Residual Hypermethylation in Early Stage Non-Small Cell Lung Cancer (NSCLC) As Part of Adjuvant Therapy and Preventive Strategy

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT01209520
Status
Completed

Conditions

  • Hypermethylation
  • Lung Cancer
  • Non Small Cell Lung Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin — DRUG
    Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
  • Carboplatin — DRUG
    Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
  • Paclitaxel — DRUG
    Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
  • Vidaza — DRUG
    Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles
  • Tumor Specimen for Methylation Analysis — PROCEDURE
    Obtained from tissue of resected NSCLC tumor.
  • Blood Sample for Methylation Analysis — PROCEDURE
    Pre-Surgery, Post-Surgery, Post-Vidaza Therapy and during follow-up.
  • Vinorelbine — DRUG
    Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
  • Docetaxel — DRUG
    Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
  • Pemetrexed — DRUG
    Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.

Study Details

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.

Key Dates

Start date
Jul 31, 2009
Status verified
Feb 2015
Primary completion
Dec 31, 2013

Study Design

Enrollment
6 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adjuvant Chemotherapy + Vidaza

Primary Outcome Measure

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. [ Time Frame: Up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Miami Sylvester Comprehensive Cancer CenterMiamiFlorida33136-

Find similar trials in Miami, FL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Miami Sylvester Comprehensive Cancer Center· Miami, FL

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