Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Recurrent Lung Non-Small Cell Carcinoma
  • Stage IV Lung Non-Small Cell Cancer AJCC v7

NCT number NCT01281124
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date January 12, 2011
Completion date September 12, 2012

See also
  Status Clinical Trial Phase
Recruiting NCT04151940 - PET/CT Changes During Chemoimmunotherapy and Radiation Therapy in Patients With Stage IV Non-small Cell Lung Cancer N/A
Recruiting NCT01629498 - Image-Guided, Intensity-Modulated Photon or Proton Beam Radiation Therapy in Treating Patients With Stage II-IIIB Non-small Cell Lung Cancer Phase 1/Phase 2
Completed NCT00254384 - Docetaxel, Cisplatin, and Erlotinib Hydrochloride in Treating Patients With Stage I-III Non-small Cell Lung Cancer Following Surgery Phase 1
Terminated NCT01912625 - Trametinib, Combination Chemotherapy, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery Phase 1
Active, not recruiting NCT04250545 - Testing of the Anti Cancer Drugs CB-839 HCl (Telaglenastat) and MLN0128 (Sapanisertib) in Advanced Stage Non-small Cell Lung Cancer Phase 1
Recruiting NCT04919369 - All-Trans Retinoic Acid (ATRA) and Atezolizumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer Phase 1
Active, not recruiting NCT03600701 - Atezolizumab and Cobimetinib in Treating Patients With Metastatic, Recurrent, or Refractory Non-small Cell Lung Cancer Phase 2
Completed NCT01725165 - Surgery and/or Radiation Therapy or Standard Therapy and/or Clinical Observation in Treating Patients With Previously Treated Stage IV Non-small Cell Lung Cancer Phase 2
Active, not recruiting NCT04514484 - Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV Phase 1
Recruiting NCT05234307 - PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer Phase 1
Active, not recruiting NCT04533451 - Testing the Effects of MK-3475 (Pembrolizumab) With or Without the Usual Chemotherapy Treatment for Patients 70 Years of Age and Older With Advanced Non-small Cell Lung Cancer Phase 2
Recruiting NCT03987555 - Paclitaxel Therapeutic Drug Monitoring in Cancer Patients
Recruiting NCT05642572 - Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A Lung-MAP Treatment Trial) Phase 2
Active, not recruiting NCT03971474 - Ramucirumab and Pembrolizumab Versus Standard of Care in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Non-Match Treatment Trial) Phase 2
Active, not recruiting NCT02496663 - Osimertinib and Necitumumab in Treating Patients With EGFR-Mutant Stage IV or Recurrent Non-small Cell Lung Cancer Who Have Progressed on a Previous EGFR Tyrosine Kinase Inhibitor Phase 1
Active, not recruiting NCT04227028 - Brigatinib and Bevacizumab for the Treatment of ALK-Rearranged Locally Advanced, Metastatic, or Recurrent NSCLC Phase 1
Active, not recruiting NCT02503722 - Testing the Combination of MLN0128 (TAK-228) and AZD9291 in Advanced EGFR (Epidermal Growth Factor Receptor) Mutation Positive Non-small Cell Lung Cancer Phase 1
Active, not recruiting NCT04837716 - Ensartinib, Carboplatin, Pemetrexed and Bevacizumab for the Treatment of Stage IIIC or IV or Recurrent ALK-Positive Non-small Cell Lung Cancer Phase 1
Active, not recruiting NCT03066206 - Poziotinib in EGFR Exon 20 Mutant Advanced NSCLC Phase 2
Active, not recruiting NCT05096663 - Testing the Use of Combination Immunotherapy Treatment (N-803 [ALT-803] Plus Pembrolizumab) Against the Usual Treatment for Advanced Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial) Phase 2/Phase 3