Azacitidine and Entinostat Before Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01935947
Phase
PHASE2
Status
Terminated

Conditions

  • Recurrent Non-Small Cell Lung Carcinoma
  • Stage IIIA Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Azacitidine — DRUG
    Given SC
  • Azacitidine — DRUG
    Given PO
  • Docetaxel — DRUG
    Given IV
  • Entinostat — DRUG
    Given PO
  • Gemcitabine Hydrochloride — DRUG
    Given IV
  • Irinotecan Hydrochloride — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pemetrexed Disodium — DRUG
    Given IV

Study Details

This randomized phase II trial studies how well azacitidine and entinostat before chemotherapy works in treating patients with non-small cell lung cancer that has spread to other places in the body. Drugs used in chemotherapy, such as azacitidine, irinotecan hydrochloride, gemcitabine hydrochloride, docetaxel, and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving azacitidine and entinostat before chemotherapy may work better in treating patients with non-small cell lung cancer.

Key Dates

Start date
May 31, 2013
Status verified
Jun 2018
Primary completion
Apr 30, 2017
Completion
Apr 30, 2017

Study Design

Enrollment
17 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (azacitidine, entinostat, chemotherapy)
    Patients receive azacitidine SC on days 1-6 and 8-10 and entinostat PO on days 3 and 10. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or progressive disease receive chemotherapy of the treating oncologist's choice comprising irinotecan hydrochloride IV on day 1, docetaxel IV on day 1, pemetrexed disodium IV on day 1, or gemcitabine hydrochloride IV on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II (azacitidine, entinostat, chemotherapy)
    Patients receive azacitidine PO on days 1-21 and entinostat PO on days 3 and 10. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or progressive disease receive chemotherapy of the treating oncologist's choice as in Arm A.
  • Active Comparator: Arm III (chemotherapy)
    Patients receive chemotherapy of the treating oncologist's choice as in Arm A.

Primary Outcome Measure

Percentage of Patients Progression-free at 6 Months From the Time of Randomization [ Time Frame: At 6 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
USC Norris Oncology/Hematology-Newport BeachNewport BeachCalifornia92663-
Johns Hopkins Bayview Medical CenterBaltimoreMaryland21224-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
Medical University of South CarolinaCharlestonSouth Carolina29425-

Find similar trials in Los Angeles, CA

By research site
USC / Norris Comprehensive Cancer Center· Los Angeles, CAUSC Norris Oncology/Hematology-Newport Beach· Newport Beach, CAJohns Hopkins Bayview Medical Center· Baltimore, MDJohns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MDMedical University of South Carolina· Charleston, SC

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