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About
This phase II clinical trial is studying how well azacitidine works in treating patients with previously treated advanced non-small cell lung cancer. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Full description
PRIMARY OBJECTIVES:
I. To determine the ability of 5-azacytidine to cause DNA hypomethylation and re-expression of silenced tumor suppressor genes when stratified for high or low expression of mir29a, b, and c.
SECONDARY OBJECTIVES:
I. To compare the molecular studies (mir29 expression and tumor suppressor gene methylation) between archival tissue, fresh biopsy pre-treatment samples, and post-treatment fresh samples.
II. To determine the overall response rate by CT (RECIST 1.1 criteria) and PET (EORTC PET response criteria), PFS, and OS of patients treated with azacytidine in the second- or third-line setting.
III. To correlate the blood microRNA profiles (and changes in microRNA profiles) with response to azacytidine.
OUTLINE:
Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo tissue and blood sample collection at baseline and periodically during study treatment for correlative studies. After completion of study treatment, patients are followed up for 12 weeks.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria:
Advanced (stage 4 or recurrent) NSCLC, not eligible for any curative intent treatment
Measurable disease (as defined by RECIST criteria)
Patients may have up to two (and at least one) prior cytotoxic regimens in the metastatic setting
No patients with uncontrolled brain metastases or leptomeningeal disease
ECOG performance status 0-2
Absolute neutrophil count ≥ 1.5 x 10^9/L
Platelets ≥ 100,000 x 10^9/L
Hemoglobin ≥ 9.0 gm/100 mL
Total bilirubin ≤ 1.5 mg/dL
AST and ALT ≤ 2.5 x ULN
Creatinine ≤ 1.5 mg/dL OR calculated creatinine clearance > 50 mL/min
No patients who are pregnant
Women of childbearing potential must have a negative pregnancy test
The patient must be willing to use adequate contraception for the duration of study treatment and up to four weeks following the last dose of drug
Archival diagnostic material sufficient for microRNA evaluation/assessment is preferred, though optional
Willing to undergo biopsy pre-treatment and following first cycle
No known HIV or hepatitis B or C (though testing for this is not required)
No uncontrolled intercurrent illness including, but not limited to:
No patients who have significant psychiatric illness that, in the opinion of the principal investigator, would prevent adequate informed consent or render therapy unsafe
Patients may not have had a prior invasive malignancy except for adequately treated non-melanoma cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 2 years
No other concurrent palliative radiotherapy
Recovered from prior surgery, radiation, or chemotherapy to ≤ grade 2 toxicity
Palliative radiation or surgical procedures (for example, endobronchial therapy) is allowed, but must have been completed > 2 weeks prior to starting treatment
No other investigational or commercial agents or therapies may be administered with the intent to treat the patient's malignancy
No other concurrent investigational therapy
Primary purpose
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1 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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