Recurrent Lung Non-Small Cell Carcinoma Clinical Trial
Official title:
Pilot Phase II Study of 5-Azacytidine in Previously Treated Patients With Advanced NSCLC
Verified date | September 2019 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1 |
Est. completion date | September 12, 2012 |
Est. primary completion date | April 15, 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Advanced (stage 4 or recurrent) NSCLC, not eligible for any curative intent treatment - Tumor must be histologically or cytologically confirmed - Measurable disease (as defined by RECIST criteria) - Patients may have up to two (and at least one) prior cytotoxic regimens in the metastatic setting - Prior adjuvant chemotherapy following resection or definitive chemo-radiation for patients with locally advanced disease is not included in this - Allowable systemic therapy in the metastatic setting includes 2 cytotoxic regimens and erlotinib and/or other non-cytotoxic drugs (i.e., erlotinib, sorafenib, and other tyrosine kinase inhibitors do not count as a "cytotoxic regimen") - Prior adjuvant therapy or definitive chemo-radiation is allowed if completed > six months before the onset of "first-line" therapy in the metastatic setting - in this setting, adjuvant or definitive chemo-radiation will not "count" as one of the two cytotoxic regimens; if however, the patient relapses within six months from completion of adjuvant or definitive chemoradiation, then this therapy will be considered the first-line cytotoxic therapy - In the unusual circumstance where patients receive "adjuvant" therapy following resection of oligo-metastatic disease (for example brain metastasis and lung primary resections) and the treating physician decides to administer chemotherapy following all surgery, this will be considered "adjuvant" therapy and the same rules as noted above will apply for initiation of first-line systemic therapy - No patients with uncontrolled brain metastases or leptomeningeal disease - Patients with controlled brain metastases are allowed - 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 - The presence of archival material will not preclude the need for pre and post treatment biopsies - Willing to undergo biopsy pre-treatment and following first cycle - Biopsy may be from any accessible site (primary or metastatic) - No known HIV or hepatitis B or C (though testing for this is not required) - No uncontrolled intercurrent illness including, but not limited to: - Symptomatic CHF - Unstable angina pectoris - Serious cardiac arrhythmia - Serious infection - Psychiatric illness or social situations that would limit compliance with study requirements - 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 - For example, a stage 1 (T1c) prostate cancer 2 years prior to a diagnosis of NSCLC would not be exclusionary, however, a metastatic prostate cancer currently receiving hormonal or chemotherapy would be excluded - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | DNA Hypomethylation and Re-expression of Silenced Tumor Suppressor Genes When Stratified for Low or High Expression of mir29 | The change in mean methylation of the genes between the patients with a low mir29 and a high mir29 expression will be evaluated by a two-sample t-test. Secondary analyses include a multivariate regression where all 5 changes in methylation will be regressed on mir29 expression (low vs. high) and adjusted for patient demographic and clinical attributes at baseline. | Up to 12 weeks after completion of study treatment | |
Secondary | Overall Survival | Analyzed using a Kaplan-Meier methods. | From the day of initial treatment until death (from any cause), assessed up to 12 weeks after completion of study treatment | |
Secondary | Progression-free Survival | Analyzed using a Kaplan-Meier methods. | From the day of initial treatment until documented disease progression (per PET) or death, assessed up to 12 weeks after completion of study treatment |
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 |