Trial Outcomes & Findings for Gemcitabine and Imatinib Mesylate in Treating Patients With Recurrent or Metastatic Non-Small Cell Lung Cancer (NCT NCT00323362)
NCT ID: NCT00323362
Last Updated: 2014-05-22
Results Overview
Response is considered Partial Response or Complete Response as per RECIST criteria. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
2 years
Results posted on
2014-05-22
Participant Flow
Seventeen patients were enrolled from April 2006 through October 2007 at Rutgers Cancer Institute of New Jersey, a comprehensive cancer cancert, and two of its affiliate hospitals within the CINJ Oncology Group.
Participant milestones
| Measure |
Gemcitabine Hydrochloride and Imatinib Mesylate
gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.
imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gemcitabine and Imatinib Mesylate in Treating Patients With Recurrent or Metastatic Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine Hydrochloride and Imatinib Mesylate
n=17 Participants
gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.
imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Fourteen subjects were evaluable for response. Three subjects were not assessed.
Response is considered Partial Response or Complete Response as per RECIST criteria. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
Gemcitabine Hydrochloride and Imatinib Mesylate
n=14 Participants
gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.
imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days
|
|---|---|
|
Percentage of Patients Who Meet Critieria for Response
|
0 percentage of patients who responded
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The study was closed early due to toxicity and insufficient data were collected to analyze this outcome measure.
Outcome measures
| Measure |
Gemcitabine Hydrochloride and Imatinib Mesylate
n=14 Participants
gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.
imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days
|
|---|---|
|
Time to Progression
|
2.77 months
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The study was closed early due to toxicity and insufficient data were collected to analyze this outcome measure.
Accrual duration is 2 years with an additional year for assessment of 1-year survival. Outcome measure time frame is about 3 years.
Outcome measures
| Measure |
Gemcitabine Hydrochloride and Imatinib Mesylate
n=17 Participants
gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.
imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days
|
|---|---|
|
1-year Survival
|
35 percentage of patients
|
Adverse Events
Gemcitabine Hydrochloride and Imatinib Mesylate
Serious events: 10 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine Hydrochloride and Imatinib Mesylate
n=17 participants at risk
gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.
imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Platelets
|
11.8%
2/17 • Number of events 2 • 2 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Vascular disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
17.6%
3/17 • Number of events 3 • 2 years
|
|
General disorders
Death not associated with CTCAE term - Disease progression NOS
|
23.5%
4/17 • Number of events 4 • 2 years
|
|
General disorders
Other toxicity
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
17.6%
3/17 • Number of events 3 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Confusion
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)
|
11.8%
2/17 • Number of events 2 • 2 years
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.9%
1/17 • Number of events 2 • 2 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS
|
5.9%
1/17 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Gemcitabine Hydrochloride and Imatinib Mesylate
n=17 participants at risk
gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.
imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days
|
|---|---|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
64.7%
11/17 • Number of events 27 • 2 years
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
64.7%
11/17 • Number of events 30 • 2 years
|
|
Blood and lymphatic system disorders
Platelets
|
52.9%
9/17 • Number of events 13 • 2 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
47.1%
8/17 • Number of events 15 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
52.9%
9/17 • Number of events 11 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
41.2%
7/17 • Number of events 7 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
17.6%
3/17 • Number of events 3 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
11.8%
2/17 • Number of events 2 • 2 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
47.1%
8/17 • Number of events 9 • 2 years
|
|
General disorders
Insomnia
|
11.8%
2/17 • Number of events 2 • 2 years
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
General disorders
Weight loss
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
General disorders
Pain - Bone
|
23.5%
4/17 • Number of events 4 • 2 years
|
|
General disorders
Pain - Head/headache
|
11.8%
2/17 • Number of events 3 • 2 years
|
|
General disorders
Pain - Muscle
|
11.8%
2/17 • Number of events 3 • 2 years
|
|
General disorders
Pain - Back
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
General disorders
Pain - Extremity-limb
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
General disorders
Pain - Joint
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
General disorders
Pain - other
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
29.4%
5/17 • Number of events 7 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
11.8%
2/17 • Number of events 3 • 2 years
|
|
Gastrointestinal disorders
Anorexia
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
11.8%
2/17 • Number of events 2 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)
|
11.8%
2/17 • Number of events 2 • 2 years
|
|
Infections and infestations
Infection - Other
|
5.9%
1/17 • Number of events 3 • 2 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
|
5.9%
1/17 • Number of events 2 • 2 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Infections and infestations
Infection with unknown ANC - Skin (cellulitis)
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Nervous system disorders
Neuropathy: sensory
|
11.8%
2/17 • Number of events 2 • 2 years
|
|
Psychiatric disorders
Confusion
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Mood alteration - Anxiety
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Mood alteration - Depression
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Vascular disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
11.8%
2/17 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary NOS
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Vascular disorders
Hemorrhage/Bleeding - Other
|
5.9%
1/17 • Number of events 2 • 2 years
|
|
Blood and lymphatic system disorders
Edema: limb
|
17.6%
3/17 • Number of events 7 • 2 years
|
|
Renal and urinary disorders
Bladder spasms
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Incontinence, urinary
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Cardiac disorders
Hypotension
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
General disorders
Death not associated with CTCAE term - Disease progression NOS
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Investigations
Potassium, serum-low (hypokalemia)
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Vascular disorders
Vascular - Other
|
5.9%
1/17 • Number of events 1 • 2 years
|
Additional Information
Dr. Joseph Aisner, MD
Rutgers Cancer Institute of New Jersey
Phone: 732-235-8675
Results disclosure agreements
- Principal investigator is a sponsor employee The CINJ PI, and all co-authors, prior to submission or use, must review any abstract or manuscript.
- Publication restrictions are in place
Restriction type: OTHER