Trial Outcomes & Findings for Novel Capecitabine Dosing Schedule in Combination With Lapatinib, Based on the Norton-Simon Mathematical Method in Patients With HER2 Overexpressed/Amplified, Trastuzumab (Herceptin) -Refractory, Metastatic Breast Cancer (NCT NCT00721630)
NCT ID: NCT00721630
Last Updated: 2017-08-15
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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) = CR + PR
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
6 months
Results posted on
2017-08-15
Participant Flow
Protocol Open to Accrual 7/10/2008, Protocol Closed to Accrual 7/27/2010, Primary Completion Date 7/14/2016, Recruitment location is the medical clinic
Participant milestones
| Measure |
Capecitabine + Lapatinib
The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.
capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week).
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Capecitabine + Lapatinib
The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.
capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week).
|
|---|---|
|
Overall Study
Participant found to be ineligible
|
1
|
Baseline Characteristics
Novel Capecitabine Dosing Schedule in Combination With Lapatinib, Based on the Norton-Simon Mathematical Method in Patients With HER2 Overexpressed/Amplified, Trastuzumab (Herceptin) -Refractory, Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Capecitabine + Lapatinib
n=24 Participants
The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.
capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week).
|
|---|---|
|
Age, Continuous
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 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
|
0 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
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 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
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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) = CR + PR
Outcome measures
| Measure |
Capecitabine + Lapatinib
n=23 Participants
The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.
capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week).
|
|---|---|
|
Estimate Efficacy of Capecitabine 7/7 in Combination With Lapatinib in Patients With HER2 Overexpressed/Amplified, Trastuzumab-refractory, Metastatic Breast Cancer as Determined by Overall Response Rate (Complete Response (CR) + Partial Response (PR))
Stable disease <6 months
|
11 Participants
|
|
Estimate Efficacy of Capecitabine 7/7 in Combination With Lapatinib in Patients With HER2 Overexpressed/Amplified, Trastuzumab-refractory, Metastatic Breast Cancer as Determined by Overall Response Rate (Complete Response (CR) + Partial Response (PR))
Partial Response
|
5 Participants
|
|
Estimate Efficacy of Capecitabine 7/7 in Combination With Lapatinib in Patients With HER2 Overexpressed/Amplified, Trastuzumab-refractory, Metastatic Breast Cancer as Determined by Overall Response Rate (Complete Response (CR) + Partial Response (PR))
Stable Disease >/= 6 months
|
6 Participants
|
|
Estimate Efficacy of Capecitabine 7/7 in Combination With Lapatinib in Patients With HER2 Overexpressed/Amplified, Trastuzumab-refractory, Metastatic Breast Cancer as Determined by Overall Response Rate (Complete Response (CR) + Partial Response (PR))
Progression of disease
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 monthsToxicities evaluated according to NCI CTC v.3
Outcome measures
| Measure |
Capecitabine + Lapatinib
n=23 Participants
The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.
capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week).
|
|---|---|
|
Number of Participants With Toxicities Associated With Capecitabine and Lapatinib
|
23 Participants
|
Adverse Events
Capecitabine + Lapatinib
Serious events: 9 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Capecitabine + Lapatinib
n=23 participants at risk
The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.
capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week).
|
|---|---|
|
Investigations
ALT
|
4.3%
1/23
|
|
Investigations
AST
|
4.3%
1/23
|
|
Nervous system disorders
Ataxia
|
8.7%
2/23
|
|
Psychiatric disorders
Confusion
|
4.3%
1/23
|
|
Gastrointestinal disorders
Diarrhea
|
4.3%
1/23
|
|
Injury, poisoning and procedural complications
Fracture
|
4.3%
1/23
|
|
Metabolism and nutrition disorders
Glucose, high
|
4.3%
1/23
|
|
Blood and lymphatic system disorders
Anemia
|
4.3%
1/23
|
|
Investigations
INR
|
4.3%
1/23
|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23
|
|
Nervous system disorders
Neurology - Other
|
4.3%
1/23
|
|
Investigations
PTT
|
4.3%
1/23
|
|
Musculoskeletal and connective tissue disorders
Limb Pain
|
4.3%
1/23
|
|
Skin and subcutaneous tissue disorders
Rash - hand-foot skin
|
4.3%
1/23
|
|
Nervous system disorders
Seizure
|
4.3%
1/23
|
|
Nervous system disorders
Syncope
|
4.3%
1/23
|
|
Vascular disorders
Thromboembolic event
|
4.3%
1/23
|
Other adverse events
| Measure |
Capecitabine + Lapatinib
n=23 participants at risk
The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.
capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week).
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
21.7%
5/23
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
69.6%
16/23
|
|
Gastrointestinal disorders
Diarrhea
|
82.6%
19/23
|
|
Hepatobiliary disorders
AST
|
69.6%
16/23
|
|
General disorders
Fatigue
|
65.2%
15/23
|
|
Hepatobiliary disorders
ALT
|
52.2%
12/23
|
|
Gastrointestinal disorders
Nausea
|
52.2%
12/23
|
|
Investigations
Alkaline Phosphatase
|
47.8%
11/23
|
|
Gastrointestinal disorders
Vomiting
|
34.8%
8/23
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
30.4%
7/23
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
30.4%
7/23
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
30.4%
7/23
|
|
Nervous system disorders
Sensory Neuropathy
|
30.4%
7/23
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
30.4%
7/23
|
|
Investigations
White blood cell decreased
|
26.1%
6/23
|
|
Gastrointestinal disorders
Mucositis - oral cavity
|
26.1%
6/23
|
|
Metabolism and nutrition disorders
Hypernatremia
|
26.1%
6/23
|
|
Investigations
Hyperbilirubinemia
|
21.7%
5/23
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.7%
5/23
|
|
Gastrointestinal disorders
Constipation
|
17.4%
4/23
|
|
Respiratory, thoracic and mediastinal disorders
Dyspena
|
17.4%
4/23
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
17.4%
4/23
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
17.4%
4/23
|
|
Investigations
Creatinine
|
13.0%
3/23
|
|
Nervous system disorders
Dizziness
|
13.0%
3/23
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
13.0%
3/23
|
|
Investigations
INR
|
13.0%
3/23
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
13.0%
3/23
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
13.0%
3/23
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
8.7%
2/23
|
|
Gastrointestinal disorders
Cheilitis
|
8.7%
2/23
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin, other
|
8.7%
2/23
|
|
General disorders
Fever (in the absence of neutropenia)
|
8.7%
2/23
|
|
Investigations
PTT
|
8.7%
2/23
|
|
Musculoskeletal and connective tissue disorders
Pain - joint
|
8.7%
2/23
|
|
General disorders
Pain - Other
|
8.7%
2/23
|
|
Investigations
Platelets
|
8.7%
2/23
|
|
Metabolism and nutrition disorders
Potassium, high
|
8.7%
2/23
|
|
Metabolism and nutrition disorders
Potassium, low
|
8.7%
2/23
|
|
Skin and subcutaneous tissue disorders
Pruritis/itching
|
8.7%
2/23
|
|
Reproductive system and breast disorders
Vaginal dryness
|
8.7%
2/23
|
Additional Information
Dr. Tiffany Traina
Memorial Sloan Kettering Cancer Center
Phone: 646-888-5209
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place