Phase 3
N=612
Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
Non-small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00050960 ↗Enrolled (actual)
612
Serious AEs
84.7%
Results posted
Aug 2010
Primary outcome: Primary: Overall Survival — 8.5; 9.2 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- bexarotene with carboplatin and paclitaxel (Drug); carboplatin and paclitaxel (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Eisai Inc.
- Primary completion
- Jul 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
8.5; 9.2 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00050960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.