Trial Outcomes & Findings for Celecoxib and Docetaxel or Pemetrexed in Treating Patients With Advanced Recurrent Non-Small Cell Lung Cancer (NCT NCT00520845)

NCT ID: NCT00520845

Last Updated: 2017-03-20

Results Overview

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)

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 23 participants
• Primary outcome timeframe: 2 years from date of registration
• Results posted on: 2017-03-20

Participant Flow

This study opened October 2007 and ran to December 2013. All patients were recruited from Vanderbilt-Ingram Cancer Center.

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.

Participant milestones

Measure	Treatment Arm 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 Study STARTED	23
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Measure	Treatment Arm 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 Study Death	3
Overall Study Adverse Event	4
Overall Study Disease Progression, relapse	13
Overall Study Withdrawal by Subject	1
Overall Study Alternative Therapy	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Treatment Arm n=23 Participants 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
Age, Continuous	63.26 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years from date of registration

Population: 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.

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)

Outcome measures

Measure

Treatment Arm n=23 Participants 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

Median Survival

184 days Interval 129.0 to 208.0

SECONDARY outcome

Timeframe: On-treatment date to date of disease progression (assessed at 6 weeks up to 2 years)

Population: 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.

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.

Outcome measures

Measure

Treatment Arm n=19 Participants 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 Response Rate

0 participants Interval 0.0 to 0.176

SECONDARY outcome

Timeframe: 2 years from date of registration

Population: 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.

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.

Outcome measures

Measure

Treatment Arm n=23 Participants 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

Time to Progression

89 days Interval 42.0 to 386.0

OTHER_PRE_SPECIFIED outcome

Timeframe: At 1 year

Population: data is not available. no analysis done

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At 1 year

Population: data is not available. no analysis done

Outcome measures

Outcome data not reported

Adverse Events

Treatment Arm

Serious events: 17 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Arm n=23 participants at risk 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
Infections and infestations pneumonia, normal ANC	13.0% 3/23 • Number of events 5
Musculoskeletal and connective tissue disorders back pain	8.7% 2/23 • Number of events 2
Gastrointestinal disorders Pain abdomen	4.3% 1/23 • Number of events 1
General disorders pain pleura	4.3% 1/23 • Number of events 1
Respiratory, thoracic and mediastinal disorders Hypoxia	4.3% 1/23 • Number of events 1
Vascular disorders Hypotension	4.3% 1/23 • Number of events 1
Gastrointestinal disorders Hemorrhage, lower GI	4.3% 1/23 • Number of events 1
Gastrointestinal disorders Obstruction - small bowel	4.3% 1/23 • Number of events 1
Respiratory, thoracic and mediastinal disorders allergy	4.3% 1/23 • Number of events 1
Psychiatric disorders confusion	4.3% 1/23 • Number of events 1
Nervous system disorders Neuropathy	4.3% 1/23 • Number of events 1
General disorders Fever (in the absence of neutropenia)	4.3% 1/23 • Number of events 1
Cardiac disorders Atrial fibrillation	8.7% 2/23 • Number of events 2
Blood and lymphatic system disorders Hemoglobin	4.3% 1/23 • Number of events 1
Cardiac disorders Pericardial effusion (non-malignant)	4.3% 1/23 • Number of events 1
Gastrointestinal disorders Perforation	4.3% 1/23 • Number of events 1
Cardiac disorders syncope	4.3% 1/23 • Number of events 1
Gastrointestinal disorders Nausea	8.7% 2/23 • Number of events 2
Gastrointestinal disorders Gastritis	4.3% 1/23 • Number of events 1
Gastrointestinal disorders Vomiting	8.7% 2/23 • Number of events 2
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue	4.3% 1/23 • Number of events 1
Eye disorders double vision	4.3% 1/23 • Number of events 1
Metabolism and nutrition disorders hypercalcemia	4.3% 1/23 • Number of events 1
Vascular disorders Thrombosis	4.3% 1/23 • Number of events 1
Gastrointestinal disorders Constipation	8.7% 2/23 • Number of events 2
Respiratory, thoracic and mediastinal disorders cough	4.3% 1/23 • Number of events 1
Respiratory, thoracic and mediastinal disorders dyspnea	4.3% 1/23 • Number of events 1
General disorders fatigue	4.3% 1/23 • Number of events 1
General disorders death	13.0% 3/23 • Number of events 3

Other adverse events

Measure	Treatment Arm n=23 participants at risk 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
Metabolism and nutrition disorders hyperglycemia	47.8% 11/23 • Number of events 21
Metabolism and nutrition disorders hyponatremia	17.4% 4/23 • Number of events 7
Metabolism and nutrition disorders hypoalbuminemia	13.0% 3/23 • Number of events 5
Metabolism and nutrition disorders ALG, SGPT	8.7% 2/23 • Number of events 2
Metabolism and nutrition disorders AST, SGOT	8.7% 2/23 • Number of events 3
Metabolism and nutrition disorders hypoglycemia	8.7% 2/23 • Number of events 2
Metabolism and nutrition disorders hemoglobinuria	8.7% 2/23 • Number of events 2
Blood and lymphatic system disorders hemoglobin	56.5% 13/23 • Number of events 22
Gastrointestinal disorders nausea	21.7% 5/23 • Number of events 6
Gastrointestinal disorders vomiting	21.7% 5/23 • Number of events 5
Gastrointestinal disorders constipation	13.0% 3/23 • Number of events 3
Gastrointestinal disorders dyspepsia	13.0% 3/23 • Number of events 3
Gastrointestinal disorders anorexia	8.7% 2/23 • Number of events 2
Gastrointestinal disorders gastrointestinal other	8.7% 2/23 • Number of events 4
Gastrointestinal disorders dysgeusia (taste alteration)	8.7% 2/23 • Number of events 2
General disorders pain - thorax	13.0% 3/23 • Number of events 3
Nervous system disorders pain - headache	13.0% 3/23 • Number of events 3
Musculoskeletal and connective tissue disorders pain - back	8.7% 2/23 • Number of events 2
Musculoskeletal and connective tissue disorders pain - joint	8.7% 2/23 • Number of events 4
General disorders pain - NOS	8.7% 2/23 • Number of events 2
Respiratory, thoracic and mediastinal disorders dyspnea	21.7% 5/23 • Number of events 7
Respiratory, thoracic and mediastinal disorders cough	8.7% 2/23 • Number of events 3
Respiratory, thoracic and mediastinal disorders pulmonary upper	8.7% 2/23 • Number of events 2
Respiratory, thoracic and mediastinal disorders dysarthria	8.7% 2/23 • Number of events 2
General disorders fatigue	30.4% 7/23 • Number of events 15
Nervous system disorders dizziness	21.7% 5/23 • Number of events 6
Skin and subcutaneous tissue disorders pruritus	8.7% 2/23 • Number of events 2
Blood and lymphatic system disorders edema - head and neck	8.7% 2/23 • Number of events 2
Blood and lymphatic system disorders edema - limb	8.7% 2/23 • Number of events 2
Cardiac disorders fibrillation	8.7% 2/23 • Number of events 3
Vascular disorders thrombosis	8.7% 2/23 • Number of events 2

Additional Information

Dr. Leora Horn

Vanderbilt-Ingram Cancer Center

Phone: 615-322-4967

Email: leora.horn@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place