ingram Cancer Center.
Pre-assignment Details This study included a "run-in phase" of celecoxib 600 mg BID x 5-7 day, following patient enrollment. Patients with ≥70% decrease in PGE-M level, were considered "COX dependent" and protocol eligible making them eligible for protocol treatment. Patients with <70% decrease in PGE-M level were not eligible.
Arm/Group Title Treatment Arm
Hide Arm/Group Description

Either docetaxel or pemetrexed given with celecoxib

celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.

Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle

pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.

laboratory biomarker analysis: Blood collection

Period Title: Overall Study
Started 23
Completed 1
Not Completed 22
Reason Not Completed
Death             3
Adverse Event             4
Disease Progression, relapse             13
Withdrawal by Subject             1
Alternative Therapy             1
Arm/Group Title Treatment Arm
Hide Arm/Group Description

Either docetaxel or pemetrexed given with celecoxib

celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.

Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle

pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.

laboratory biomarker analysis: Blood collection

Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 23 participants
63.26
(41 to 79)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
  47.8%
>=65 years
12
  52.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
8
  34.8%
Male
15
  65.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants
23
1.Primary Outcome
Title Median Survival
Hide Description Estimated probable duration of life from on-study date to date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details)
Time Frame 2 years from date of registration
Hide Outcome Measure Data
Hide Analysis Population Description
All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where death is an event, with censoring for non-expired patients at greater of off-study date or last known alive date.
Arm/Group Title Treatment Arm
Hide Arm/Group Description:

Either docetaxel or pemetrexed given with celecoxib

celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.

Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle

pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.

laboratory biomarker analysis: Blood collection

Overall Number of Participants Analyzed 23
Median (95% Confidence Interval)
Unit of Measure: days
184
(129 to 208)
2.Secondary Outcome
Title Overall Response Rate
Hide Description Overall response rate is measured by complete response + partial response. Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.
Time Frame On-treatment date to date of disease progression (assessed at 6 weeks up to 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is not evaluable for best overall response.
Arm/Group Title Treatment Arm
Hide Arm/Group Description:

Either docetaxel or pemetrexed given with celecoxib

celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.

Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle

pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.

laboratory biomarker analysis: Blood collection

Overall Number of Participants Analyzed 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
0
(0 to 0.176)
3.Secondary Outcome
Title Time to Progression
Hide Description Estimated probable duration from on-study date to date of disease progression, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.
Time Frame 2 years from date of registration
Hide Outcome Measure Data
Hide Analysis Population Description
All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where progression is an event, with censoring for non-progressed patients at greater of off-study date, last known alive date, or date of death not attributable to disease progression.
Arm/Group Title Treatment Arm
Hide Arm/Group Description:

Either docetaxel or pemetrexed given with celecoxib

celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.

Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle

pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.

laboratory biomarker analysis: Blood collection

Overall Number of Participants Analyzed 23
Median (95% Confidence Interval)
Unit of Measure: days
89
(42 to 386)
4.Other Pre-specified Outcome
Title Effect of Celecoxib on Urinary Metabolites of PGE2, PG12 and Thromboxane
Hide Description [Not Specified]
Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
data is not available. no analysis done
Arm/Group Title Treatment Arm
Hide Arm/Group Description:

Either docetaxel or pemetrexed given with celecoxib

celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.

Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle

pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.

laboratory biomarker analysis: Blood collection

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Other Pre-specified Outcome
Title Changes in Urinary PGE-M and Survival as Assessed by Immunohistochemistry
Hide Description [Not Specified]
Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
data is not available. no analysis done
Arm/Group Title Treatment Arm
Hide Arm/Group Description:

Either docetaxel or pemetrexed given with celecoxib

celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.

Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle

pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.

laboratory biomarker analysis: Blood collection

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Arm
Hide Arm/Group Description

Either docetaxel or pemetrexed given with celecoxib

celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.

Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle

pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.

laboratory biomarker analysis: Blood collection

All-Cause Mortality
Treatment Arm
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Treatment Arm
Affected / at Risk (%) # Events
Total   17/23 (73.91%)    
Blood and lymphatic system disorders   
Hemoglobin  1/23 (4.35%)  1
Cardiac disorders   
Atrial fibrillation  2/23 (8.70%)  2
Pericardial effusion (non-malignant)  1/23 (4.35%)  1
syncope  1/23 (4.35%)  1
Eye disorders   
double vision  1/23 (4.35%)  1
Gastrointestinal disorders   
Pain abdomen  1/23 (4.35%)  1
Hemorrhage, lower GI  1/23 (4.35%)  1
Obstruction - small bowel  1/23 (4.35%)  1
Perforation  1/23 (4.35%)  1
Nausea  2/23 (8.70%)  2
Gastritis  1/23 (4.35%)  1
Vomiting  2/23 (8.70%)  2
Constipation  2/23 (8.70%)  2
General disorders   
pain pleura  1/23 (4.35%)  1
Fever (in the absence of neutropenia)  1/23 (4.35%)  1
fatigue  1/23 (4.35%)  1
death  3/23 (13.04%)  3
Infections and infestations   
pneumonia, normal ANC  3/23 (13.04%)  5
Metabolism and nutrition disorders   
hypercalcemia  1/23 (4.35%)  1
Musculoskeletal and connective tissue disorders   
back pain  2/23 (8.70%)  2
Musculoskeletal/Soft Tissue  1/23 (4.35%)  1
Nervous system disorders   
Neuropathy  1/23 (4.35%)  1
Psychiatric disorders   
confusion  1/23 (4.35%)  1
Respiratory, thoracic and mediastinal disorders   
Hypoxia  1/23 (4.35%)  1
allergy  1/23 (4.35%)  1
cough  1/23 (4.35%)  1
dyspnea  1/23 (4.35%)  1
Vascular disorders   
Hypotension  1/23 (4.35%)  1
Thrombosis  1/23 (4.35%)  1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Arm
Affected / at Risk (%) # Events
Total   21/23 (91.30%)    
Blood and lymphatic system disorders   
hemoglobin  13/23 (56.52%)  22
edema - head and neck  2/23 (8.70%)  2
edema - limb  2/23 (8.70%)  2
Cardiac disorders   
fibrillation  2/23 (8.70%)  3
Gastrointestinal disorders   
nausea  5/23 (21.74%)  6
vomiting  5/23 (21.74%)  5
constipation  3/23 (13.04%)  3
dyspepsia  3/23 (13.04%)  3
anorexia  2/23 (8.70%)  2
gastrointestinal other  2/23 (8.70%)  4
dysgeusia (taste alteration)  2/23 (8.70%)  2
General disorders   
pain - thorax  3/23 (13.04%)  3
pain - NOS  2/23 (8.70%)  2
fatigue  7/23 (30.43%)  15
Metabolism and nutrition disorders   
hyperglycemia  11/23 (47.83%)  21
hyponatremia  4/23 (17.39%)  7
hypoalbuminemia  3/23 (13.04%)  5
ALG, SGPT  2/23 (8.70%)  2
AST, SGOT  2/23 (8.70%)  3
hypoglycemia  2/23 (8.70%)  2
hemoglobinuria  2/23 (8.70%)  2
Musculoskeletal and connective tissue disorders   
pain - back  2/23 (8.70%)  2
pain - joint  2/23 (8.70%)  4
Nervous system disorders   
pain - headache  3/23 (13.04%)  3
dizziness  5/23 (21.74%)  6
Respiratory, thoracic and mediastinal disorders   
dyspnea  5/23 (21.74%)  7
cough  2/23 (8.70%)  3
pulmonary upper  2/23 (8.70%)  2
dysarthria  2/23 (8.70%)  2
Skin and subcutaneous tissue disorders   
pruritus  2/23 (8.70%)  2
Vascular disorders   
thrombosis  2/23 (8.70%)  2
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: Dr. Leora Horn
Organization: Vanderbilt-Ingram Cancer Center
Phone: 615-322-4967
EMail: leora.horn@vanderbilt.edu
Layout table for additonal information
Responsible Party: Leora Horn, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00520845    
Other Study ID Numbers: VICC THO 0730
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-THO-0730
VU-VICC-IRB-070723
First Submitted: August 24, 2007
First Posted: August 27, 2007
Results First Submitted: October 5, 2014
Results First Posted: October 9, 2014
Last Update Posted: March 20, 2017