Trial Outcomes & Findings for A Phase II Study of Neo-Adjuvant Gemcitabine, Cisplatin and Bevacizumab in Stage IIIA (N2) Non-Squamous Cell Non-Small Cell Lung Cancer (NCT NCT00924209)
NCT ID: NCT00924209
Last Updated: 2018-11-30
Results Overview
Complete response is defined as a disappearance of all target lesions and was assessed by the RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
25 weeks
Results posted on
2018-11-30
Participant Flow
Participant milestones
| Measure |
Stage IIIA Lung Cancer Patients
Non-squamous cell non small cell lung cancer treated with 1250 mg/m\^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m\^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m\^2 intravenous, and 100 mg/m\^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase II Study of Neo-Adjuvant Gemcitabine, Cisplatin and Bevacizumab in Stage IIIA (N2) Non-Squamous Cell Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Stage IIIA Lung Cancer Patients
n=7 Participants
Non-squamous cell non small cell lung cancer treated with 1250 mg/m\^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m\^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m\^2 intravenous, and 100 mg/m\^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
55.76 years
STANDARD_DEVIATION 6.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 25 weeksPopulation: No goals were met because of low accrual for which the study was closed.
Complete response is defined as a disappearance of all target lesions and was assessed by the RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 38 monthsHere is the number of participants with adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. For the detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Stage IIIA Lung Cancer Patients
n=7 Participants
Non-squamous cell non small cell lung cancer treated with 1250 mg/m\^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m\^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m\^2 intravenous, and 100 mg/m\^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
|
|---|---|
|
Number of Participants With Serious and Non-Serious Adverse Events
|
7 Participants
|
SECONDARY outcome
Timeframe: The time between the first day of treatment to the day of disease progressionPopulation: No goals were met because of low accrual for which the study was closed.
Progression free survival is defined as the time between the first day of treatment to the day of disease progression. Progression will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Length of time a participant lives with disease following treatmentPopulation: No goals were met because of low accrual for which the study was closed.
Median survival is the length of time a participant lives with disease following treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The time between the first day of treatment to the day of deathPopulation: No goals were met because of low accrual for which the study was closed.
Overall survival is defined as the time between the first day of treatment to the day of death.
Outcome measures
Outcome data not reported
Adverse Events
Stage IIIA Lung Cancer Patients
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage IIIA Lung Cancer Patients
n=7 participants at risk
Non-squamous cell non small cell lung cancer treated with 1250 mg/m\^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m\^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m\^2 intravenous, and 100 mg/m\^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
|
|---|---|
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Gastrointestinal disorders
Diarrhea
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
14.3%
1/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, embolism )
|
28.6%
2/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Nervous system disorders
Seizure
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
14.3%
1/7 • Number of events 4 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
Other adverse events
| Measure |
Stage IIIA Lung Cancer Patients
n=7 participants at risk
Non-squamous cell non small cell lung cancer treated with 1250 mg/m\^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m\^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m\^2 intravenous, and 100 mg/m\^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
|
|---|---|
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Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
28.6%
2/7 • Number of events 5 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
14.3%
1/7 • Number of events 4 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
28.6%
2/7 • Number of events 10 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Investigations
CPK (creatine phosphokinase)
|
14.3%
1/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Cardiac disorders
Cardiac troponin I (cTnI)
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Cardiac disorders
Cardiac troponin I (cTnT)
|
14.3%
1/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Hepatobiliary disorders
cholecystitis
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Investigations
Creatinine
|
14.3%
1/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Investigations
Hemoglobin
|
28.6%
2/7 • Number of events 14 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Vascular disorders
Hypotension
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Cardiac disorders
left ventricular systolic dysfunction
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Investigations
Leukocytes
|
85.7%
6/7 • Number of events 10 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Investigations
Lymphopenia
|
28.6%
2/7 • Number of events 5 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)::Oral cavity
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Gastrointestinal disorders
Nausea
|
57.1%
4/7 • Number of events 10 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
85.7%
6/7 • Number of events 17 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Investigations
PTT (Partial Thromboplastin Time)
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Gastrointestinal disorders
Pain::Abdomen NOS
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Musculoskeletal and connective tissue disorders
Pain: Back
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Musculoskeletal and connective tissue disorders
Pain::Chest wall
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
14.3%
1/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Vascular disorders
Phlebitis (including superficial thrombosis)
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
14.3%
1/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Investigations
Platelets
|
57.1%
4/7 • Number of events 9 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 38 months.
|
Additional Information
Caryn Steakley, Deputy Clinical Director
National Cancer Institute, National Institutes of Health
Phone: 240-858-3749
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place