Trial Outcomes & Findings for S0338, Imatinib Mesylate and Capecitabine in Treating Women With Progressive Stage IV Breast Cancer (NCT NCT00087152)
NCT ID: NCT00087152
Last Updated: 2014-06-09
Results Overview
Number of participants with confirmed complete or partial response. Confirmed response (complete and partial) per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (V1.0). Complete Response (CR) is complete disappearance of all measurable and non-measurable disease; no new lesions; no disease related symptoms; and normalization of markers and other abnormal lab values. Partial response (PR) applies only to patients with at least one measurable lesion. PR is greater than or equal to 30% decrease under baseline of the sum of longest diameter of all target measurable lesions; no unequivocal progression of non-measurable disease and no new lesions. Confirmed response is two or more objective statuses a minimum of four weeks apart documented before progression or symptomatic deterioration.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
12 weeks
Results posted on
2014-06-09
Participant Flow
The study was activated June 15, 2004. It was open to SWOG institutions who obtained Institutional Review Board (IRB) approval for this study. 27 patients were enrolled at 16 institutions. The study was temporarily closed to accrual April 19, 2005 to allow assessment of response in the first stage. It was closed permanently on December 15, 2005.
Participant milestones
| Measure |
Imatinib Mesylate & Capecitabine
Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m\^2 by mouth twice daily Days 1-14 of each 21 day cycle.
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Imatinib Mesylate & Capecitabine
Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m\^2 by mouth twice daily Days 1-14 of each 21 day cycle.
|
|---|---|
|
Overall Study
Ineligible
|
6
|
Baseline Characteristics
S0338, Imatinib Mesylate and Capecitabine in Treating Women With Progressive Stage IV Breast Cancer
Baseline characteristics by cohort
| Measure |
Imatinib Mesylate & Capecitabine
n=27 Participants
Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m\^2 by mouth twice daily Days 1-14 of each 21 day cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
55.3 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Eligible participants who received treatment.
Number of participants with confirmed complete or partial response. Confirmed response (complete and partial) per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (V1.0). Complete Response (CR) is complete disappearance of all measurable and non-measurable disease; no new lesions; no disease related symptoms; and normalization of markers and other abnormal lab values. Partial response (PR) applies only to patients with at least one measurable lesion. PR is greater than or equal to 30% decrease under baseline of the sum of longest diameter of all target measurable lesions; no unequivocal progression of non-measurable disease and no new lesions. Confirmed response is two or more objective statuses a minimum of four weeks apart documented before progression or symptomatic deterioration.
Outcome measures
| Measure |
Imatinib Mesylate & Capecitabine
n=19 Participants
Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m\^2 by mouth twice daily Days 1-14 of each 21 day cycle.
|
|---|---|
|
Confirmed Response Rate (Complete and Partial)
|
2 participants
|
SECONDARY outcome
Timeframe: Six monthsPopulation: Eligible participants who received treatment.
Percentage of participants progression-free at 6 months. Progression-free survival (PFS) measured from date of registration to first observation of progressive disease (per RECIST criteria (V1.0)), death due to any cause, or symptomatic deterioration. Kaplan-Meier was used to estimate progression-free survival (PFS) at six months.
Outcome measures
| Measure |
Imatinib Mesylate & Capecitabine
n=19 Participants
Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m\^2 by mouth twice daily Days 1-14 of each 21 day cycle.
|
|---|---|
|
Progression-free Survival at 6 Months
|
16 percentage of participants
Interval 0.0 to 32.0
|
SECONDARY outcome
Timeframe: Every 3 weeks while on treatment for up to 3 years.Population: Eligible participants who received any treatment.
Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5= Fatal. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
Imatinib Mesylate & Capecitabine
n=20 Participants
Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m\^2 by mouth twice daily Days 1-14 of each 21 day cycle.
|
|---|---|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Diarrhea
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Fatigue (asthenia, lethargy, malaise)
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Leukocytes (total WBC)
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Mucositis/stomatitis (clinical exam) - Oral cavity
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Neuropathy: motor
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Neuropathy: sensory
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Neutrophils/granulocytes (ANC/AGC)
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain - Abdomen NOS
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain - Muscle
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Rash/desquamation
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Rash: hand-foot skin reaction
|
2 Participants
|
Adverse Events
Imatinib Mesylate and Capecitabine
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Imatinib Mesylate and Capecitabine
n=20 participants at risk
Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m\^2 by mouth twice daily Days 1-14 of each 21 day cycle.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Disease progression NOS
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
Other adverse events
| Measure |
Imatinib Mesylate and Capecitabine
n=20 participants at risk
Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m\^2 by mouth twice daily Days 1-14 of each 21 day cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
70.0%
14/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Eye disorders
Ocular/Visual-Other (Specify)
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Eye disorders
Optic disc edema
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
2/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Gastrointestinal disorders
Diarrhea
|
35.0%
7/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Gastrointestinal disorders
Gastrointestinal-Other (Specify)
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
10.0%
2/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Gastrointestinal disorders
Hemorrhage, GI - Stomach
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
20.0%
4/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Gastrointestinal disorders
Nausea
|
70.0%
14/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
15.0%
3/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
10/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
General disorders
Death not associated with CTCAE term - Death NOS
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
General disorders
Edema: head and neck
|
10.0%
2/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
General disorders
Edema: limb
|
30.0%
6/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
75.0%
15/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
10.0%
2/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Investigations
AST, SGOT
|
10.0%
2/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Investigations
Alkaline phosphatase
|
15.0%
3/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
15.0%
3/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Investigations
Leukocytes (total WBC)
|
20.0%
4/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
45.0%
9/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Investigations
Platelets
|
25.0%
5/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Investigations
Weight gain
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Investigations
Weight loss
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
10.0%
2/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
4/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
15.0%
3/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
10.0%
2/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
10.0%
2/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
25.0%
5/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Disease progression NOS
|
40.0%
8/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Nervous system disorders
Neuropathy: motor
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Nervous system disorders
Neuropathy: sensory
|
20.0%
4/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Nervous system disorders
Ocular/Visual-Other (Specify)
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Nervous system disorders
Pain - Head/headache
|
10.0%
2/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Psychiatric disorders
Confusion
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Psychiatric disorders
Mood alteration - anxiety
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Psychiatric disorders
Mood alteration - depression
|
10.0%
2/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
15.0%
3/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Edema, larynx
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
20.0%
4/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
30.0%
6/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Vascular disorders
Flushing
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
|
Vascular disorders
Hot flashes/flushes
|
5.0%
1/20 • Every 3 weeks while on treatment for up to 3 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60