Trial Outcomes & Findings for Effects of Carboplatin and Gemcitabine on Stage IIIB Pleural Effusion and Stage IV Lung Cancer (NCT NCT00247416)
NCT ID: NCT00247416
Last Updated: 2014-03-07
Results Overview
Reduction grade 3/4 neutropenia
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
continuous throughout treatment, up to 25 weeks
Results posted on
2014-03-07
Participant Flow
Total number of patients enrolled is 60. However, 1 patient enrolled to trial was discontinued from trial prior to receipt of any study therapies; patient was randomized to arm 1 (control, no dexamethasone pretreatment) but received no study therapies or procedures.
Participant milestones
| Measure |
Arm 1, Control, no Dexamethasone Pretreatment
Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
|
Arm 2, Dexamethasone Pretreatment Test Arm
Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
33
|
|
Overall Study
COMPLETED
|
25
|
31
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Arm 1, Control, no Dexamethasone Pretreatment
Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
|
Arm 2, Dexamethasone Pretreatment Test Arm
Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
|
|---|---|---|
|
Overall Study
3 patients were found to be ineligible
|
1
|
2
|
Baseline Characteristics
Effects of Carboplatin and Gemcitabine on Stage IIIB Pleural Effusion and Stage IV Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm 1, Control, no Dexamethasone Pretreatment
n=25 Participants
Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
|
Arm 2, Dexamethasone Pretreatment Test Arm
n=31 Participants
Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
31 participants
n=7 Participants
|
56 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: continuous throughout treatment, up to 25 weeksReduction grade 3/4 neutropenia
Outcome measures
| Measure |
1 No Dex
n=25 Participants
No Dexamethasone
Gemcitabine: Gemcitabine 1000 mg/m\^2 intravenously over 30 minutes on days 5 and 12.
Carboplatin: AUC 6.0 intravenously over 30 minutes on day 5.
|
2 Dex
n=31 Participants
Dexamethasone
Gemcitabine: Gemcitabine 1000 mg/m\^2 intravenously over 30 minutes on days 5 and 12.
Dexamethasone: 16 mg bid for 4 days prior to each chemotherapy start.
Carboplatin: AUC 6.0 intravenously over 30 minutes on day 5.
|
|---|---|---|
|
Percentage of Participants With Reduction in Grade 3/4 Neutropenia
|
40 percentage of participants
|
13 percentage of participants
|
SECONDARY outcome
Timeframe: Pre-treatment, pre-cycles 3 & 5, and up to 4 weeks after last treatmentPer 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.
Outcome measures
| Measure |
1 No Dex
n=25 Participants
No Dexamethasone
Gemcitabine: Gemcitabine 1000 mg/m\^2 intravenously over 30 minutes on days 5 and 12.
Carboplatin: AUC 6.0 intravenously over 30 minutes on day 5.
|
2 Dex
n=31 Participants
Dexamethasone
Gemcitabine: Gemcitabine 1000 mg/m\^2 intravenously over 30 minutes on days 5 and 12.
Dexamethasone: 16 mg bid for 4 days prior to each chemotherapy start.
Carboplatin: AUC 6.0 intravenously over 30 minutes on day 5.
|
|---|---|---|
|
Effect of Dexamethasone Pre-treatment on Response Rate.
|
8 percentage of responders out of total
Interval 0.1 to 26.0
|
26 percentage of responders out of total
Interval 11.9 to 44.6
|
SECONDARY outcome
Timeframe: Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, every 3 months, an average of 471 daysOverall survival
Outcome measures
| Measure |
1 No Dex
n=25 Participants
No Dexamethasone
Gemcitabine: Gemcitabine 1000 mg/m\^2 intravenously over 30 minutes on days 5 and 12.
Carboplatin: AUC 6.0 intravenously over 30 minutes on day 5.
|
2 Dex
n=31 Participants
Dexamethasone
Gemcitabine: Gemcitabine 1000 mg/m\^2 intravenously over 30 minutes on days 5 and 12.
Dexamethasone: 16 mg bid for 4 days prior to each chemotherapy start.
Carboplatin: AUC 6.0 intravenously over 30 minutes on day 5.
|
|---|---|---|
|
Effect of Dexamethasone Pre-treatment on Overall Survival.
|
291 days
Interval 228.0 to 437.0
|
378 days
Interval 189.0 to 608.0
|
SECONDARY outcome
Timeframe: Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, and every 3 months, an average of 471 daysprogression-free survival
Outcome measures
| Measure |
1 No Dex
n=25 Participants
No Dexamethasone
Gemcitabine: Gemcitabine 1000 mg/m\^2 intravenously over 30 minutes on days 5 and 12.
Carboplatin: AUC 6.0 intravenously over 30 minutes on day 5.
|
2 Dex
n=31 Participants
Dexamethasone
Gemcitabine: Gemcitabine 1000 mg/m\^2 intravenously over 30 minutes on days 5 and 12.
Dexamethasone: 16 mg bid for 4 days prior to each chemotherapy start.
Carboplatin: AUC 6.0 intravenously over 30 minutes on day 5.
|
|---|---|---|
|
Progression-free Survival
|
101 days
Interval 60.0 to 172.0
|
122 days
Interval 82.0 to 185.0
|
Adverse Events
1 No Dexamethasone
Serious events: 7 serious events
Other events: 26 other events
Deaths: 0 deaths
2 Dexamethasone
Serious events: 12 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 No Dexamethasone
n=26 participants at risk
Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
|
2 Dexamethasone
n=33 participants at risk
Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
|
|---|---|---|
|
Blood and lymphatic system disorders
ANEMIA
|
0.00%
0/26
|
3.0%
1/33
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/26
|
3.0%
1/33
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
3.8%
1/26
|
6.1%
2/33
|
|
Cardiac disorders
HEART ARREST
|
3.8%
1/26
|
3.0%
1/33
|
|
Gastrointestinal disorders
CONSTIPATION
|
7.7%
2/26
|
0.00%
0/33
|
|
Gastrointestinal disorders
DIARRHEA
|
0.00%
0/26
|
3.0%
1/33
|
|
Gastrointestinal disorders
DUODENAL ULCER
|
0.00%
0/26
|
3.0%
1/33
|
|
Gastrointestinal disorders
NAUSEA
|
3.8%
1/26
|
3.0%
1/33
|
|
Gastrointestinal disorders
RECTAL DISORDER
|
0.00%
0/26
|
3.0%
1/33
|
|
Gastrointestinal disorders
VOMITING
|
3.8%
1/26
|
0.00%
0/33
|
|
General disorders
MEDICATION ERROR
|
0.00%
0/26
|
3.0%
1/33
|
|
General disorders
SEPSIS
|
0.00%
0/26
|
9.1%
3/33
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
0.00%
0/26
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
3.8%
1/26
|
0.00%
0/33
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/26
|
3.0%
1/33
|
|
Nervous system disorders
DIZZINESS
|
3.8%
1/26
|
0.00%
0/33
|
|
Renal and urinary disorders
URINARY TRACT INFECTION
|
0.00%
0/26
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
APNEA
|
0.00%
0/26
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
COUGH INCREASED
|
0.00%
0/26
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
3.8%
1/26
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/26
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
7.7%
2/26
|
9.1%
3/33
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLUS
|
0.00%
0/26
|
9.1%
3/33
|
|
Vascular disorders
DEEP THROMBOPHLEBITIS
|
0.00%
0/26
|
3.0%
1/33
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/26
|
3.0%
1/33
|
|
Vascular disorders
MESENTERIC VENOUS OCCLUSION
|
0.00%
0/26
|
3.0%
1/33
|
|
Vascular disorders
THROMBOSIS
|
0.00%
0/26
|
3.0%
1/33
|
Other adverse events
| Measure |
1 No Dexamethasone
n=26 participants at risk
Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
|
2 Dexamethasone
n=33 participants at risk
Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
|
|---|---|---|
|
Blood and lymphatic system disorders
ANEMIA
|
69.2%
18/26
|
72.7%
24/33
|
|
Blood and lymphatic system disorders
ECCHYMOSIS
|
11.5%
3/26
|
0.00%
0/33
|
|
Blood and lymphatic system disorders
HYPOCHROMIC ANEMIA
|
0.00%
0/26
|
9.1%
3/33
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/26
|
30.3%
10/33
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
69.2%
18/26
|
57.6%
19/33
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
7.7%
2/26
|
0.00%
0/33
|
|
Blood and lymphatic system disorders
PETECHIA
|
11.5%
3/26
|
0.00%
0/33
|
|
Blood and lymphatic system disorders
THROMBOCYTHEMIA
|
0.00%
0/26
|
15.2%
5/33
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
69.2%
18/26
|
72.7%
24/33
|
|
Cardiac disorders
TACHYCARDIA
|
11.5%
3/26
|
0.00%
0/33
|
|
Endocrine disorders
CUSHINGS SYNDROME
|
0.00%
0/26
|
9.1%
3/33
|
|
Eye disorders
CONJUNCTIVITIS
|
0.00%
0/26
|
6.1%
2/33
|
|
Gastrointestinal disorders
ANOREXIA
|
19.2%
5/26
|
27.3%
9/33
|
|
Gastrointestinal disorders
CHOLECYSTITIS
|
7.7%
2/26
|
0.00%
0/33
|
|
Gastrointestinal disorders
CONSTIPATION
|
46.2%
12/26
|
54.5%
18/33
|
|
Gastrointestinal disorders
DIARRHEA
|
19.2%
5/26
|
24.2%
8/33
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/26
|
6.1%
2/33
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/26
|
6.1%
2/33
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/26
|
6.1%
2/33
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
0.00%
0/26
|
12.1%
4/33
|
|
Gastrointestinal disorders
NAUSEA
|
61.5%
16/26
|
60.6%
20/33
|
|
Gastrointestinal disorders
ORAL MONILIASIS
|
0.00%
0/26
|
15.2%
5/33
|
|
Gastrointestinal disorders
RECTAL DISORDER
|
0.00%
0/26
|
6.1%
2/33
|
|
Gastrointestinal disorders
STOMATITIS
|
11.5%
3/26
|
27.3%
9/33
|
|
Gastrointestinal disorders
ULCERATIVE STOMATITIS
|
0.00%
0/26
|
6.1%
2/33
|
|
Gastrointestinal disorders
VOMITING
|
46.2%
12/26
|
21.2%
7/33
|
|
General disorders
ABDOMINAL PAIN
|
0.00%
0/26
|
9.1%
3/33
|
|
General disorders
ACCIDENTAL INJURY
|
7.7%
2/26
|
0.00%
0/33
|
|
General disorders
ASTHENIA
|
65.4%
17/26
|
69.7%
23/33
|
|
General disorders
BACK PAIN
|
7.7%
2/26
|
9.1%
3/33
|
|
General disorders
CHEST PAIN
|
11.5%
3/26
|
18.2%
6/33
|
|
General disorders
FACE EDEMA
|
0.00%
0/26
|
6.1%
2/33
|
|
General disorders
FEVER
|
26.9%
7/26
|
15.2%
5/33
|
|
General disorders
HEADACHE
|
7.7%
2/26
|
9.1%
3/33
|
|
General disorders
INJECTION SITE PAIN
|
11.5%
3/26
|
0.00%
0/33
|
|
General disorders
INJECTION SITE REACTION
|
7.7%
2/26
|
0.00%
0/33
|
|
General disorders
LAB TEST ABNORMAL
|
15.4%
4/26
|
21.2%
7/33
|
|
General disorders
MUCOUS MEMBRANE DISORDER
|
7.7%
2/26
|
6.1%
2/33
|
|
General disorders
PAIN
|
42.3%
11/26
|
21.2%
7/33
|
|
Infections and infestations
INFECTION FUNGAL
|
7.7%
2/26
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/26
|
6.1%
2/33
|
|
Metabolism and nutrition disorders
BUN INCREASED
|
0.00%
0/26
|
9.1%
3/33
|
|
Metabolism and nutrition disorders
CREATININE INCREASED
|
0.00%
0/26
|
9.1%
3/33
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
23.1%
6/26
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
EDEMA
|
7.7%
2/26
|
18.2%
6/33
|
|
Metabolism and nutrition disorders
GOUT
|
7.7%
2/26
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
0.00%
0/26
|
9.1%
3/33
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
15.4%
4/26
|
42.4%
14/33
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
0.00%
0/26
|
9.1%
3/33
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
23.1%
6/26
|
39.4%
13/33
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
11.5%
3/26
|
18.2%
6/33
|
|
Metabolism and nutrition disorders
HYPOPROTEINEMIA
|
11.5%
3/26
|
45.5%
15/33
|
|
Metabolism and nutrition disorders
PERIPHERAL EDEMA
|
15.4%
4/26
|
30.3%
10/33
|
|
Metabolism and nutrition disorders
RESPIRATORY ALKALOSIS
|
0.00%
0/26
|
6.1%
2/33
|
|
Metabolism and nutrition disorders
SGOT INCREASED
|
7.7%
2/26
|
21.2%
7/33
|
|
Metabolism and nutrition disorders
SGPT INCREASED
|
7.7%
2/26
|
24.2%
8/33
|
|
Metabolism and nutrition disorders
WEIGHT LOSS
|
7.7%
2/26
|
9.1%
3/33
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/26
|
6.1%
2/33
|
|
Musculoskeletal and connective tissue disorders
MYASTHENIA
|
0.00%
0/26
|
15.2%
5/33
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
7.7%
2/26
|
0.00%
0/33
|
|
Nervous system disorders
ANXIETY
|
7.7%
2/26
|
9.1%
3/33
|
|
Nervous system disorders
CONFUSION
|
0.00%
0/26
|
6.1%
2/33
|
|
Nervous system disorders
DEPRESSION
|
7.7%
2/26
|
6.1%
2/33
|
|
Nervous system disorders
DIZZINESS
|
7.7%
2/26
|
12.1%
4/33
|
|
Nervous system disorders
HYPERTENSION
|
11.5%
3/26
|
6.1%
2/33
|
|
Nervous system disorders
INSOMNIA
|
38.5%
10/26
|
45.5%
15/33
|
|
Nervous system disorders
NEUROPATHY
|
15.4%
4/26
|
12.1%
4/33
|
|
Nervous system disorders
PARESTHESIA
|
0.00%
0/26
|
6.1%
2/33
|
|
Nervous system disorders
URINARY RETENTION
|
0.00%
0/26
|
6.1%
2/33
|
|
Nervous system disorders
VASODILATATION
|
15.4%
4/26
|
21.2%
7/33
|
|
Renal and urinary disorders
KIDNEY FUNCTION ABNORMAL
|
0.00%
0/26
|
6.1%
2/33
|
|
Renal and urinary disorders
URINARY TRACT INFECTION
|
7.7%
2/26
|
6.1%
2/33
|
|
Respiratory, thoracic and mediastinal disorders
COUGH INCREASED
|
38.5%
10/26
|
30.3%
10/33
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
50.0%
13/26
|
39.4%
13/33
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
11.5%
3/26
|
6.1%
2/33
|
|
Respiratory, thoracic and mediastinal disorders
HEMOPTYSIS
|
15.4%
4/26
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
HICCUP
|
0.00%
0/26
|
6.1%
2/33
|
|
Respiratory, thoracic and mediastinal disorders
HYPOVENTILATION
|
0.00%
0/26
|
6.1%
2/33
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
19.2%
5/26
|
6.1%
2/33
|
|
Respiratory, thoracic and mediastinal disorders
LUNG EDEMA
|
0.00%
0/26
|
6.1%
2/33
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGITIS
|
0.00%
0/26
|
12.1%
4/33
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
7.7%
2/26
|
12.1%
4/33
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS
|
11.5%
3/26
|
9.1%
3/33
|
|
Respiratory, thoracic and mediastinal disorders
SINUSITIS
|
7.7%
2/26
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/26
|
15.2%
5/33
|
|
Skin and subcutaneous tissue disorders
RASH
|
30.8%
8/26
|
18.2%
6/33
|
|
Skin and subcutaneous tissue disorders
SWEATING
|
0.00%
0/26
|
21.2%
7/33
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/26
|
6.1%
2/33
|
|
Vascular disorders
PALLOR
|
0.00%
0/26
|
6.1%
2/33
|
Additional Information
Suzane Arnold, MD
University of Kentucky Markey Cancer Center
Phone: 859 323 8043
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place