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Trial record 7 of 7 for:    "Pleural Disease" | "Gastrointestinal Agents"

Effects of Carboplatin and Gemcitabine on Stage IIIB Pleural Effusion and Stage IV Lung Cancer

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ClinicalTrials.gov Identifier: NCT00247416
Recruitment Status : Completed
First Posted : November 1, 2005
Results First Posted : March 7, 2014
Last Update Posted : March 7, 2014
Sponsor:
Collaborator:
Kentucky Lung Cancer Research Program
Information provided by (Responsible Party):
Susanne Arnold, University of Kentucky

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Stage IV Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Interventions Drug: Gemcitabine
Drug: Dexamethasone
Drug: Carboplatin
Enrollment 60
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Arm 1, Control, no Dexamethasone Pretreatment Arm 2, Dexamethasone Pretreatment Test Arm
Hide Arm/Group Description 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. 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).
Period Title: Overall Study
Started 26 33
Completed 25 31
Not Completed 1 2
Reason Not Completed
3 patients were found to be ineligible             1             2
Arm/Group Title Arm 1, Control, no Dexamethasone Pretreatment Arm 2, Dexamethasone Pretreatment Test Arm Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 25 31 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 31 participants 56 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
18
  72.0%
27
  87.1%
45
  80.4%
>=65 years
7
  28.0%
4
  12.9%
11
  19.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 31 participants 56 participants
Female
13
  52.0%
14
  45.2%
27
  48.2%
Male
12
  48.0%
17
  54.8%
29
  51.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 31 participants 56 participants
25 31 56
1.Primary Outcome
Title Percentage of Participants With Reduction in Grade 3/4 Neutropenia
Hide Description Reduction grade 3/4 neutropenia
Time Frame continuous throughout treatment, up to 25 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1, Control, no Dexamethasone Pretreatment Arm 2, Dexamethasone Pretreatment Test Arm
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 25 31
Measure Type: Number
Unit of Measure: percentage of participants
40 13
2.Secondary Outcome
Title Effect of Dexamethasone Pre-treatment on 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 Pre-treatment, pre-cycles 3 & 5, and up to 4 weeks after last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 No Dex 2 Dex
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 25 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders out of total
8
(0.1 to 26.0)
26
(11.9 to 44.6)
3.Secondary Outcome
Title Effect of Dexamethasone Pre-treatment on Overall Survival.
Hide Description Overall survival
Time Frame Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, every 3 months, an average of 471 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1, Control, no Dexamethasone Pretreatment Arm 2, Dexamethasone Pretreatment Test Arm
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 25 31
Median (95% Confidence Interval)
Unit of Measure: days
291
(228 to 437)
378
(189 to 608)
4.Secondary Outcome
Title Progression-free Survival
Hide Description progression-free survival
Time Frame Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, and every 3 months, an average of 471 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1, Control, no Dexamethasone Pretreatment Arm 2, Dexamethasone Pretreatment Test Arm
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 25 31
Median (95% Confidence Interval)
Unit of Measure: days
101
(60 to 172)
122
(82 to 185)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1 No Dexamethasone 2 Dexamethasone
Hide Arm/Group Description 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. 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).
All-Cause Mortality
1 No Dexamethasone 2 Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
1 No Dexamethasone 2 Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   7/26 (26.92%)   12/33 (36.36%) 
Blood and lymphatic system disorders     
ANEMIA  0/26 (0.00%)  1/33 (3.03%) 
LEUKOPENIA  0/26 (0.00%)  1/33 (3.03%) 
THROMBOCYTOPENIA  1/26 (3.85%)  2/33 (6.06%) 
Cardiac disorders     
HEART ARREST  1/26 (3.85%)  1/33 (3.03%) 
Gastrointestinal disorders     
CONSTIPATION  2/26 (7.69%)  0/33 (0.00%) 
DIARRHEA  0/26 (0.00%)  1/33 (3.03%) 
DUODENAL ULCER  0/26 (0.00%)  1/33 (3.03%) 
NAUSEA  1/26 (3.85%)  1/33 (3.03%) 
RECTAL DISORDER  0/26 (0.00%)  1/33 (3.03%) 
VOMITING  1/26 (3.85%)  0/33 (0.00%) 
General disorders     
MEDICATION ERROR  0/26 (0.00%)  1/33 (3.03%) 
SEPSIS  0/26 (0.00%)  3/33 (9.09%) 
Metabolism and nutrition disorders     
HYPERGLYCEMIA  0/26 (0.00%)  1/33 (3.03%) 
Musculoskeletal and connective tissue disorders     
PATHOLOGICAL FRACTURE  1/26 (3.85%)  0/33 (0.00%) 
Nervous system disorders     
CEREBROVASCULAR ACCIDENT  0/26 (0.00%)  1/33 (3.03%) 
DIZZINESS  1/26 (3.85%)  0/33 (0.00%) 
Renal and urinary disorders     
URINARY TRACT INFECTION  0/26 (0.00%)  1/33 (3.03%) 
Respiratory, thoracic and mediastinal disorders     
APNEA  0/26 (0.00%)  1/33 (3.03%) 
COUGH INCREASED  0/26 (0.00%)  1/33 (3.03%) 
DYSPNEA  1/26 (3.85%)  1/33 (3.03%) 
HYPOXIA  0/26 (0.00%)  1/33 (3.03%) 
PNEUMONIA  2/26 (7.69%)  3/33 (9.09%) 
PULMONARY EMBOLUS  0/26 (0.00%)  3/33 (9.09%) 
Vascular disorders     
DEEP THROMBOPHLEBITIS  0/26 (0.00%)  1/33 (3.03%) 
HYPOTENSION  0/26 (0.00%)  1/33 (3.03%) 
MESENTERIC VENOUS OCCLUSION  0/26 (0.00%)  1/33 (3.03%) 
THROMBOSIS  0/26 (0.00%)  1/33 (3.03%) 
1
Term from vocabulary, COSTART
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1 No Dexamethasone 2 Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   26/26 (100.00%)   33/33 (100.00%) 
Blood and lymphatic system disorders     
ANEMIA  18/26 (69.23%)  24/33 (72.73%) 
ECCHYMOSIS  3/26 (11.54%)  0/33 (0.00%) 
HYPOCHROMIC ANEMIA  0/26 (0.00%)  3/33 (9.09%) 
LEUKOCYTOSIS  0/26 (0.00%)  10/33 (30.30%) 
LEUKOPENIA  18/26 (69.23%)  19/33 (57.58%) 
PANCYTOPENIA  2/26 (7.69%)  0/33 (0.00%) 
PETECHIA  3/26 (11.54%)  0/33 (0.00%) 
THROMBOCYTHEMIA  0/26 (0.00%)  5/33 (15.15%) 
THROMBOCYTOPENIA  18/26 (69.23%)  24/33 (72.73%) 
Cardiac disorders     
TACHYCARDIA  3/26 (11.54%)  0/33 (0.00%) 
Endocrine disorders     
CUSHINGS SYNDROME  0/26 (0.00%)  3/33 (9.09%) 
Eye disorders     
CONJUNCTIVITIS  0/26 (0.00%)  2/33 (6.06%) 
Gastrointestinal disorders     
ANOREXIA  5/26 (19.23%)  9/33 (27.27%) 
CHOLECYSTITIS  2/26 (7.69%)  0/33 (0.00%) 
CONSTIPATION  12/26 (46.15%)  18/33 (54.55%) 
DIARRHEA  5/26 (19.23%)  8/33 (24.24%) 
DYSPEPSIA  0/26 (0.00%)  2/33 (6.06%) 
DYSPHAGIA  0/26 (0.00%)  2/33 (6.06%) 
FLATULENCE  0/26 (0.00%)  2/33 (6.06%) 
MOUTH ULCERATION  0/26 (0.00%)  4/33 (12.12%) 
NAUSEA  16/26 (61.54%)  20/33 (60.61%) 
ORAL MONILIASIS  0/26 (0.00%)  5/33 (15.15%) 
RECTAL DISORDER  0/26 (0.00%)  2/33 (6.06%) 
STOMATITIS  3/26 (11.54%)  9/33 (27.27%) 
ULCERATIVE STOMATITIS  0/26 (0.00%)  2/33 (6.06%) 
VOMITING  12/26 (46.15%)  7/33 (21.21%) 
General disorders     
ABDOMINAL PAIN  0/26 (0.00%)  3/33 (9.09%) 
ACCIDENTAL INJURY  2/26 (7.69%)  0/33 (0.00%) 
ASTHENIA  17/26 (65.38%)  23/33 (69.70%) 
BACK PAIN  2/26 (7.69%)  3/33 (9.09%) 
CHEST PAIN  3/26 (11.54%)  6/33 (18.18%) 
FACE EDEMA  0/26 (0.00%)  2/33 (6.06%) 
FEVER  7/26 (26.92%)  5/33 (15.15%) 
HEADACHE  2/26 (7.69%)  3/33 (9.09%) 
INJECTION SITE PAIN  3/26 (11.54%)  0/33 (0.00%) 
INJECTION SITE REACTION  2/26 (7.69%)  0/33 (0.00%) 
LAB TEST ABNORMAL  4/26 (15.38%)  7/33 (21.21%) 
MUCOUS MEMBRANE DISORDER  2/26 (7.69%)  2/33 (6.06%) 
PAIN  11/26 (42.31%)  7/33 (21.21%) 
Infections and infestations     
INFECTION FUNGAL  2/26 (7.69%)  0/33 (0.00%) 
Metabolism and nutrition disorders     
ALKALINE PHOSPHATASE INCREASED  0/26 (0.00%)  2/33 (6.06%) 
BUN INCREASED  0/26 (0.00%)  3/33 (9.09%) 
CREATININE INCREASED  0/26 (0.00%)  3/33 (9.09%) 
DEHYDRATION  6/26 (23.08%)  0/33 (0.00%) 
EDEMA  2/26 (7.69%)  6/33 (18.18%) 
GOUT  2/26 (7.69%)  0/33 (0.00%) 
HYPERCALCEMIA  0/26 (0.00%)  3/33 (9.09%) 
HYPERGLYCEMIA  4/26 (15.38%)  14/33 (42.42%) 
HYPOCALCEMIA  0/26 (0.00%)  3/33 (9.09%) 
HYPOKALEMIA  6/26 (23.08%)  13/33 (39.39%) 
HYPONATREMIA  3/26 (11.54%)  6/33 (18.18%) 
HYPOPROTEINEMIA  3/26 (11.54%)  15/33 (45.45%) 
PERIPHERAL EDEMA  4/26 (15.38%)  10/33 (30.30%) 
RESPIRATORY ALKALOSIS  0/26 (0.00%)  2/33 (6.06%) 
SGOT INCREASED  2/26 (7.69%)  7/33 (21.21%) 
SGPT INCREASED  2/26 (7.69%)  8/33 (24.24%) 
WEIGHT LOSS  2/26 (7.69%)  3/33 (9.09%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  0/26 (0.00%)  2/33 (6.06%) 
MYASTHENIA  0/26 (0.00%)  5/33 (15.15%) 
PATHOLOGICAL FRACTURE  2/26 (7.69%)  0/33 (0.00%) 
Nervous system disorders     
ANXIETY  2/26 (7.69%)  3/33 (9.09%) 
CONFUSION  0/26 (0.00%)  2/33 (6.06%) 
DEPRESSION  2/26 (7.69%)  2/33 (6.06%) 
DIZZINESS  2/26 (7.69%)  4/33 (12.12%) 
HYPERTENSION  3/26 (11.54%)  2/33 (6.06%) 
INSOMNIA  10/26 (38.46%)  15/33 (45.45%) 
NEUROPATHY  4/26 (15.38%)  4/33 (12.12%) 
PARESTHESIA  0/26 (0.00%)  2/33 (6.06%) 
URINARY RETENTION  0/26 (0.00%)  2/33 (6.06%) 
VASODILATATION  4/26 (15.38%)  7/33 (21.21%) 
Renal and urinary disorders     
KIDNEY FUNCTION ABNORMAL  0/26 (0.00%)  2/33 (6.06%) 
URINARY TRACT INFECTION  2/26 (7.69%)  2/33 (6.06%) 
Respiratory, thoracic and mediastinal disorders     
COUGH INCREASED  10/26 (38.46%)  10/33 (30.30%) 
DYSPNEA  13/26 (50.00%)  13/33 (39.39%) 
EPISTAXIS  3/26 (11.54%)  2/33 (6.06%) 
HEMOPTYSIS  4/26 (15.38%)  0/33 (0.00%) 
HICCUP  0/26 (0.00%)  2/33 (6.06%) 
HYPOVENTILATION  0/26 (0.00%)  2/33 (6.06%) 
LUNG DISORDER  5/26 (19.23%)  2/33 (6.06%) 
LUNG EDEMA  0/26 (0.00%)  2/33 (6.06%) 
PHARYNGITIS  0/26 (0.00%)  4/33 (12.12%) 
PNEUMONIA  2/26 (7.69%)  4/33 (12.12%) 
RHINITIS  3/26 (11.54%)  3/33 (9.09%) 
SINUSITIS  2/26 (7.69%)  0/33 (0.00%) 
Skin and subcutaneous tissue disorders     
ALOPECIA  0/26 (0.00%)  5/33 (15.15%) 
RASH  8/26 (30.77%)  6/33 (18.18%) 
SWEATING  0/26 (0.00%)  7/33 (21.21%) 
Vascular disorders     
HYPOTENSION  0/26 (0.00%)  2/33 (6.06%) 
PALLOR  0/26 (0.00%)  2/33 (6.06%) 
1
Term from vocabulary, COSTART
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Suzane Arnold, MD
Organization: University of Kentucky Markey Cancer Center
Phone: 859 323 8043
EMail: smarno0@uky.edu
Layout table for additonal information
Responsible Party: Susanne Arnold, University of Kentucky
ClinicalTrials.gov Identifier: NCT00247416     History of Changes
Other Study ID Numbers: CTN-0501
First Submitted: October 28, 2005
First Posted: November 1, 2005
Results First Submitted: August 2, 2013
Results First Posted: March 7, 2014
Last Update Posted: March 7, 2014