Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 1:07 AM
NCT ID:
NCT00514293
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
* Stage IIIB disease with a malignant pleural effusion
* Stage IV disease
* Chemotherapy-naive disease
* Brain metastases allowed provided patients have completed radiation treatment with no actively progressing brain metastases
PATIENT CHARACTERISTICS:
Inclusion criteria:
* 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
Exclusion criteria:
* 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:
Inclusion criteria
* 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
Exclusion criteria
* 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)
* Medication known to increase triglyceride levels or associated with pancreatic toxicity
* Systemic vitamin A in doses exceeding 15,000 IU/day within 14 days prior to initiating study therapy
* Concurrent gemfibrozil (Lopid\^®)
* Concurrent anticancer therapy of any kind other than that mandated by the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00514293
Study Brief:
Protocol Section:
NCT00514293