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| Sponsor: | Raghu Nandan, M.D., Inc |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00514293 |
Purpose
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 |
|---|---|---|
|
Lung Cancer |
Drug: bexarotene Drug: capecitabine Drug: carboplatin Drug: cisplatin Drug: docetaxel Drug: tretinoin |
Phase II |
| Study Type: | Interventional |
| 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 |
| 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.
Eligibility| 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
Contacts and Locations| 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 |
More Information
| Responsible Party: | Raghu Nandan, R. Nandan M.D. Incorporated |
| ClinicalTrials.gov Identifier: | NCT00514293 History of Changes |
| Other Study ID Numbers: | CDR0000561066, EISAI-2007-01-22 |
| Study First Received: | August 8, 2007 |
| Last Updated: | October 8, 2008 |
| Health Authority: | Unspecified |
|
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Docetaxel Bexarotene Capecitabine Cisplatin |
Tretinoin Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Keratolytic Agents Dermatologic Agents Anticarcinogenic Agents Protective Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |