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Trial record 7 of 125 for:    lapatinib | Recruiting, Active, not recruiting, Completed Studies | Phase 2

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

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ClinicalTrials.gov Identifier: NCT00721630
Recruitment Status : Completed
First Posted : July 24, 2008
Results First Posted : August 15, 2017
Last Update Posted : August 15, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Intervention Drug: capecitabine, lapatinib
Enrollment 24
Recruitment Details 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
Pre-assignment Details  
Arm/Group Title Capecitabine + Lapatinib
Hide Arm/Group Description

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).

Period Title: Overall Study
Started 24
Completed 23
Not Completed 1
Reason Not Completed
Participant found to be ineligible             1
Arm/Group Title Capecitabine + Lapatinib
Hide Arm/Group Description

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 Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 24 participants
54
(34 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
23
  95.8%
Male
1
   4.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Hispanic or Latino
2
   8.3%
Not Hispanic or Latino
22
  91.7%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
7
  29.2%
White
17
  70.8%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants
24
1.Primary Outcome
Title 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))
Hide Description 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
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Capecitabine + Lapatinib
Hide Arm/Group Description:

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 Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
Partial Response
5
  21.7%
Stable Disease >/= 6 months
6
  26.1%
Stable disease <6 months
11
  47.8%
Progression of disease
1
   4.3%
2.Secondary Outcome
Title Number of Participants With Toxicities Associated With Capecitabine and Lapatinib
Hide Description Toxicities evaluated according to NCI CTC v.3
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Capecitabine + Lapatinib
Hide Arm/Group Description:

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 Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
23
 100.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Capecitabine + Lapatinib
Hide Arm/Group Description

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).

All-Cause Mortality
Capecitabine + Lapatinib
Affected / at Risk (%)
Total   0/23 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Capecitabine + Lapatinib
Affected / at Risk (%)
Total   9/23 (39.13%) 
Blood and lymphatic system disorders   
Anemia   1/23 (4.35%) 
Gastrointestinal disorders   
Diarrhea   1/23 (4.35%) 
Nausea   1/23 (4.35%) 
Injury, poisoning and procedural complications   
Fracture   1/23 (4.35%) 
Investigations   
ALT   1/23 (4.35%) 
AST   1/23 (4.35%) 
INR   1/23 (4.35%) 
PTT   1/23 (4.35%) 
Metabolism and nutrition disorders   
Glucose, high   1/23 (4.35%) 
Musculoskeletal and connective tissue disorders   
Limb Pain   1/23 (4.35%) 
Nervous system disorders   
Ataxia   2/23 (8.70%) 
Neurology - Other   1/23 (4.35%) 
Seizure   1/23 (4.35%) 
Syncope   1/23 (4.35%) 
Psychiatric disorders   
Confusion   1/23 (4.35%) 
Skin and subcutaneous tissue disorders   
Rash - hand-foot skin   1/23 (4.35%) 
Vascular disorders   
Thromboembolic event   1/23 (4.35%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Capecitabine + Lapatinib
Affected / at Risk (%)
Total   23/23 (100.00%) 
Blood and lymphatic system disorders   
Anemia   5/23 (21.74%) 
Gastrointestinal disorders   
Diarrhea   19/23 (82.61%) 
Nausea   12/23 (52.17%) 
Vomiting   8/23 (34.78%) 
Mucositis - oral cavity   6/23 (26.09%) 
Constipation   4/23 (17.39%) 
Cheilitis   2/23 (8.70%) 
General disorders   
Fatigue   15/23 (65.22%) 
Fever (in the absence of neutropenia)   2/23 (8.70%) 
Pain - Other   2/23 (8.70%) 
Hepatobiliary disorders   
AST   16/23 (69.57%) 
ALT   12/23 (52.17%) 
Investigations   
Alkaline Phosphatase   11/23 (47.83%) 
White blood cell decreased   6/23 (26.09%) 
Hyperbilirubinemia   5/23 (21.74%) 
Creatinine   3/23 (13.04%) 
INR   3/23 (13.04%) 
PTT   2/23 (8.70%) 
Platelets   2/23 (8.70%) 
Metabolism and nutrition disorders   
Hypoalbuminemia   7/23 (30.43%) 
Hyperglycemia   7/23 (30.43%) 
Hypernatremia   6/23 (26.09%) 
Potassium, high   2/23 (8.70%) 
Potassium, low   2/23 (8.70%) 
Musculoskeletal and connective tissue disorders   
Pain in extremity   4/23 (17.39%) 
Pain - Back   3/23 (13.04%) 
Arthritis (non-septic)   2/23 (8.70%) 
Pain - joint   2/23 (8.70%) 
Nervous system disorders   
Sensory Neuropathy   7/23 (30.43%) 
Dizziness   3/23 (13.04%) 
Reproductive system and breast disorders   
Vaginal dryness   2/23 (8.70%) 
Respiratory, thoracic and mediastinal disorders   
Cough   5/23 (21.74%) 
Dyspena   4/23 (17.39%) 
Skin and subcutaneous tissue disorders   
Palmar-plantar erythrodysesthesia syndrome   16/23 (69.57%) 
Dry Skin   7/23 (30.43%) 
Rash/desquamation   7/23 (30.43%) 
Nail changes   4/23 (17.39%) 
Hyperpigmentation   3/23 (13.04%) 
Rash: acne/acneiform   3/23 (13.04%) 
Dermatology/Skin, other   2/23 (8.70%) 
Pruritis/itching   2/23 (8.70%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Tiffany Traina
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-888-5209
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00721630     History of Changes
Other Study ID Numbers: 08-025
First Submitted: July 22, 2008
First Posted: July 24, 2008
Results First Submitted: June 13, 2017
Results First Posted: August 15, 2017
Last Update Posted: August 15, 2017