Trial Outcomes & Findings for Capecitabine and Lapatinib Ditosylate in Treating Patients With Squamous Cell Cancer of the Head and Neck (NCT NCT01044433)

NCT ID: NCT01044433

Last Updated: 2020-03-19

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 44 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2020-03-19

Participant Flow

Participant milestones

Measure	Lapatinib Ditosylate and Capecitabine Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14. lapatinib ditosylate: Given orally capecitabine: Given orally
Overall Study STARTED	44
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Lapatinib Ditosylate and Capecitabine Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14. lapatinib ditosylate: Given orally capecitabine: Given orally
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Capecitabine and Lapatinib Ditosylate in Treating Patients With Squamous Cell Cancer of the Head and Neck

Baseline characteristics by cohort

Measure	Lapatinib Ditosylate and Capecitabine n=44 Participants Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14. lapatinib ditosylate: Given orally capecitabine: Given orally
Age, Continuous	62 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 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	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Outcome measures

Measure	Lapatinib Ditosylate and Capecitabine n=44 Participants Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14. lapatinib ditosylate: Given orally capecitabine: Given orally
Overall Survival	10.7 Months Interval 8.7 to 12.9

SECONDARY outcome

Timeframe: 5 years

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.

Outcome measures

Measure	Lapatinib Ditosylate and Capecitabine n=44 Participants Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14. lapatinib ditosylate: Given orally capecitabine: Given orally
Response Rate	25 percentage Interval 15.0 to 38.0

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Measure	Lapatinib Ditosylate and Capecitabine n=44 Participants Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14. lapatinib ditosylate: Given orally capecitabine: Given orally
Disease Control Rate	68 percentage Interval 55.0 to 80.0

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Measure	Lapatinib Ditosylate and Capecitabine n=44 Participants Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14. lapatinib ditosylate: Given orally capecitabine: Given orally
Progression-free Survival	4.2 months Interval 3.6 to 5.1

SECONDARY outcome

Timeframe: 5 years

ADVERSE EVENTS (AE) AND SERIOUS ADVERSE EVENTS (SAE) Adverse Events (AEs) will use the descriptions and grading scales found in the NCI CTCAE v3.0

Outcome measures

Measure	Lapatinib Ditosylate and Capecitabine n=44 Participants Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14. lapatinib ditosylate: Given orally capecitabine: Given orally
Number of Participants With Adverse Events and Serious Adverse Events Pain	26 Participants
Number of Participants With Adverse Events and Serious Adverse Events Diarrhea	31 Participants
Number of Participants With Adverse Events and Serious Adverse Events Rash	31 Participants
Number of Participants With Adverse Events and Serious Adverse Events Fatigue	23 Participants
Number of Participants With Adverse Events and Serious Adverse Events Infection	19 Participants
Number of Participants With Adverse Events and Serious Adverse Events Nausea	19 Participants
Number of Participants With Adverse Events and Serious Adverse Events Mucositis	14 Participants
Number of Participants With Adverse Events and Serious Adverse Events Vomiting	13 Participants
Number of Participants With Adverse Events and Serious Adverse Events Constipation	10 Participants
Number of Participants With Adverse Events and Serious Adverse Events Hand-foot syndrome	8 Participants
Number of Participants With Adverse Events and Serious Adverse Events Cough	7 Participants
Number of Participants With Adverse Events and Serious Adverse Events Acute kidney injury	6 Participants
Number of Participants With Adverse Events and Serious Adverse Events Dry skin	6 Participants
Number of Participants With Adverse Events and Serious Adverse Events Anorexia	6 Participants
Number of Participants With Adverse Events and Serious Adverse Events Dehydration	5 Participants
Number of Participants With Adverse Events and Serious Adverse Events Edema of limb	5 Participants
Number of Participants With Adverse Events and Serious Adverse Events Heartburn	5 Participants
Number of Participants With Adverse Events and Serious Adverse Events Hyponatremia	5 Participants
Number of Participants With Adverse Events and Serious Adverse Events Neuropathy	5 Participants
Number of Participants With Adverse Events and Serious Adverse Events Neutropenia	2 Participants
Number of Participants With Adverse Events and Serious Adverse Events Febrile	1 Participants

Adverse Events

Lapatinib Ditosylate and Capecitabine

Serious events: 44 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lapatinib Ditosylate and Capecitabine n=44 participants at risk Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14. lapatinib ditosylate: Given orally capecitabine: Given orally
Gastrointestinal disorders Diarrhea	70.5% 31/44
Endocrine disorders Rash	70.5% 31/44
General disorders Pain	59.1% 26/44
General disorders Fatigue	52.3% 23/44
Infections and infestations Infection	43.2% 19/44
Gastrointestinal disorders Nausea	43.2% 19/44
Gastrointestinal disorders Mucositis	31.8% 14/44
Gastrointestinal disorders Vomiting	29.5% 13/44
Gastrointestinal disorders Constipation	22.7% 10/44
Skin and subcutaneous tissue disorders Hand-foot syndrome	18.2% 8/44
Respiratory, thoracic and mediastinal disorders Cough	15.9% 7/44
Renal and urinary disorders Acute kidney injury	13.6% 6/44
Skin and subcutaneous tissue disorders Dry skin	13.6% 6/44
Metabolism and nutrition disorders Anorexia	13.6% 6/44
Metabolism and nutrition disorders Dehydration	11.4% 5/44
Vascular disorders Edema of limb	11.4% 5/44
Gastrointestinal disorders Heartburn	11.4% 5/44
Metabolism and nutrition disorders Hyponatremia	11.4% 5/44
Nervous system disorders Neuropathy	11.4% 5/44
Blood and lymphatic system disorders Neutropenia	11.4% 5/44
Blood and lymphatic system disorders Febrile	2.3% 1/44

Other adverse events

Adverse event data not reported

Additional Information

Dr. Corey Langer

Abramson Cancer Center

Phone: 215-615-5121

Email: Corey.Langer@uphs.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place