Bexarotene, Tretinoin, and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Recruitment status was: Recruiting
RATIONALE: Bexarotene and tretinoin may cause tumor cells to look more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as cisplatin, carboplatin, docetaxel, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bexarotene and tretinoin together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving bexarotene together with tretinoin and combination chemotherapy works in treating patients with stage III or stage IV non-small cell lung cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Bexarotene (Targretin) Capsules With Tretinoin and Chemotherapy in Patients With Advanced Non-small-cell Lung Cancer|
- Response rate as measured by RECIST criteria [ Designated as safety issue: No ]
- Time to progression [ Designated as safety issue: No ]
- Survival [ Designated as safety issue: No ]
- Patient-reported symptoms and side effects [ Designated as safety issue: Yes ]
|Study Start Date:||January 2007|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
- Evaluate the efficacy of bexarotene at a dose of 375 mg daily for 4 days with tretinoin also for the same 3 days with chemotherapy in patients with advanced non-small cell lung cancer.
- Evaluate the safety and tolerability of this drug combination.
OUTLINE: Patients will receive oral bexarotene 375 mg once daily and oral tretinoin 50 mg twice daily on days 1-3. Patients also receive combination chemotherapy comprising cisplatin or carboplatin with docetaxel and capecitabine orally or intravenously on days 1-3. Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients will be followed every 4 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514293
|United States, California|
|R. Nandan M.D. Incorporated|
|Lakewood, California, United States, 90712|
|Study Chair:||Raghu Nandan, MD||Raghu Nandan, M.D., Inc|