Trial Outcomes & Findings for Lapatinib and Radiation for Stage III-IV Head and Neck Cancer Patients Who Cannot Tolerate Concurrent Chemotherapy (NCT NCT00490061)

Results Overview

To determine the efficacy of combining lapatinib and radiotherapy in terms of Progression-free survival (PFS) in patients with locally advanced HNSCC who cannot tolerate concurrent chemoradiotherapy. Progression-free survival is defined is the time from starting treatment to the time of first documented tumor progression or death due to any cause, which ever occurs first. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST V1.0) as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

2 year PFS: PFS at 2 yrs after study enrollment

Results posted on

2017-03-06

Participant Flow

Recruitment took place in a radiation oncology clinic, in a private room. The recruitment period spanned from 7/26/2007-11/18/2011.

\# of subjects were screened.

Participant milestones

Participant milestones
Measure	Radiotherapy (Radiation) and Lapatinib Lapatinib, 1500mg once daily, was administered for 7 days prior to, and for the duration of Intensity Modulated Radio Therapy (IMRT), delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.
Overall Study STARTED	17
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Radiotherapy (Radiation) and Lapatinib Lapatinib, 1500mg once daily, was administered for 7 days prior to, and for the duration of Intensity Modulated Radio Therapy (IMRT), delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.
Overall Study Physician Decision	1

Baseline Characteristics

Lapatinib and Radiation for Stage III-IV Head and Neck Cancer Patients Who Cannot Tolerate Concurrent Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiotherapy (Radiation) and Lapatinib n=16 Participants 1500mg/d once daily oral lapatinib administration plus Intensity Modulated Radio Therapy (IMRT) delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks. Lapatinib: 1500 mg po daily orally Radiotherapy (radiation): Standard of Care G.E. Healthcare 1.5T MR, systems revision 12.0 M5: Standard of Care, used to deliver IMRT PET/CT: A subset of patients received imaging before and after treatment.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Gender Female	5 Participants n=5 Participants
Gender Male	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 year PFS: PFS at 2 yrs after study enrollment

Population: All enrolled participants.

To determine the efficacy of combining lapatinib and radiotherapy in terms of Progression-free survival (PFS) in patients with locally advanced HNSCC who cannot tolerate concurrent chemoradiotherapy. Progression-free survival is defined is the time from starting treatment to the time of first documented tumor progression or death due to any cause, which ever occurs first. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST V1.0) as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Outcome measures

Outcome measures
Measure	Radiotherapy (Radiation) and Lapatinib n=16 Participants Lapatinib, 1500mg once daily, was administered for 7 days prior to, and for the duration of Intensity Modulated Radio Therapy (IMRT), delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.
Progression Free Survival	56.2 percentage of participants Interval 47.0 to 65.0

SECONDARY outcome

Timeframe: Two years survival rate after study enrollment

Population: All enrolled participants.

Overall survival is the time from starting treatment until death due to any cause. For subjects who do not die, time to death will be censored at the time of last contact.

Outcome measures

Outcome measures
Measure	Radiotherapy (Radiation) and Lapatinib n=16 Participants Lapatinib, 1500mg once daily, was administered for 7 days prior to, and for the duration of Intensity Modulated Radio Therapy (IMRT), delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.
Overall Survival.	62.5 percentage of participants

Adverse Events

Radiotherapy (Radiation) and Lapatinib

Serious events: 6 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Radiotherapy (Radiation) and Lapatinib n=16 participants at risk Lapatinib, 1500mg once daily, was administered for 7 days prior to, and for the duration of Intensity Modulated Radio Therapy (IMRT), delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.
Respiratory, thoracic and mediastinal disorders Edema, larynx	6.2% 1/16 • Number of events 1 • 2 years acute and late AE assessed at follow up appointments
Vascular disorders Thrombosis/Thrombus/Embolism	6.2% 1/16 • Number of events 1 • 2 years acute and late AE assessed at follow up appointments
Blood and lymphatic system disorders Hemolysis	6.2% 1/16 • Number of events 1 • 2 years acute and late AE assessed at follow up appointments
Investigations ALT Increased	6.2% 1/16 • Number of events 1 • 2 years acute and late AE assessed at follow up appointments
Immune system disorders Lymphopenia	6.2% 1/16 • Number of events 1 • 2 years acute and late AE assessed at follow up appointments
Metabolism and nutrition disorders Hyponatermia	6.2% 1/16 • Number of events 1 • 2 years acute and late AE assessed at follow up appointments

Other adverse events

Other adverse events
Measure	Radiotherapy (Radiation) and Lapatinib n=16 participants at risk Lapatinib, 1500mg once daily, was administered for 7 days prior to, and for the duration of Intensity Modulated Radio Therapy (IMRT), delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.
Investigations Elevated ALT	12.5% 2/16 • Number of events 2 • 2 years acute and late AE assessed at follow up appointments
Investigations Elevated AST	18.8% 3/16 • Number of events 3 • 2 years acute and late AE assessed at follow up appointments
Investigations Elevated ALK	12.5% 2/16 • Number of events 2 • 2 years acute and late AE assessed at follow up appointments
Respiratory, thoracic and mediastinal disorders Aspiration pneumonia	6.2% 1/16 • Number of events 1 • 2 years acute and late AE assessed at follow up appointments
Metabolism and nutrition disorders Dehydration	6.2% 1/16 • Number of events 1 • 2 years acute and late AE assessed at follow up appointments
Gastrointestinal disorders diarrhea	6.2% 1/16 • Number of events 1 • 2 years acute and late AE assessed at follow up appointments
Metabolism and nutrition disorders Hyponatremia	6.2% 1/16 • Number of events 1 • 2 years acute and late AE assessed at follow up appointments

Additional Information

Quynh Le

Stanford University

Phone: 650-498-5032

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place