Non-small Cell Lung Cancer
Conditions
Keywords
NSCLC, Targretin, Retinoid, Bexarotene
Brief summary
This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.
Detailed description
This study evaluates the use of Targretin capsules (bexarotene) in combination with Carboplatin and Paclitaxel for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer. Every patient receives a platinum-containing chemotherapy every three weeks for at least four chemotherapy cycles (approximately four months). Half of the patients are randomly assigned to receive Targretin capsules once daily in addition to the chemotherapy. The other half is randomized to receive a standard platinum-containing chemotherapy without Targretin capsules.
Interventions
DRUGbexarotene with carboplatin and paclitaxel
bexarotene capsules (400 mg/m\^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks.
Sponsors
Eisai Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patients must have: * Pathologic (histologic or cytologic) confirmation of NSCLC * Stage IIIB with malignant pleural effusion or Stage IV disease * At least one measurable or evaluable NSCLC lesion that has not been previously irradiated unless radiation therapy was more than three weeks prior to entry in the study and the lesion has been shown to have progressed subsequent to the radiation therapy * ECOG performance status 0 or 1 * Adequate organ system function * Fasting serum triglycerides that are within the age-adjusted normal range (or normalized with appropriate intervention such as antilipid therapy prior to the initiation of Targretin capsule therapy). Patients must be able to complete at least four cycles of combination chemotherapy (i.e., approximately four months) Patients must not have had: * Brain metastasis * Prior chemotherapy for NSCLC * Prior platinum-based chemotherapy for any indication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | From date of randomization to date of death |
Countries
Austria, Canada, France, Germany, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bexarotene With Carboplatin and Paclitaxel bexarotene capsules (400 mg/m\^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator. | 306 |
| Carboplatin and Paclitaxel carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks. | 306 |
| Total | 612 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative | 31 | 46 |
| Overall Study | Adverse Event | 62 | 61 |
| Overall Study | Complete Response | 0 | 2 |
| Overall Study | Death | 13 | 15 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Non-compliance | 3 | 1 |
| Overall Study | Partial Response | 14 | 19 |
| Overall Study | Progressive Disease | 137 | 93 |
| Overall Study | Stable Disease | 19 | 48 |
| Overall Study | Withdrawal by Subject | 23 | 18 |
Baseline characteristics
| Characteristic | Bexarotene With Carboplatin and Paclitaxel | Carboplatin and Paclitaxel | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 140 Participants | 132 Participants | 272 Participants |
| Age, Categorical Between 18 and 65 years | 166 Participants | 174 Participants | 340 Participants |
| Age Continuous | 62.5 years STANDARD_DEVIATION 9.6 | 61.7 years STANDARD_DEVIATION 10.3 | 62.1 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 9 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 304 Participants | 297 Participants | 601 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 3 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 20 Participants | 43 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) White | 269 Participants | 272 Participants | 541 Participants |
| Sex: Female, Male Female | 103 Participants | 103 Participants | 206 Participants |
| Sex: Female, Male Male | 203 Participants | 203 Participants | 406 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 293 / 293 | 295 / 295 |
| serious Total, serious adverse events | 256 / 293 | 242 / 295 |
Outcome results
Primary
Overall Survival
Time frame: From date of randomization to date of death
Population: Intent-to-Treat (ITT)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bexarotene With Carboplatin and Paclitaxel | Overall Survival | 8.5 Months |
| Carboplatin and Paclitaxel | Overall Survival | 9.2 Months |