Bexarotene, Tretinoin, and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

NCT00514293 | Unknown Phase 2

• 2 other identifiers: CDR0000561066EISAI-2007-01-22
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

• Response rate as measured by RECIST criteria

• Time to progression

Secondary Outcomes (2)

• Survival

• Patient-reported symptoms and side effects

Interventions

bexarotene DRUG

capecitabine DRUG

carboplatin DRUG

cisplatin DRUG

docetaxel DRUG

tretinoin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG performance status 0-2
• Absence of hepatic dysfunction that is characterized by the following:
• AST/ALT \> 3 times upper limit of normal (ULN) (unless due to liver metastases)
• Bilirubin \> 3 times ULN (unless due to liver metastases)
• ANC ≥ 1,500/mm\^3
• Platelets ≥ 100,000/mm\^3
• Negative pregnancy test prior to the initiation of treatment
• Female and male patients of childbearing potential must agree to sexual abstinence for at least 4 weeks prior to study OR practice 2 reliable forms of effective contraception simultaneously (strongly recommended that one of the two forms of contraception be non-hormonal) at least 4 weeks prior to, during the entire study treatment, and for at least 1 month after treatment is discontinued
• Male patients with female sexual partners who are pregnant, possibly pregnant, or who could become pregnant during the study must agree to use condoms during sexual intercourse during the entire study treatment and for at least 1 month after the last dose of bexarotene
• Must be willing and able to give informed consent, comply with study instructions, and commit to all study visits

You may not qualify if:

• Pregnancy, intent to become pregnant, or breast-feeding
• Significant concurrent or intercurrent illness
• Risk factor for pancreatitis (e.g., uncontrolled hyperlipidemia, excessive alcohol consumption, uncontrolled diabetes mellitus, biliary tract disease)
• Untreated hypothyroidism
• Active second malignancy with the exception of carcinoma in situ, early-stage prostate cancer, and squamous or basal cell carcinoma of skin
• Unwillingness or inability to minimize exposure to sunlight and artificial ultraviolet light while receiving bexarotene
• Known contraindication (according to product labeling) to Lipitor\^® (or another selected lipid lowering agent) or levothyroxine
• Known hypersensitivity to bexarotene or other component of bexarotene
• PRIOR CONCURRENT THERAPY:
• Tyrosine kinase inhibitor therapy such as erlotinib hydrochloride is allowed for up to 3 months prior to initiation of this regimen provided the disease is unresponsive to such treatment
• Concurrent radiation therapy administered for symptom relief
• Also see Disease Characteristics
• Prior therapy, except radiation to the brain for palliation, as long as a measurable lesion is still present
• Prior use of bexarotene
• Prior systemic anticancer therapy (e.g., immunotherapy, chemotherapy, or biologic modifier therapy)

Sponsors & Collaborators

• Raghu Nandan, M.D., Inc: lead

Study Sites (1)

R. Nandan M.D. Incorporated

Lakewood, California, 90712, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Bexarotene; Capecitabine; Carboplatin; Cisplatin; Docetaxel; Tretinoin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Cyclohexenes; Cyclohexanes; Pigments, Biological; Biological Factors

Study Officials

• Raghu Nandan, MD

  Raghu Nandan, M.D., Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 8, 2007
• First Posted: August 9, 2007
• Study Start: January 1, 2007
• Primary Completion: December 1, 2011
• Last Updated: January 10, 2014

Record last verified: 2008-08

Locations

US (1)