Bexarotene, Tretinoin, and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00514293|
Recruitment Status : Unknown
Verified August 2008 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : August 9, 2007
Last Update Posted : January 10, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: bexarotene Drug: capecitabine Drug: carboplatin Drug: cisplatin Drug: docetaxel Drug: tretinoin||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Bexarotene (Targretin) Capsules With Tretinoin and Chemotherapy in Patients With Advanced Non-small-cell Lung Cancer|
|Study Start Date :||January 2007|
|Estimated Primary Completion Date :||December 2011|
- Response rate as measured by RECIST criteria
- Time to progression
- Patient-reported symptoms and side effects
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514293
|United States, California|
|R. Nandan M.D. Incorporated||Recruiting|
|Lakewood, California, United States, 90712|
|Contact: Raghu Nandan, MD 562-272-7630 firstname.lastname@example.org|
|Study Chair:||Raghu Nandan, MD||Raghu Nandan, M.D., Inc|