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other trials show no survival benefit of bexarotene with platinum-based chemo
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
| Ligand Pharmaceuticals | INDUSTRY |
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The primary aim is to evaluate the safety (Phase I components) of administering bexarotene (Targretin®, LGD1069) oral capsules in combination with two Taxol® and carboplatin (Paraplatin®) schedules to patients with stage IIIB and IV non-small cell lung cancer. This study will also evaluate the preliminary efficacy (Phase II component) of bexarotene oral capsules in combination with the weekly Taxol® schedule and carboplatin in these patients.
The phase I portion of the study will evaluate the safety of administering bexarotene oral capsules daily at two dose levels (300 mg/m2 and 400 mg/m2) in combination with carboplatin and Taxol®. At least 6 patients will be entered onto each dose level. Doses will not be escalated over the course of treatment of an individual patient. The recommended Phase II dose is defined as the highest dose of bexarotene oral capsules (300 mg/m2 or 400 mg/m2) in combination with carboplatin and Taxol® that induces DLT in fewer than or equal to 33% of patients.
The sequential phase II portion of the study will evaluate the efficacy of bexarotene oral capsules in combination with carboplatin and weekly Taxol® in patients with advanced non-small cell lung cancer. The efficacy will be gauged according to the rate of major response where, by definition, a major response occurs if a patient achieves either complete remission (CR) or partial remission (PR). For these patients a true response rate of 20% or greater is sufficiently large to warrant further investigation. A true response rate of 10% or less indicates that the combination is less active.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bexarotene | Experimental | Bexarotene oral capsules will be administered daily beginning on the initial day of chemotherapy (day 1). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bexarotene (targretin) | Drug | Bexarotene oral capsules will be administered daily beginning on the initial day of chemotherapy (day 1). Level 1: 300 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bexarotene Oral Capsules Safety at Two Dose Levels (300 mg/m2 and 400 mg/m2) in Combination With Carboplatin and Taxol®. | At least 6 patients will be entered onto each dose level. Doses will not be escalated over the course of treatment of an individual patient. For the purpose of this protocol, an initial-dose-limiting toxicity (IDLT) is defined as a clinical observation that is, in the judgment of the Investigator, both attributable to the administration of bexarotene and necessitates a reduction in dose, suspension or discontinuation of study drug because of a NCI CTC Grade 3 or 4 level toxicity (with the exception of elevated lipids). | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James R Rigas, MD | Norris Cotton Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norris Cotton Cancer Center | Lebanon | New Hampshire | 03756 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase IB | Bexarotene 300mg vs 400mg administered with paclitaxel and carboplatin |
| FG001 | Phase II | Bexarotene 400mg in combination with Paraplatin and weekly Taxol. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Bexarotene (targretin) | Drug | Bexarotene oral capsules will be administered daily beginning on the intitial day of chemotherapy (Day 1). Level 2: 400 mg |
|
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase IB | Bexarotene 300mg vs 400mg administered with paclitaxel and carboplatin |
| BG001 | Phase II | Bexarotene 400mg in combination with Paraplatin and weekly Taxol. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bexarotene Oral Capsules Safety at Two Dose Levels (300 mg/m2 and 400 mg/m2) in Combination With Carboplatin and Taxol®. | At least 6 patients will be entered onto each dose level. Doses will not be escalated over the course of treatment of an individual patient. For the purpose of this protocol, an initial-dose-limiting toxicity (IDLT) is defined as a clinical observation that is, in the judgment of the Investigator, both attributable to the administration of bexarotene and necessitates a reduction in dose, suspension or discontinuation of study drug because of a NCI CTC Grade 3 or 4 level toxicity (with the exception of elevated lipids). | Posted | Number | participants experiencing IDLT | 36 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase IB - Bexarotene 300mg, Paclitaxel and Carboplatin | Bexarotene 300mg administered with paclitaxel and carboplatin | 0 | 14 | 1 | 14 | 0 | 14 |
| EG001 | Phase IB - Bexarotene 400mg, Paclitaxel and Carboplatin | Bexarotene 400mg administered with paclitaxel and carboplatin | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | Phase II | Bexarotene 400mg in combination with Paraplatin and weekly Taxol. | 0 | 7 | 2 | 7 | 0 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myelosuppression | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Hypertriglyceridemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Rigas, MD | Dartmouth-Hitchcock Medical Center | 603-650-6344 | Cancer.Research.Nurse@Dartmouth.edu |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077610 | Bexarotene |
| ID | Term |
|---|---|
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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| >=65 years |
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| Male |
|