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Azacitidine and Entinostat in Treating Patients With Stage I Non-Small Cell Lung Cancer That Has Been Removed By Surgery

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ClinicalTrials.gov Identifier: NCT01207726
Recruitment Status : Terminated (Slow Accrual due to patients not wanting daily clinic administration of 5AZA and/or 6 months of treatment after surgery.)
First Posted : September 23, 2010
Results First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Stage IA Non-Small Cell Lung Carcinoma
Stage IB Non-Small Cell Lung Carcinoma
Interventions Drug: Azacitidine
Drug: Entinostat
Other: Laboratory Biomarker Analysis
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Azacitidine SC and Entinostat Oral Chemotherapy Alone
Hide Arm/Group Description Patients receive azacitidine SC on days 1-5 and 8-10 and entinostat PO QD on days 3 and 10. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Standard of care chemotherapy
Period Title: Overall Study
Started 7 6
Completed 7 6
Not Completed 0 0
Arm/Group Title Azacitidine SC and Entinostat PO Cytotoxic Therapy Total
Hide Arm/Group Description Patients receive azacitidine SC on days 1-5 and 8-10 and entinostat PO QD on days 3 and 10. Followed by Cytotoxic Therapy investigator Choice Standard of care Total of all reporting groups
Overall Number of Baseline Participants 7 6 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  57.1%
1
  16.7%
5
  38.5%
>=65 years
3
  42.9%
5
  83.3%
8
  61.5%
[1]
Measure Analysis Population Description: Study stopped due to early stopping rule
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 7 participants 6 participants 13 participants
66
(58 to 70)
68
(61 to 72)
67
(58 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
Female
1
  14.3%
2
  33.3%
3
  23.1%
Male
6
  85.7%
4
  66.7%
10
  76.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 6 participants 13 participants
7 6 13
1.Primary Outcome
Title Disease-free Survival (DFS)
Hide Description The DFS hazard rate and 95% confidence interval will be reported. At this time, event time distributions for disease-free survival in the two arms will be estimated with the method of Kaplan and Meier and compared using a stratified Cox-proportional hazards model (stratified for stage IA vs IB) with a two-sided alpha of 10%.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early due to poor accrual since the requirement of clinic administration of the 5AZA daily and post-operative patients not wanting 6 months of treatment. Data was not collected to assess this outcome measure.
Arm/Group Title Arm I (Azacitidine, Entinostat) Arm II (Standard of Care)
Hide Arm/Group Description:

Patients receive azacitidine SC on days 1-5 and 8-10 and entinostat PO QD on days 3 and 10. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Azacitidine: Given SC

Entinostat: Given PO

Laboratory Biomarker Analysis: Correlative studies

Patients receive standard of care.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Factors That Predict Clinical Outcome in Patients Treated With Combination Epigenetic Therapy in Terms of Epigenomic Data Generated From the Illumina Platform
Hide Description The study was terminated early due to poor accrual since the requirement of clinic administration of the 5AZA daily and post-operative patients not wanting 6 months of treatment. For this reason, 13 pts were enrolled and data was not analyzed, for which we are unable to make any conclusions or report results.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early due to poor accrual since the requirement of clinic administration of the 5AZA daily and post-operative patients not wanting 6 months of treatment. Data was not collected to assess this outcome measure.
Arm/Group Title Azacitidine SC and Entinostat Oral Chemotherapy Alone
Hide Arm/Group Description:
Patients receive azacitidine SC on days 1-5 and 8-10 and entinostat PO QD on days 3 and 10. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Standard of care chemotherapy
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Median Disease-free Survival
Hide Description Determined by the method determined by Kaplan and Meier. Estimated with 95% confidence intervals. Cox proportional hazard modeling will be used for multivariate analysis.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early due to poor accrual since the requirement of clinic administration of the 5AZA daily and post-operative patients not wanting 6 months of treatment. Data was not collected to assess this outcome measure.
Arm/Group Title Azacitidine SC and Entinostat Oral Chemotherapy Alone
Hide Arm/Group Description:
Patients receive azacitidine SC on days 1-5 and 8-10 and entinostat PO QD on days 3 and 10. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Standard of care chemotherapy
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Number of Relapses and Deaths Per Total Time of Follow-up Comparing Patients With N2 Lymph Nodes in Terms of Methylated and Unmethylated
Hide Description Kaplan Meier curves will be used.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early due to poor accrual since the requirement of clinic administration of the 5AZA daily and post-operative patients not wanting 6 months of treatment. Data was not collected to assess this outcome measure.
Arm/Group Title Azacitidine SC and Entinostat Oral Chemotherapy Alone
Hide Arm/Group Description:
Patients receive azacitidine SC on days 1-5 and 8-10 and entinostat PO QD on days 3 and 10. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Standard of care chemotherapy
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Overall Survival
Hide Description Determined by the method determined by Kaplan and Meier. Estimated with 95% confidence intervals. Cox proportional hazard modeling will be used for multivariate analysis.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early due to poor accrual since the requirement of clinic administration of the 5AZA daily and post-operative patients not wanting 6 months of treatment. Data was not collected to assess this outcome measure.
Arm/Group Title Azacitidine SC and Entinostat PO Cytotoxic Therapy
Hide Arm/Group Description:
Patients receive azacitidine SC on days 1-5 and 8-10 and entinostat PO QD on days 3 and 10. Followed by Cytotoxic Therapy investigator Choice
Standard of care
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Presence of Methylation Patterns
Hide Description McNemar’s test will be used to compare the change in methylation after treatment in sputum.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early due to poor accrual since the requirement of clinic administration of the 5AZA daily and post-operative patients not wanting 6 months of treatment. Data was not collected to assess this outcome measure.
Arm/Group Title Azacitidine SC and Entinostat Oral Chemotherapy Alone
Hide Arm/Group Description:
Patients receive azacitidine SC on days 1-5 and 8-10 and entinostat PO QD on days 3 and 10. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Standard of care chemotherapy
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Toxicities Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
Hide Description Simple descriptive statistics will be utilized to display the data.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early due to poor accrual since the requirement of clinic administration of the 5AZA daily and post-operative patients not wanting 6 months of treatment. Data was not collected to assess this outcome measure.
Arm/Group Title Azacitidine SC and Entinostat Oral Chemotherapy Alone
Hide Arm/Group Description:
Patients receive azacitidine SC on days 1-5 and 8-10 and entinostat PO QD on days 3 and 10. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Standard of care chemotherapy
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Azacitidine SC and Entinostat PO Cytotoxic Chemotherapy
Hide Arm/Group Description Patients receive azacitidine SC on days 1-5 and 8-10 and entinostat PO QD on days 3 and 10. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Investigators Choice Chemotherapy
All-Cause Mortality
Azacitidine SC and Entinostat PO Cytotoxic Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/6 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Azacitidine SC and Entinostat PO Cytotoxic Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Azacitidine SC and Entinostat PO Cytotoxic Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/6 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Charlie Rudin, MD
Organization: SKCCC
Phone: 646.888.4527
EMail: rudinc@mskcc.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01207726     History of Changes
Other Study ID Numbers: NCI-2012-02901
NCI-2012-02901 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NA_00038631
J1037 ( Other Identifier: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital )
8311 ( Other Identifier: CTEP )
P30CA006973 ( U.S. NIH Grant/Contract )
First Submitted: September 10, 2010
First Posted: September 23, 2010
Results First Submitted: April 12, 2017
Results First Posted: February 5, 2019
Last Update Posted: February 5, 2019