N/A
N=6
Residual Hypermethylation in Early Stage Non-Small Cell Lung Cancer (NSCLC) As Part of Adjuvant Therapy and Preventive Strategy
Lung Cancer · Non Small Cell Lung Carcinoma · Hypermethylation
Bottom Line
View on ClinicalTrials.gov: NCT01209520 ↗Enrolled (actual)
6
Serious AEs
16.7%
Results posted
Feb 2015
Primary outcome: Primary: Percentage of Patients Showing a Presence of Methylated Tumor Suppressor Genes in Their Tumor Tissue and/or Serum Achieving Partial or Complete Response to Protocol Therapy.
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cisplatin (Drug); Carboplatin (Drug); Paclitaxel (Drug); Vidaza (Drug); Tumor Specimen for Methylation Analysis (Procedure); Blood Sample for Methylation Analysis (Procedure); Vinorelbine (Drug); Docetaxel (Drug); Pemetrexed (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Showing a Presence of Methylated Tumor Suppressor Genes in Their Tumor Tissue and/or Serum Achieving Partial or Complete Response to Protocol Therapy. |
— | — |
| PRIMARY Degree of Demethylation in Patient Tumor Tissue and/or Serum Induced by 5-azacitidine on Specific Tumor Specific Genes (TSGs) |
— | — |
Summary
The trial investigates the feasibility and efficacy of targeting Non-Small Cell Lung Cancer (NSCLC) "driven" by epigenetic changes. The investigators study the impact of 5-azacitidine (Vidaza®, Celgene, Summit, NJ, USA) in combination with conventional cytotoxic chemotherapy in a sequential fashion. The study population consists of all NSCLC patients who undergo "curative" lung cancer resection and whose tumors harbor hypermethylation in any of the protocol-specific genes (samples will be banked for additional molecular testing including other 21 loci which have shown to be important in lung carcinogenesis.
Eligibility Criteria
Inclusion Criteria
- Patients must have a pathologic diagnosis of NSCLC.
- Patients must have surgical resection for NSCLC (stage I-IIIA) and tumor specimen (ideally) and/or blood sample available for biological correlative studies.
- Patient's tumor specimen and/or blood sample must show hypermethylation in at least one (1) of the following genes: DAPK, RASSF1A, CDKN2A (p16INK4a), GATA-4, GATA-5, SPARC, MGMT, APC, and hMLH1.
- Patient's age must be 18 years or greater.
- Patients must have adequate organ and marrow function prior to be enrolled into the trial, as defined below:
- Absolute neutrophil count (ANC) > 1500/mm3
- Platelets > 100,000/mm3
- Hemoglobin > 8.0 g/dL (with packed red blood cell transfusion or use of erythropoietin stimulating agents allowed)
- Serum creatinine 12 months.
- Patients must be able to understand and agree to sign an IRB-approved informed consent form, including permission to draw blood sample for correlative studies during active treatment and follow-up.
- Women of child-bearing potential and men must agree to use adequate contraceptive method (hormonal or barrier method of birth control) prior to study entry for the duration of study.
- Women of childbearing potential must have a negative serum pregnancy test prior to start targeted therapy with 5-azacitidine.
- Patients with HIV infection (but not AIDS) are eligible for this trial. Therefore, no HIV testing will be required.
Exclusion Criteria
- Patients who are not candidates for surgical resection.
- Patients who have received radiation therapy.
- No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, breast DCIS adequately treated, or other cancer for which the subject has been disease-free ≥ 5 years.
- Subjects should not have a significant history of cardiac disease (e.g., unstable angina, congestive heart failure, or uncontrolled arrhythmias).
- Subjects must not have an uncontrolled seizure disorder, or active neurological disease.
- Patients who have significant systemic infections including AIDS.
- Pregnant and/or lactating women.
- Known or suspected hypersensitivity to azacitidine or mannitol.
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical illnesses.
Data sourced from ClinicalTrials.gov (NCT01209520). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.