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Carboplatin, Paclitaxel, Selenomethionine, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

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ClinicalTrials.gov Identifier: NCT00526890
Recruitment Status : Terminated (lack of efficacy)
First Posted : September 10, 2007
Results First Posted : January 15, 2015
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Dietary Supplement: selenomethionine
Drug: carboplatin
Drug: paclitaxel
Other: laboratory biomarker analysis
Radiation: radiation therapy
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CPSR
Hide Arm/Group Description Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
Period Title: Overall Study
Started 16
Completed 14
Not Completed 2
Reason Not Completed
Adverse Event             2
Arm/Group Title CPSR
Hide Arm/Group Description Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
63.25  (9.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
11
  68.8%
Male
5
  31.3%
1.Primary Outcome
Title Incidence of Grade 3-4 Esophagitis
Hide Description [Not Specified]
Time Frame During study treatment, up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Treated with Study Therapy
Arm/Group Title CPSR
Hide Arm/Group Description:
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
Overall Number of Participants Analyzed 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
18.75
(4.05 to 45.65)
2.Primary Outcome
Title Incidence of Grade 3-4 Pneumonitis
Hide Description [Not Specified]
Time Frame During study treatment, up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients treated with study therapy
Arm/Group Title CPSR
Hide Arm/Group Description:
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
Overall Number of Participants Analyzed 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 20.59)
3.Primary Outcome
Title Incidence of Grade 3-4 Myelosuppression
Hide Description [Not Specified]
Time Frame During study treatment, up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients Treated with Study Therapy
Arm/Group Title CPSR
Hide Arm/Group Description:
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
Overall Number of Participants Analyzed 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.50
(1.55 to 38.35)
4.Secondary Outcome
Title Response Rate
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame 1 month post-treatment, then q 3 months x 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CPSR
Hide Arm/Group Description:
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
Overall Number of Participants Analyzed 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
50
(24.65 to 75.35)
5.Secondary Outcome
Title Failure-free Survival
Hide Description [Not Specified]
Time Frame Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients treated with study therapy
Arm/Group Title CPSR
Hide Arm/Group Description:
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
Overall Number of Participants Analyzed 16
Median (95% Confidence Interval)
Unit of Measure: months
9.0
(3.3 to 21.5)
6.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter
Hide Outcome Measure Data
Hide Analysis Population Description
Patients treated with study therapy
Arm/Group Title CPSR
Hide Arm/Group Description:
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
Overall Number of Participants Analyzed 16
Median (95% Confidence Interval)
Unit of Measure: months
14.5 [1] 
(7.5 to NA)
[1]
NA (not available): the upper bound of the 95% CI was not reached but is >36.4 months
7.Secondary Outcome
Title Selenium Level by Incidence of SAE
Hide Description Median Selenium level by Incidence of SAE. Mann-Whitney-Wilcoxon test was used to test the correlation between selenium levels and serious adverse events.
Time Frame Pre-treatment and every week for 6 weeks prior to chemotherapy.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title CPSR
Hide Arm/Group Description:
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
Overall Number of Participants Analyzed 16
Median (Full Range)
Unit of Measure: ng/mL
No SAE
1435.0
(847.9 to 2870.3)
SAE
1803.6
(1465.0 to 2039.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CPSR
Comments Mann-Whitney-Wilcoxon test was used to test the correlation between selenium levels and serious adverse events.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3149
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CPSR
Hide Arm/Group Description Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
All-Cause Mortality
CPSR
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CPSR
Affected / at Risk (%) # Events
Total   4/16 (25.00%)    
Cardiac disorders   
Atrial fibrillation - Grade 2   1/16 (6.25%)  1
Gastrointestinal disorders   
Oesophagitis - Grade 3   1/16 (6.25%)  1
Infections and infestations   
Urinary tract infection - Grade 3   1/16 (6.25%)  1
Metabolism and nutrition disorders   
Hypokalaemia - Grade 4   1/16 (6.25%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CPSR
Affected / at Risk (%) # Events
Total   16/16 (100.00%)    
Blood and lymphatic system disorders   
Anaemia - Grade 1   7/16 (43.75%)  9
Anaemia - Grade 2   4/16 (25.00%)  5
Anaemia - Grade 3   1/16 (6.25%)  1
Leukopenia - Grade 1   8/16 (50.00%)  8
Leukopenia - Grade 2   6/16 (37.50%)  6
Leukopenia - Grade 3   2/16 (12.50%)  2
Neutropenia - Grade 1   3/16 (18.75%)  3
Neutropenia - Grade 2   2/16 (12.50%)  2
Thrombocytopenia - Grade 1   2/16 (12.50%)  2
Cardiac disorders   
Arrhythmia - Grade 1   1/16 (6.25%)  1
Tachycardia - Grade 1   2/16 (12.50%)  2
Ear and labyrinth disorders   
Ear pain - Grade 2   1/16 (6.25%)  1
Gastrointestinal disorders   
Abdominal pain - Grade 1   1/16 (6.25%)  1
Abdominal pain - Grade 2   1/16 (6.25%)  1
Breath odour - Grade 1   1/16 (6.25%)  1
Chapped lips - Grade 1   1/16 (6.25%)  1
Constipation - Grade 1   5/16 (31.25%)  6
Constipation - Grade 2   2/16 (12.50%)  2
Diarrhoea - Grade 1   1/16 (6.25%)  1
Diarrhoea - Grade 2   1/16 (6.25%)  1
Dyspepsia - Grade 1   2/16 (12.50%)  2
Dyspepsia - Grade 2   1/16 (6.25%)  1
Dysphagia - Grade 1   1/16 (6.25%)  1
Nausea - Grade 1   2/16 (12.50%)  2
Nausea - Grade 2   1/16 (6.25%)  1
Oesophageal pain - Grade 2   1/16 (6.25%)  1
Oesophagitis - Grade 1   5/16 (31.25%)  6
Oesophagitis - Grade 2   9/16 (56.25%)  10
Oesophagitis - Grade 3   2/16 (12.50%)  2
Stomatitis - Grade 3   1/16 (6.25%)  1
General disorders   
Chest pain - Grade 1   1/16 (6.25%)  1
Fatigue - Grade 1   6/16 (37.50%)  7
Fatigue - Grade 2   3/16 (18.75%)  4
Fatigue - Grade 3   1/16 (6.25%)  1
Mucosal inflammation - Grade 2   1/16 (6.25%)  1
Oedema peripheral - Grade 1   1/16 (6.25%)  1
Oedema peripheral - Grade 2   1/16 (6.25%)  1
Pain - Grade 1   1/16 (6.25%)  1
Pain - Grade 2   2/16 (12.50%)  2
Pyrexia - Grade 1   1/16 (6.25%)  3
Infections and infestations   
Bacterial infection - Grade 2   1/16 (6.25%)  1
Herpes zoster - Grade 2   1/16 (6.25%)  1
Infection - Grade 2   1/16 (6.25%)  1
Lower respiratory tract infection - Grade 1   1/16 (6.25%)  1
Lower respiratory tract infection - Grade 2   1/16 (6.25%)  1
Urinary tract infection - Grade 1   1/16 (6.25%)  1
Urinary tract infection - Grade 2   1/16 (6.25%)  1
Injury, poisoning and procedural complications   
Contusion - Grade 1   1/16 (6.25%)  1
Radiation pneumonitis - Grade 1   1/16 (6.25%)  1
Radiation pneumonitis - Grade 2   3/16 (18.75%)  3
Radiation skin injury - Grade 1   1/16 (6.25%)  1
Radiation skin injury - Grade 2   1/16 (6.25%)  1
Thermal burn - Grade 1   2/16 (12.50%)  2
Investigations   
Blood alkaline phosphatase increased - Grade 1   1/16 (6.25%)  1
Weight decreased - Grade 1   1/16 (6.25%)  1
Weight decreased - Grade 2   1/16 (6.25%)  1
Metabolism and nutrition disorders   
Anorexia - Grade 2   2/16 (12.50%)  2
Decreased appetite - Grade 1   1/16 (6.25%)  1
Dehydration - Grade 3   1/16 (6.25%)  1
Hypercholesterolaemia - Grade 1   1/16 (6.25%)  1
Hyperglycaemia - Grade 1   7/16 (43.75%)  10
Hyperglycaemia - Grade 2   5/16 (31.25%)  7
Hyperglycaemia - Grade 3   6/16 (37.50%)  6
Hyperkalaemia - Grade 1   2/16 (12.50%)  2
Hypernatraemia - Grade 1   1/16 (6.25%)  1
Hypertriglyceridaemia - Grade 1   1/16 (6.25%)  1
Hypoalbuminaemia - Grade 1   1/16 (6.25%)  1
Hypoalbuminaemia - Grade 2   1/16 (6.25%)  1
Hypocalcaemia - Grade 2   1/16 (6.25%)  1
Hypokalaemia - Grade 1   4/16 (25.00%)  4
Hypokalaemia - Grade 3   1/16 (6.25%)  1
Hypomagnesaemia - Grade 1   2/16 (12.50%)  2
Hyponatraemia - Grade 1   4/16 (25.00%)  4
Musculoskeletal and connective tissue disorders   
Arthralgia - Grade 2   1/16 (6.25%)  1
Back pain - Grade 1   1/16 (6.25%)  1
Limb discomfort - Grade 1   1/16 (6.25%)  1
Muscular weakness - Grade 2   1/16 (6.25%)  1
Musculoskeletal chest pain - Grade 1   1/16 (6.25%)  1
Myalgia - Grade 1   1/16 (6.25%)  1
Nervous system disorders   
Dizziness - Grade 1   1/16 (6.25%)  1
Dysgeusia - Grade 1   1/16 (6.25%)  1
Extrapyramidal disorder - Grade 2   1/16 (6.25%)  1
Headache - Grade 2   1/16 (6.25%)  1
Neuropathy peripheral - Grade 1   1/16 (6.25%)  1
Peripheral sensory neuropathy - Grade 1   1/16 (6.25%)  1
Psychiatric disorders   
Insomnia - Grade 2   1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders   
Cough - Grade 1   2/16 (12.50%)  3
Dyspnoea - Grade 2   1/16 (6.25%)  1
Haemoptysis - Grade 1   1/16 (6.25%)  1
Hypoxia - Grade 3   1/16 (6.25%)  1
Pharyngolaryngeal pain - Grade 1   1/16 (6.25%)  1
Pleural effusion - Grade 1   1/16 (6.25%)  1
Pleuritic pain - Grade 1   1/16 (6.25%)  1
Productive cough - Grade 2   1/16 (6.25%)  1
Pulmonary embolism - Grade 3   1/16 (6.25%)  1
Rhinorrhoea - Grade 1   1/16 (6.25%)  1
Skin and subcutaneous tissue disorders   
Alopecia - Grade 1   1/16 (6.25%)  1
Hyperhidrosis - Grade 1   1/16 (6.25%)  1
Night sweats - Grade 1   2/16 (12.50%)  2
Vascular disorders   
Deep vein thrombosis - Grade 3   1/16 (6.25%)  1
Hypotension - Grade 2   1/16 (6.25%)  1
Orthostatic hypotension - Grade 1   1/16 (6.25%)  1
Orthostatic hypotension - Grade 2   1/16 (6.25%)  1
Orthostatic hypotension - Grade 3   1/16 (6.25%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
Phone: 716-845-2300
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00526890     History of Changes
Other Study ID Numbers: CDR0000562780
RPCI-I-65605
First Submitted: September 7, 2007
First Posted: September 10, 2007
Results First Submitted: January 8, 2015
Results First Posted: January 15, 2015
Last Update Posted: November 28, 2017