Trial Outcomes & Findings for Residual Hypermethylation in Early Stage Non-Small Cell Lung Cancer (NSCLC) As Part of Adjuvant Therapy and Preventive Strategy (NCT NCT01209520)
NCT ID: NCT01209520
Last Updated: 2015-02-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2015-02-24
Participant Flow
Participant milestones
| Measure |
Adjuvant Chemotherapy + Vidaza
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 Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Adjuvant Chemotherapy + Vidaza
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 Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Residual Hypermethylation in Early Stage Non-Small Cell Lung Cancer (NSCLC) As Part of Adjuvant Therapy and Preventive Strategy
Baseline characteristics by cohort
| Measure |
Adjuvant Chemotherapy + Vidaza
n=6 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
74.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Study data were not analyzed due to insufficient number of evaluable patients.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Study data were not analyzed due to insufficient number of evaluable patients.
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.
Outcome measures
Outcome data not reported
Adverse Events
Adjuvant Chemotherapy + Vidaza
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adjuvant Chemotherapy + Vidaza
n=6 participants at risk
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
|
|---|---|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 1
|
Other adverse events
| Measure |
Adjuvant Chemotherapy + Vidaza
n=6 participants at risk
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
|
|---|---|
|
General disorders
Abdominal Pain
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
2/6 • Number of events 2
|
|
Gastrointestinal disorders
Anorexia
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Bone pain
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Creatinine increased
|
16.7%
1/6 • Number of events 5
|
|
Gastrointestinal disorders
Dehydration
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatology - Skin, other
|
16.7%
1/6 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
3/6 • Number of events 3
|
|
Blood and lymphatic system disorders
Edema - limbs
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
Edema - head and neck
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 4
|
|
Blood and lymphatic system disorders
Hemolysis
|
16.7%
1/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Joint pain
|
16.7%
1/6 • Number of events 2
|
|
Gastrointestinal disorders
Large intestinal mucositis
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Number of events 4
|
|
Nervous system disorders
Neurology - other
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
2/6 • Number of events 2
|
|
Blood and lymphatic system disorders
Petechiae
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Taste alteration
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombosis/thrombus/embolism
|
16.7%
1/6 • Number of events 1
|
|
Renal and urinary disorders
Urine discoloration
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Weight loss
|
16.7%
1/6 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place