Quynh-Thu Le
Phase II Lapatinib and Radiation for Stage III-IV Head and Neck Cancer Patients Who Cannot Tolerate Concurrent Chemotherapy
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
We propose to combine lapatinib with RT alone in patients with locally advanced head and neck cancer who cannot tolerate chemotherapy. The main objective of the study is to determine the efficacy of combining concurrent radiation and lapatinib in terms of time-to-progression (TTP) in this group of patients. In addition, we will determine the 2-year locoregional control rate (LRC), progression-free survival (PFS) and overall survival (OS) in these patients. We will also evaluate the profile and frequency of late toxicity, specifically mucosal and dermatologic toxicity, of the combination of lapatinib and RT in patients with locally advanced head and neck squamous cell carcinoma (HNSCC).
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Lapatinib
- Procedure: Radiotherapy
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- Newly diagnosed stage III-IV HNSCC, pathologically confirmed (HNSCC from unknown primary sites are allowed)
- No evidence of distant metastasis
- No prior radiation therapy to the head and neck sites.
- Able to sign a study-specific informed consent form.
- Women of childbearing potential and men with partners capable of producing offspring must be willing to practice acceptable methods of birth control to prevent pregnancy.
- Left ventricular ejection fraction (LVEF) within the institutional normal range as measured by ECHO (If ECHO cannot be performed or if the Investigator feels that it is not conclusive to evaluate LVEF, then a MUGA scan should be performed).
- Having one of the following parameters that would preclude the use of concurrent CRT:
o ECOG PS > 2.
o Creatinine > 1.3 or calculate or measure creatinine clearance < 60 ml/min.
o AST or ALT > 1.5 times normal limit but < 3 times normal limit
o Total bilirubin > 1.5 mg/dL but < 3mg/dL
o History of hearing loss that would preclude cisplatin chemotherapy. These would include the existing need of a hearing aid or a >= 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test.
o Pre-existing peripheral neuropathy that would preclude cisplatin chemotherapy
o Refuse or cannot tolerate chemotherapy
- Age 18 years or older
Key Exclusion Criteria:
- Known hypersensitivity to lapatinib or any of the excipients of this product (quinazolines).
- Uncontrolled angina, arrhythmia or congestive heart failure at the time of HNSCC diagnosis and treatment.
- History of myocardial infarction < 6 months from study entry.
- Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
- Prior treatment with EGFR or Her2/Neu directed therapies.
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with Lapatinib.
- Absolute neutrophil count < 1500/uL
Additional Study Details
Official Title:
A Multi-Institutional Phase II Study of Radiation and GW572016 (Lapatinib) for Patients with Stage III-IV Head and Neck Cancer Who Cannot Tolerate Concurrent Chemoradiotherapy.Anticipated start date:
7/26/2007Lead Sponsor:
Stanford UniversityCollaborator(s):
- GlaxoSmithKline
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
EfficacyPrimary Outcomes:
- Efficacy of combining lapatinib and radiotherapy in terms of time to progression (TTP) in patients with locally advanced HNSCC who cannot tolerate concurrent chemoradiotherapy
Secondary Outcomes:
- 2-year locoregional control, progression free survival and over all survival rates in these patients
- Rate and pattern of late-treatment related toxicity in these patients
- Role of DCE MRI in predicting treatment outcomes in treated patients
- Changes in the expression of relevant tumoral and circulating biomarkers
- Change in quality of life status relative to baseline
Total Number to be Enrolled:
60Total Number to be Enrolled at Stanford:
20More Information
Secondary ID(s):
- 97864
- ENT0020
- LAP #109855
- NCT00490061
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
8/19/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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