Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01209520
Recruitment Status : Completed
First Posted : September 27, 2010
Results First Posted : February 24, 2015
Last Update Posted : February 24, 2015
Sponsor:
Information provided by (Responsible Party):
Ikechukwu Akunyili, University of Miami

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lung Cancer
Non Small Cell Lung Carcinoma
Hypermethylation
Interventions Drug: Cisplatin
Drug: Carboplatin
Drug: Paclitaxel
Drug: Vidaza
Procedure: Tumor Specimen for Methylation Analysis
Procedure: Blood Sample for Methylation Analysis
Drug: Vinorelbine
Drug: Docetaxel
Drug: Pemetrexed
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adjuvant Chemotherapy + Vidaza
Hide Arm/Group Description

Cisplatin: 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: 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: 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: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles

Period Title: Overall Study
Started 6
Completed 3
Not Completed 3
Reason Not Completed
Withdrawal by Subject             3
Arm/Group Title Adjuvant Chemotherapy + Vidaza
Hide Arm/Group Description

Cisplatin: 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: 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: 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: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles

Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
  33.3%
>=65 years
4
  66.7%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants
74.5
(61 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
4
  66.7%
Male
2
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title 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.
Hide Description To determine the feasibility and efficacy of incorporating a demethylating agent (5-azacitidine; Vidaza®, Celgene, Summit, NJ, USA) as part of adjuvant therapy in patients diagnosed with NSCLC who harbor methylated tumor supressor genes (TSGs) in their tumor tissue and/or serum. Response to be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.0.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study data were not analyzed due to insufficient number of evaluable patients.
Arm/Group Title Adjuvant Chemotherapy + Vidaza
Hide Arm/Group Description:

Cisplatin: 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: 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: 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: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Degree of Demethylation in Patient Tumor Tissue and/or Serum Induced by 5-azacitidine on Specific Tumor Specific Genes (TSGs)
Hide Description To measure the grade of demethylation induced by 5-azaciditine on specific TSGs by analyzing plasma DNA, and global demethylation by analyzing WBC DNA, and determine the duration of this effect.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study data were not analyzed due to insufficient number of evaluable patients.
Arm/Group Title Adjuvant Chemotherapy + Vidaza
Hide Arm/Group Description:

Cisplatin: 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: 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: 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: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adjuvant Chemotherapy + Vidaza
Hide Arm/Group Description

Cisplatin: 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: 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: 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: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles

All-Cause Mortality
Adjuvant Chemotherapy + Vidaza
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Adjuvant Chemotherapy + Vidaza
Affected / at Risk (%) # Events
Total   1/6 (16.67%)    
Cardiac disorders   
Sinus tachycardia  1/6 (16.67%)  1
General disorders   
Fever  1/6 (16.67%)  1
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adjuvant Chemotherapy + Vidaza
Affected / at Risk (%) # Events
Total   5/6 (83.33%)    
Blood and lymphatic system disorders   
Edema - limbs  1/6 (16.67%)  1
Edema - head and neck  1/6 (16.67%)  1
Hemolysis  1/6 (16.67%)  2
Petechiae  1/6 (16.67%)  1
Thrombosis/thrombus/embolism  1/6 (16.67%)  1
Gastrointestinal disorders   
Anorexia  1/6 (16.67%)  1
Constipation  2/6 (33.33%)  2
Dehydration  1/6 (16.67%)  1
Diarrhea  2/6 (33.33%)  4
Large intestinal mucositis  1/6 (16.67%)  1
Nausea  3/6 (50.00%)  4
General disorders   
Abdominal Pain  1/6 (16.67%)  1
Bone pain  1/6 (16.67%)  1
Fatigue  2/6 (33.33%)  4
Joint pain  1/6 (16.67%)  2
Weight loss  1/6 (16.67%)  1
Infections and infestations   
Bronchitis  1/6 (16.67%)  1
Metabolism and nutrition disorders   
Creatinine increased  1/6 (16.67%)  5
Hypomagnesemia  1/6 (16.67%)  1
Nervous system disorders   
Neurology - other  1/6 (16.67%)  1
Peripheral sensory neuropathy  2/6 (33.33%)  2
Renal and urinary disorders   
Urine discoloration  1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  2/6 (33.33%)  2
Dyspnea  3/6 (50.00%)  3
Skin and subcutaneous tissue disorders   
Alopecia  2/6 (33.33%)  2
Dermatology - Skin, other  1/6 (16.67%)  2
Rash  1/6 (16.67%)  2
Taste alteration  1/6 (16.67%)  1
1
Term from vocabulary, CTCAE (3.0)
Study data were not analyzed due to insufficient number of evaluable patients.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ikechukwu Akunyili MD
Organization: University of Miami
Phone: 305-243-6626
EMail: IAkunyili@med.miami.edu
Layout table for additonal information
Responsible Party: Ikechukwu Akunyili, University of Miami
ClinicalTrials.gov Identifier: NCT01209520    
Other Study ID Numbers: 20080779
SCCC-2008045 ( Other Identifier: University of Miami Sylvester Comprehensive Cancer Center )
First Submitted: September 22, 2010
First Posted: September 27, 2010
Results First Submitted: January 9, 2015
Results First Posted: February 24, 2015
Last Update Posted: February 24, 2015