Trial Outcomes & Findings for Pemetrexed Disodium and Cisplatin in Treating Patients Who Are Undergoing Surgery for Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer (NCT NCT00248495)

NCT ID: NCT00248495

Last Updated: 2017-07-12

Results Overview

Pathologic Complete Response is defined by a surgical pathology specimen, which is free of all gross and microscopic evidence of viable tumor.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 38 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2017-07-12

Participant Flow

Participant milestones

Measure	Neoadjuvant Chemotherapy Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses cisplatin: Given IV pemetrexed disodium: Given IV adjuvant therapy: Metastasis prevention/control conventional surgery: Undergoing tissue removal neoadjuvant therapy: Tumor Reduction
Overall Study STARTED	38
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Neoadjuvant Chemotherapy Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses cisplatin: Given IV pemetrexed disodium: Given IV adjuvant therapy: Metastasis prevention/control conventional surgery: Undergoing tissue removal neoadjuvant therapy: Tumor Reduction
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Pemetrexed Disodium and Cisplatin in Treating Patients Who Are Undergoing Surgery for Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Neoadjuvant Chemotherapy n=38 Participants Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses cisplatin: Given IV pemetrexed disodium: Given IV adjuvant therapy: Metastasis prevention/control conventional surgery: Undergoing tissue removal neoadjuvant therapy: Tumor Reduction
Age, Continuous	60.8 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: ll treated and eligible patients

Pathologic Complete Response is defined by a surgical pathology specimen, which is free of all gross and microscopic evidence of viable tumor.

Outcome measures

Measure	Neoadjuvant Chemotherapy n=38 Participants Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses cisplatin: Given IV pemetrexed disodium: Given IV adjuvant therapy: Metastasis prevention/control conventional surgery: Undergoing tissue removal neoadjuvant therapy: Tumor Reduction
Pathologically Complete Response	0 percentage of participants Interval 0.0 to 9.2

SECONDARY outcome

Timeframe: 1 year

Population: All treated and eligible patients

Frequency of Adverse Events, Graded According to NCI CTCAE v3.0. Please refer to the adverse event reporting for more detail.

Outcome measures

Measure	Neoadjuvant Chemotherapy n=38 Participants Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses cisplatin: Given IV pemetrexed disodium: Given IV adjuvant therapy: Metastasis prevention/control conventional surgery: Undergoing tissue removal neoadjuvant therapy: Tumor Reduction
Number of Participants With Adverse Events Grade 1	2 Participants
Number of Participants With Adverse Events Grade 2	13 Participants
Number of Participants With Adverse Events Grade 3	19 Participants
Number of Participants With Adverse Events Grade 4	4 Participants

SECONDARY outcome

Timeframe: Every 6 months until the time of death up to 126 months

Population: All treated and eligible patients

Overall survival was defined as time from date of treatment initiation until date of death due to any cause.

Outcome measures

Measure	Neoadjuvant Chemotherapy n=38 Participants Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses cisplatin: Given IV pemetrexed disodium: Given IV adjuvant therapy: Metastasis prevention/control conventional surgery: Undergoing tissue removal neoadjuvant therapy: Tumor Reduction
Overall Survival	100.7 months Interval 37.0 to 126.0

SECONDARY outcome

Timeframe: At least every 3 months after the completion of adjuvant therapy for two years and thereafter every 6 months for 3 years and then yearly up to 126 months

Population: All treated and eligible patients

Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesions. Disease Free Survival was defined as time from date of treatment initiation until date of first documented progression or date of death from any cause, whichever came first.

Outcome measures

Measure	Neoadjuvant Chemotherapy n=38 Participants Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses cisplatin: Given IV pemetrexed disodium: Given IV adjuvant therapy: Metastasis prevention/control conventional surgery: Undergoing tissue removal neoadjuvant therapy: Tumor Reduction
Disease Free Survival	34.5 months Interval 14.7 to 126.0

SECONDARY outcome

Timeframe: 1 year

Population: No participants were analyzed as there was no budget left to do the analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and post-chemotherapy

Population: All treated and eligible patients

Percent change of PET/SUV levels between baseline and post-chemotherapy.

Outcome measures

Measure	Neoadjuvant Chemotherapy n=38 Participants Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses cisplatin: Given IV pemetrexed disodium: Given IV adjuvant therapy: Metastasis prevention/control conventional surgery: Undergoing tissue removal neoadjuvant therapy: Tumor Reduction
Percent Change in SUV Level Between Pre and Post Chemotherapy	-36.1 Percentage change in SUV level Standard Deviation 40.6

Adverse Events

Neoadjuvant Chemotherapy

Serious events: 14 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Measure	Neoadjuvant Chemotherapy n=38 participants at risk Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses cisplatin: Given IV pemetrexed disodium: Given IV adjuvant therapy: Metastasis prevention/control conventional surgery: Undergoing tissue removal neoadjuvant therapy: Tumor Reduction
Blood and lymphatic system disorders Anaemia	2.6% 1/38 • Number of events 1
Cardiac disorders Pericarditis	2.6% 1/38 • Number of events 2
Gastrointestinal disorders Abdominal pain	2.6% 1/38 • Number of events 1
Gastrointestinal disorders Diarrhoea	2.6% 1/38 • Number of events 1
General disorders Chest pain	2.6% 1/38 • Number of events 1
General disorders Pyrexia	2.6% 1/38 • Number of events 1
Infections and infestations Cellulitis	2.6% 1/38 • Number of events 1
Infections and infestations Empyema	2.6% 1/38 • Number of events 1
Infections and infestations Infection	2.6% 1/38 • Number of events 1
Infections and infestations Pneumonia	2.6% 1/38 • Number of events 1
Injury, poisoning and procedural complications Spinal fracture	2.6% 1/38 • Number of events 1
Investigations Blood creatine phosphokinase increased	2.6% 1/38 • Number of events 1
Metabolism and nutrition disorders Hyperglycaemia	2.6% 1/38 • Number of events 1
Nervous system disorders Ischaemic stroke	2.6% 1/38 • Number of events 1
Respiratory, thoracic and mediastinal disorders Bronchopleural fistula	2.6% 1/38 • Number of events 1
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.6% 1/38 • Number of events 1
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.3% 2/38 • Number of events 2
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	2.6% 1/38 • Number of events 1
Respiratory, thoracic and mediastinal disorders Tachypnoea	2.6% 1/38 • Number of events 1
Skin and subcutaneous tissue disorders Subcutaneous emphysema	2.6% 1/38 • Number of events 1
Vascular disorders Arterial thrombosis	2.6% 1/38 • Number of events 1
Vascular disorders Deep vein thrombosis	2.6% 1/38 • Number of events 1
Vascular disorders Thrombosis	2.6% 1/38 • Number of events 1

Other adverse events

Measure	Neoadjuvant Chemotherapy n=38 participants at risk Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses cisplatin: Given IV pemetrexed disodium: Given IV adjuvant therapy: Metastasis prevention/control conventional surgery: Undergoing tissue removal neoadjuvant therapy: Tumor Reduction
Blood and lymphatic system disorders Anaemia	50.0% 19/38 • Number of events 22
Blood and lymphatic system disorders Leukopenia	31.6% 12/38 • Number of events 18
Blood and lymphatic system disorders Lymphopenia	2.6% 1/38 • Number of events 1
Blood and lymphatic system disorders Neutropenia	26.3% 10/38 • Number of events 13
Blood and lymphatic system disorders Thrombocytopenia	13.2% 5/38 • Number of events 7
Cardiac disorders Atrial fibrillation	5.3% 2/38 • Number of events 2
Cardiac disorders Tachycardia	5.3% 2/38 • Number of events 2
Ear and labyrinth disorders Ear congestion	2.6% 1/38 • Number of events 1
Ear and labyrinth disorders Tinnitus	26.3% 10/38 • Number of events 11
Eye disorders Dry eye	2.6% 1/38 • Number of events 1
Eye disorders Eye discharge	2.6% 1/38 • Number of events 1
Eye disorders Eye irritation	2.6% 1/38 • Number of events 1
Eye disorders Lacrimation increased	2.6% 1/38 • Number of events 1
Eye disorders Vision blurred	2.6% 1/38 • Number of events 1
Gastrointestinal disorders Abdominal discomfort	2.6% 1/38 • Number of events 1
Gastrointestinal disorders Abdominal pain	7.9% 3/38 • Number of events 3
Gastrointestinal disorders Constipation	21.1% 8/38 • Number of events 8
Gastrointestinal disorders Diarrhoea	31.6% 12/38 • Number of events 15
Gastrointestinal disorders Dyspepsia	7.9% 3/38 • Number of events 3
Gastrointestinal disorders Ileus paralytic	2.6% 1/38 • Number of events 1
Gastrointestinal disorders Lip pain	2.6% 1/38 • Number of events 1
Gastrointestinal disorders Mouth ulceration	2.6% 1/38 • Number of events 1
Gastrointestinal disorders Nausea	60.5% 23/38 • Number of events 33
Gastrointestinal disorders Reflux gastritis	2.6% 1/38 • Number of events 1
Gastrointestinal disorders Reflux oesophagitis	2.6% 1/38 • Number of events 1
Gastrointestinal disorders Stomatitis	10.5% 4/38 • Number of events 5
Gastrointestinal disorders Vomiting	21.1% 8/38 • Number of events 8
General disorders Asthenia	7.9% 3/38 • Number of events 3
General disorders Chest discomfort	2.6% 1/38 • Number of events 1
General disorders Chest pain	7.9% 3/38 • Number of events 3
General disorders Chills	2.6% 1/38 • Number of events 1
General disorders Fatigue	65.8% 25/38 • Number of events 35
General disorders Feeling jittery	2.6% 1/38 • Number of events 1
General disorders Influenza like illness	7.9% 3/38 • Number of events 3
General disorders Injection site swelling	2.6% 1/38 • Number of events 1
General disorders Non-cardiac chest pain	10.5% 4/38 • Number of events 4
General disorders Pain	7.9% 3/38 • Number of events 4
General disorders Pyrexia	2.6% 1/38 • Number of events 1
Infections and infestations Candidiasis	2.6% 1/38 • Number of events 1
Infections and infestations Influenza	5.3% 2/38 • Number of events 2
Infections and infestations Nasopharyngitis	13.2% 5/38 • Number of events 5
Infections and infestations Sinusitis	5.3% 2/38 • Number of events 2
Infections and infestations Upper respiratory tract infection	7.9% 3/38 • Number of events 3
Injury, poisoning and procedural complications Contusion	2.6% 1/38 • Number of events 1
Injury, poisoning and procedural complications Incision site pain	2.6% 1/38 • Number of events 1
Injury, poisoning and procedural complications Procedural pain	2.6% 1/38 • Number of events 1
Injury, poisoning and procedural complications Suture related complication	2.6% 1/38 • Number of events 1
Investigations Alanine aminotransferase increased	2.6% 1/38 • Number of events 1
Investigations Aspartate aminotransferase increased	10.5% 4/38 • Number of events 4
Investigations Blood alkaline phosphatase increased	13.2% 5/38 • Number of events 5
Investigations Haemoglobin	2.6% 1/38 • Number of events 1
Metabolism and nutrition disorders Decreased appetite	21.1% 8/38 • Number of events 8
Metabolism and nutrition disorders Dehydration	2.6% 1/38 • Number of events 1
Metabolism and nutrition disorders Hypercalcaemia	2.6% 1/38 • Number of events 1
Metabolism and nutrition disorders Hyperglycaemia	52.6% 20/38 • Number of events 41
Metabolism and nutrition disorders Hyperkalaemia	23.7% 9/38 • Number of events 12
Metabolism and nutrition disorders Hypernatraemia	2.6% 1/38 • Number of events 1
Metabolism and nutrition disorders Hypoalbuminaemia	5.3% 2/38 • Number of events 2
Metabolism and nutrition disorders Hypocalcaemia	2.6% 1/38 • Number of events 1
Metabolism and nutrition disorders Hyponatraemia	7.9% 3/38 • Number of events 3
Musculoskeletal and connective tissue disorders Back pain	13.2% 5/38 • Number of events 5
Musculoskeletal and connective tissue disorders Muscle spasms	2.6% 1/38 • Number of events 1
Musculoskeletal and connective tissue disorders Muscular weakness	5.3% 2/38 • Number of events 2
Musculoskeletal and connective tissue disorders Neck pain	2.6% 1/38 • Number of events 1
Musculoskeletal and connective tissue disorders Pain in extremity	2.6% 1/38 • Number of events 1
Nervous system disorders Balance disorder	2.6% 1/38 • Number of events 1
Nervous system disorders Dizziness	7.9% 3/38 • Number of events 4
Nervous system disorders Dysgeusia	7.9% 3/38 • Number of events 3
Nervous system disorders Headache	10.5% 4/38 • Number of events 5
Nervous system disorders Hypoaesthesia	7.9% 3/38 • Number of events 3
Nervous system disorders Neuropathy peripheral	7.9% 3/38 • Number of events 3
Nervous system disorders Peripheral sensory neuropathy	2.6% 1/38 • Number of events 1
Nervous system disorders Somnolence	2.6% 1/38 • Number of events 1
Nervous system disorders Syncope	2.6% 1/38 • Number of events 1
Nervous system disorders Vocal cord paresis	2.6% 1/38 • Number of events 1
Psychiatric disorders Anxiety	5.3% 2/38 • Number of events 2
Psychiatric disorders Depression	2.6% 1/38 • Number of events 1
Psychiatric disorders Insomnia	13.2% 5/38 • Number of events 5
Psychiatric disorders Panic attack	2.6% 1/38 • Number of events 1
Renal and urinary disorders Dysuria	5.3% 2/38 • Number of events 2
Respiratory, thoracic and mediastinal disorders Cough	34.2% 13/38 • Number of events 13
Respiratory, thoracic and mediastinal disorders Dysphonia	2.6% 1/38 • Number of events 1
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.5% 4/38 • Number of events 4
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	15.8% 6/38 • Number of events 7
Respiratory, thoracic and mediastinal disorders Epistaxis	2.6% 1/38 • Number of events 1
Respiratory, thoracic and mediastinal disorders Hiccups	2.6% 1/38 • Number of events 1
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.9% 3/38 • Number of events 3
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.3% 2/38 • Number of events 2
Respiratory, thoracic and mediastinal disorders Sinus congestion	5.3% 2/38 • Number of events 2
Respiratory, thoracic and mediastinal disorders Sinusitis noninfective	2.6% 1/38 • Number of events 1
Respiratory, thoracic and mediastinal disorders Upper respiratory tract congestion	2.6% 1/38 • Number of events 1
Respiratory, thoracic and mediastinal disorders Wheezing	2.6% 1/38 • Number of events 2
Skin and subcutaneous tissue disorders Dry skin	2.6% 1/38 • Number of events 1
Skin and subcutaneous tissue disorders Erythema	5.3% 2/38 • Number of events 2
Skin and subcutaneous tissue disorders Rash	7.9% 3/38 • Number of events 3
Skin and subcutaneous tissue disorders Skin hyperpigmentation	2.6% 1/38 • Number of events 1
Vascular disorders Flushing	2.6% 1/38 • Number of events 1
Vascular disorders Hot flush	2.6% 1/38 • Number of events 1
Vascular disorders Hypertension	2.6% 1/38 • Number of events 1
Vascular disorders Phlebitis	2.6% 1/38 • Number of events 1

Additional Information

Senior Administrator, Compliance - Clinical Research Services

Roswell Park Cancer Institute

Phone: 716-845-2300

Results disclosure agreements

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