Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
Conditions
Keywords
Untreated, Lung, Cancer, non-small cell, gemcitabine, gemzar, carboplatin, dexamethasone
Brief summary
The purpose of this study is to find better treatment for lung cancer and to find out what effects the combined treatment of carboplatin and gemcitabine when given with or without dexamethasone have on cancer. This study will determine if dexamethasone, when given before standard chemotherapy will increase the cancer fighting effects and reduce the side effects of chemotherapy.
Detailed description
Subjects enrolled in the study will be placed in one of two treatment arms. All subjects have a 50-50 chance of being placed into either treatment arm. Treatment Arm 1 will receive chemotherapy alone, Treatment Arm 2 will receive chemotherapy with dexamethasone given pre-treatment.
Interventions
DRUGGemcitabine
Gemcitabine 1000 mg/m\^2 intravenously over 30 minutes on days 5 and 12.
DRUGDexamethasone
16 mg bid for 4 days prior to each chemotherapy start.
DRUGCarboplatin
AUC 6.0 intravenously over 30 minutes on day 5.
Sponsors
Kentucky Lung Cancer Research Program
Susanne Arnold
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Untreated, stage IIIB with pleural effusion * Untreated, Stage IV, non-small cell lung cancer * Recurrent after surgery if no previous radiation therapy or chemotherapy were administered as part of their primary treatment, except for palliative radiotherapy * 18 years of age or older * ECOG PS 0, 1 or 2 * At Least one target lesion according to the RECIST Criteria * Adequate organ and marrow function
Exclusion criteria
* Previous cancer history unless they have had curative treatment completed at least 5 years prior to entry. * No previous radiotherapy, chemotherapy or immunotherapy for NSCLC, except for radiation therapy to the brain to control metastasis, bone to control pain, or lung to relieve bronchial obstruction. * No radiation therapy for any previous cancer to more than 25% of bone marrow. * Uncontrolled, intercurrent illness * Non-study corticosteroids * Pregnant women * Peripheral neuropathy greater than grade 1 * Uncontrolled seizures, central nervous system disorders * Major surgery within 4 weeks of the start of study treatment * Lack of complete recovery from major surgery. * Glaucoma * Lack of physical integrity of upper gastrointestinal tract, inability to swallow tablets * Severe acquired or hereditary immunodeficiency * Patients with brain metastases must receive definitive treatment (radiation, surgery or both) and be clinically and radiologically stable for 4 weeks & off corticosteroids for at least 2 weeks prior to randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Reduction in Grade 3/4 Neutropenia | continuous throughout treatment, up to 25 weeks | Reduction grade 3/4 neutropenia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Dexamethasone Pre-treatment on Overall Survival. | Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, every 3 months, an average of 471 days | Overall survival |
| Progression-free Survival | Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, and every 3 months, an average of 471 days | progression-free survival |
| Effect of Dexamethasone Pre-treatment on Response Rate. | Pre-treatment, pre-cycles 3 & 5, and up to 4 weeks after last treatment | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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). | 31 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | 3 patients were found to be ineligible | 1 | 2 |
Baseline characteristics
| Characteristic | Arm 1, Control, no Dexamethasone Pretreatment | Arm 2, Dexamethasone Pretreatment Test Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 4 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 27 Participants | 45 Participants |
| Region of Enrollment United States | 25 participants | 31 participants | 56 participants |
| Sex: Female, Male Female | 13 Participants | 14 Participants | 27 Participants |
| Sex: Female, Male Male | 12 Participants | 17 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 26 / 26 | 33 / 33 |
| serious Total, serious adverse events | 7 / 26 | 12 / 33 |
Outcome results
Primary
Percentage of Participants With Reduction in Grade 3/4 Neutropenia
Reduction grade 3/4 neutropenia
Time frame: continuous throughout treatment, up to 25 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 No Dex | Percentage of Participants With Reduction in Grade 3/4 Neutropenia | 40 percentage of participants |
| 2 Dex | Percentage of Participants With Reduction in Grade 3/4 Neutropenia | 13 percentage of participants |
Secondary
Effect of Dexamethasone Pre-treatment on Overall Survival.
Overall survival
Time frame: Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, every 3 months, an average of 471 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 1 No Dex | Effect of Dexamethasone Pre-treatment on Overall Survival. | 291 days |
| 2 Dex | Effect of Dexamethasone Pre-treatment on Overall Survival. | 378 days |
Secondary
Effect of Dexamethasone Pre-treatment on Response Rate.
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 No Dex | Effect of Dexamethasone Pre-treatment on Response Rate. | 8 percentage of responders out of total |
| 2 Dex | Effect of Dexamethasone Pre-treatment on Response Rate. | 26 percentage of responders out of total |
Secondary
Progression-free Survival
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 1 No Dex | Progression-free Survival | 101 days |
| 2 Dex | Progression-free Survival | 122 days |