Trial Outcomes & Findings for Gemcitabine +/- Imatinib Mesylate, Patients w/Previously Treated Metastatic Breast Cancer (NCT NCT00323063)
NCT ID: NCT00323063
Last Updated: 2023-03-29
Results Overview
Sample size of 40 patients per group was needed to detect an 8 month increase in time to progression with the combination (80% power, alpha =.05, 2-sided).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
5 years
Results posted on
2023-03-29
Participant Flow
This study was opened to accural on 5/1/2006 and was closed to accrual on 4/15/2011 due to slow accrual. Subjects were recruited through the Cancer Institute of New Jersey Oncology Group. We are reporting results on 49 eligible patients. One was not eligible for participation.
Participant milestones
| Measure |
Gemcitabine Hydrochloride
Patients receive gemcitabine hydrochloride 1250 mg/m2 intravenously on days 3 and 10.
gemcitabine hydrochloride: Given IV
|
Gemcitabine Hydrochloride + Imatinib
Patients receive gemcitabine hydrochloride 1250 mg/m2 intravenously on days 3 and 10 and oral imatinib mesylate 400 mg orally once daily on days 1-5 and 8-12.
gemcitabine hydrochloride: Given IV
imatinib mesylate: Given orally
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
23
|
|
Overall Study
COMPLETED
|
24
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Gemcitabine Hydrochloride
Patients receive gemcitabine hydrochloride 1250 mg/m2 intravenously on days 3 and 10.
gemcitabine hydrochloride: Given IV
|
Gemcitabine Hydrochloride + Imatinib
Patients receive gemcitabine hydrochloride 1250 mg/m2 intravenously on days 3 and 10 and oral imatinib mesylate 400 mg orally once daily on days 1-5 and 8-12.
gemcitabine hydrochloride: Given IV
imatinib mesylate: Given orally
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
brain mets discovered prior to treatment
|
1
|
0
|
Baseline Characteristics
Gemcitabine +/- Imatinib Mesylate, Patients w/Previously Treated Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm I
n=26 Participants
Patients receive gemcitabine hydrochloride 1250 mg/m2 intravenously on days 3 and 10.
gemcitabine hydrochloride: Given IV
|
Arm II
n=23 Participants
Patients receive gemcitabine hydrochloride 1250 mg/m2 intravenously on days 3 and 10 and oral imatinib mesylate 400 mg orally once daily on days 1-5 and 8-12.
gemcitabine hydrochloride: Given IV
imatinib mesylate: Given orally
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Continuous
|
60.7 years
n=5 Participants
|
62.4 years
n=7 Participants
|
61.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
23 participants
n=7 Participants
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsSample size of 40 patients per group was needed to detect an 8 month increase in time to progression with the combination (80% power, alpha =.05, 2-sided).
Outcome measures
| Measure |
Arm I (Gemcitabine Hydrochloride)
n=26 Participants
Patients receive gemcitabine hydrochloride IV on days 3 and 10.
gemcitabine hydrochloride: Given IV
|
Arm II (Gemcitabine Hydrochloride + Imatinib)
n=23 Participants
Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12.
gemcitabine hydrochloride: Given IV
imatinib mesylate: Given orally
|
|---|---|---|
|
Time to Progression
|
2 months
Interval 1.0 to 5.0
|
2.5 months
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: 5 yearsOverall response rate was evaluated every 2 cycles (six weeks) for both groups using international criteria by the Response Evaluation Criteria in Solid Tumors (RECISTv1.0) for target lesions and were assessed by CT or MRI. Response rates were defined as complete response (CR), disappearance of all target lesions; partial response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Overall response(OR) defined as OR=CR + PR
Outcome measures
| Measure |
Arm I (Gemcitabine Hydrochloride)
n=26 Participants
Patients receive gemcitabine hydrochloride IV on days 3 and 10.
gemcitabine hydrochloride: Given IV
|
Arm II (Gemcitabine Hydrochloride + Imatinib)
n=23 Participants
Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12.
gemcitabine hydrochloride: Given IV
imatinib mesylate: Given orally
|
|---|---|---|
|
Response Rate (Complete and Partial Response)
|
9.1 percentage of participants
Interval 1.6 to 30.6
|
9.1 percentage of participants
Interval 1.6 to 30.6
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: This study was prematurely closed so overall survival was not analyzed.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Gemcitabine Hydrochloride)
Serious events: 5 serious events
Other events: 26 other events
Deaths: 0 deaths
Arm II (Gemcitabine Hydrochloride + Imatinib)
Serious events: 6 serious events
Other events: 23 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm I (Gemcitabine Hydrochloride)
n=26 participants at risk
Patients receive gemcitabine hydrochloride 1250 mg/m2 intravenously on days 3 and 10.
gemcitabine hydrochloride: Given IV
|
Arm II (Gemcitabine Hydrochloride + Imatinib)
n=23 participants at risk
Patients receive gemcitabine hydrochloride 1250 mg/m2 intravenously on days 3 and 10 and oral imatinib mesylate 400 mg orally once daily on days 1-5 and 8-12.
gemcitabine hydrochloride: Given IV
imatinib mesylate: Given orally
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
7.7%
2/26 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/26
|
4.3%
1/23 • Number of events 1
|
|
Investigations
Neutrophils decreased
|
0.00%
0/26
|
4.3%
1/23 • Number of events 1
|
|
Investigations
Anemia
|
0.00%
0/26
|
4.3%
1/23 • Number of events 1
|
|
Infections and infestations
Lung Infection
|
0.00%
0/26
|
4.3%
1/23 • Number of events 1
|
|
General disorders
Fever
|
7.7%
2/26 • Number of events 2
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
2/26 • Number of events 2
|
8.7%
2/23 • Number of events 2
|
Other adverse events
| Measure |
Arm I (Gemcitabine Hydrochloride)
n=26 participants at risk
Patients receive gemcitabine hydrochloride 1250 mg/m2 intravenously on days 3 and 10.
gemcitabine hydrochloride: Given IV
|
Arm II (Gemcitabine Hydrochloride + Imatinib)
n=23 participants at risk
Patients receive gemcitabine hydrochloride 1250 mg/m2 intravenously on days 3 and 10 and oral imatinib mesylate 400 mg orally once daily on days 1-5 and 8-12.
gemcitabine hydrochloride: Given IV
imatinib mesylate: Given orally
|
|---|---|---|
|
Investigations
alkaline phosphatase increased
|
3.8%
1/26 • Number of events 2
|
0.00%
0/23
|
|
Investigations
Alanine aminotransferase
|
15.4%
4/26 • Number of events 5
|
4.3%
1/23 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
7.7%
2/26 • Number of events 2
|
4.3%
1/23 • Number of events 2
|
|
General disorders
Fatigue
|
38.5%
10/26 • Number of events 16
|
17.4%
4/23 • Number of events 14
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
30.8%
8/26 • Number of events 8
|
34.8%
8/23 • Number of events 8
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
13/26 • Number of events 31
|
34.8%
8/23 • Number of events 40
|
|
Investigations
White blood cell decreased
|
53.8%
14/26 • Number of events 30
|
30.4%
7/23 • Number of events 39
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/26
|
4.3%
1/23 • Number of events 2
|
|
Investigations
Neutrophil count decreased
|
76.9%
20/26 • Number of events 45
|
43.5%
10/23 • Number of events 57
|
|
Investigations
Platelet count decreased
|
26.9%
7/26 • Number of events 16
|
21.7%
5/23 • Number of events 20
|
|
Gastrointestinal disorders
Vomiting
|
19.2%
5/26 • Number of events 6
|
13.0%
3/23 • Number of events 11
|
|
Gastrointestinal disorders
Nausea
|
34.6%
9/26 • Number of events 12
|
21.7%
5/23 • Number of events 17
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/26
|
4.3%
1/23 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
7.7%
2/26 • Number of events 3
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
1/26 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Vascular disorders
Hot flashes
|
3.8%
1/26 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Investigations
Aspartate aminoransferase elevated
|
0.00%
0/26
|
4.3%
1/23 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/26
|
4.3%
1/23 • Number of events 1
|
|
General disorders
Fever
|
19.2%
5/26 • Number of events 5
|
4.3%
1/23 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.7%
2/26 • Number of events 2
|
4.3%
1/23 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/26
|
4.3%
1/23 • Number of events 3
|
|
Gastrointestinal disorders
Mucositis oral
|
3.8%
1/26 • Number of events 1
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
1/26 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
3.8%
1/26 • Number of events 1
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
1/26 • Number of events 1
|
0.00%
0/23
|
|
Investigations
Creatinine increased
|
0.00%
0/26
|
4.3%
1/23 • Number of events 1
|
|
Eye disorders
Dry eye
|
0.00%
0/26
|
4.3%
1/23 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/26
|
4.3%
1/23 • Number of events 1
|
|
Infections and infestations
Lung Infection
|
0.00%
0/26
|
4.3%
1/23 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place