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Sponsored by: |
Raghu Nandan, M.D., Inc |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00514293 |
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 | Intervention | Phase |
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Lung Cancer |
Drug: bexarotene Drug: capecitabine Drug: carboplatin Drug: cisplatin Drug: docetaxel Drug: tretinoin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Bexarotene (Targretin) Capsules With Tretinoin and Chemotherapy in Patients With Advanced Non-Small-Cell Lung Cancer |
Estimated Enrollment: | 39 |
Study Start Date: | January 2007 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
PATIENT CHARACTERISTICS:
Inclusion criteria:
Absence of hepatic dysfunction that is characterized by the following:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
Inclusion criteria
Exclusion criteria
United States, California | |
R. Nandan M.D. Incorporated | Recruiting |
Lakewood, California, United States, 90712 | |
Contact: Raghu Nandan, MD 562-272-7630 traghu9@hotmail.com |
Study Chair: | Raghu Nandan, MD | Raghu Nandan, M.D., Inc |
Responsible Party: | R. Nandan M.D. Incorporated ( Raghu Nandan ) |
Study ID Numbers: | CDR0000561066, EISAI-2007-01-22 |
Study First Received: | August 8, 2007 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00514293 History of Changes |
Health Authority: | Unspecified |
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Antimetabolites Anticarcinogenic Agents Thoracic Neoplasms Capecitabine Carboplatin Recurrence Carcinoma Keratolytic Agents Docetaxel |
Cisplatin Respiratory Tract Diseases Lung Neoplasms Bexarotene Lung Diseases Non-small Cell Lung Cancer Tretinoin Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Anticarcinogenic Agents Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Keratolytic Agents Neoplasms by Site Respiratory Tract Diseases Bexarotene Lung Neoplasms Therapeutic Uses |
Dermatologic Agents Respiratory Tract Neoplasms Capecitabine Neoplasms by Histologic Type Carboplatin Protective Agents Pharmacologic Actions Carcinoma Neoplasms Lung Diseases Tretinoin Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |