Description:
PURPOSE: This trial is studying if and how well lapatinib adds to the effectiveness of
radiation therapy plus cisplatin in patients who have head and neck cancer that is not
related to the HPV virus.
Title
- Brief Title: TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer.
- Official Title: TRYHARD: A Phase II, Randomized, Double Blind, Placebo-Controlled Study of Lapatinib (Tykerb®) for Non-HPV Locally Advanced Head and Neck Cancer With Concurrent Chemoradiation
Clinical Trial IDs
- ORG STUDY ID:
RF-3501
- SECONDARY ID:
LAP116153
- NCT ID:
NCT01711658
Conditions
- Non-HPV Locally Advanced Head and Neck Cancer
Interventions
Drug | Synonyms | Arms |
---|
Cisplatin | | Radiation therapy (IMRT) + cisplatin + lapatinib |
placebo | | Radiation therapy (IMRT) + cisplatin + placebo |
Lapatinib | | Radiation therapy (IMRT) + cisplatin + lapatinib |
Purpose
PURPOSE: This trial is studying if and how well lapatinib adds to the effectiveness of
radiation therapy plus cisplatin in patients who have head and neck cancer that is not
related to the HPV virus.
Trial Arms
Name | Type | Description | Interventions |
---|
Radiation therapy (IMRT) + cisplatin + placebo | Placebo Comparator | Radiation therapy: Intensity Modulated Radiation Therapy (IMRT) + cisplatin + placebo | |
Radiation therapy (IMRT) + cisplatin + lapatinib | Active Comparator | Radiation therapy: Intensity Modulated Radiation Therapy (IMRT) + cisplatin + lapatinib | |
Eligibility Criteria
Inclusion criteria:
- Patients must have histologically or cytologically confirmed diagnosis (from primary
lesion and/or lymph nodes) of Squamous Cell Cancer of the oropharynx, hypopharynx or
larynx (For patients with oropharynx primary, the tumor must be negative for p16 by
immunohistochemistry).
- Patients with selected Stage III or IV disease (T2 N2-3 M0, T3-4 any N M0, T1 N2b, N2c
or N3p16 negative oropharynx cancer or T1-2 any N hypopharynx cancer) including no
distant metastases.
- History/Physical examination by a Radiation Oncologist and Medical oncologist prior to
entering the study.
- Examination by an ENT or Head & Neck Surgeon including laryngopharyngoscopy prior to
entering the study.
- Patients must have a chest CT scan, or PET/CT scan to rule out metastatic disease
- Patients must have a contrast enhanced CT scan or MRI or PET/CT scan of the tumor site
and neck nodes prior to entering the study.
- Patients must have an EKG and ECHO or MUGA scan prior to entering the study.
- Patients must have Zubrod Performance Status of 0-1.
- Patients must be ≥ 18 years of age.
- Patients must have normal organ and marrow function as defined below:
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- Platelets ≥ 100,000 cells/mm3
- Hemoglobin ≥ 8.0 g/dl
- Serum creatinine < 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min
- Total bilirubin < 2 x the institutional upper limit of normal
- AST or ALT ≤ 3 x the institutional upper limit of normal
- Patient must have magnesium, calcium, glucose, potassium and sodium levels within
normal limits
- Women of childbearing potential must have a negative pregnancy test prior to
registration.
- Patients of reproductive potential must practice effective contraception while on
study and for at least 60 calendar days following treatment.
- All patients must sign an informed consent prior to enrollment.
- Patients must comply with the treatment plan and follow-up schedule.
Exclusion criteria:
- Patients with simultaneous primaries or bilateral tumors.
- Patients who have had gross total excision of the primary tumor.
- Patients with initial surgical treatment, radical or modified neck dissection.
- Patients who received prior systemic chemotherapy for the study cancer.
- Patients who received prior radiotherapy to the region of the study cancer that would
result in overlap of radiation therapy fields.
- Patients with primary tumor of oral cavity, nasopharynx, sinuses or salivary glands.
- Prior allergic reaction to the study drugs.
- Patients who have had prior therapy that specifically and directly targets the
EGFR/HER2 pathway.
- Patients who have current active hepatic or biliary disease (with exception of
patients with Gilbert's syndrome, asymptomatic gallstones, or stable chronic liver
disease per investigator assessment);
- Pregnant women or sexually active patients not willing or able to use medically
acceptable forms of contraceptive method while on treatment.
- Patients with severe, active co-morbidity, defined as follows:
- Uncontrolled cardiac disease, such as uncontrolled hypertension, unstable angina,
and/or congestive heart failure requiring hospitalization within the last 6
months
- Transmural myocardial infarction within the last 6 months
- Left ventricular ejection fraction < 45%
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time
of registration
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy within 30 calendar days
prior to registration
- Hepatic insufficiency resulting in clinical jaundice and/or Coagulation defects
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression-Free survival |
Time Frame: | 2 years |
Safety Issue: | |
Description: | The time from randomization until local, regional, or distant disease progression, or death. |
Secondary Outcome Measures
Measure: | Distant metastasis |
Time Frame: | 2 years |
Safety Issue: | |
Description: | The time from randomization until development of distant metastasis. |
Measure: | Adverse Events |
Time Frame: | Participants are followed for up to 8 months from the start of treatment |
Safety Issue: | |
Description: | Data is collected during protocol treatment and 30 days after whether or not related to the study drug. |
Measure: | Compliance with planned treatment |
Time Frame: | maintenance therapy is 3 months and could be different for each patient. |
Safety Issue: | |
Description: | |
Measure: | Local-regional failure |
Time Frame: | 2 years |
Safety Issue: | |
Description: | The time from randomization until local-regional recurrence or progression. |
Measure: | Performance Status Scale for Head & Neck Cancer. |
Time Frame: | 3 months, 1 year, and 2 years |
Safety Issue: | |
Description: | |
Measure: | Functional Assessment of Cancer Therapy - Head & Neck. |
Time Frame: | 3 months, 1 year, and 2 years. |
Safety Issue: | |
Description: | |
Measure: | University of Michigan Xerostomia-Related Quality of Life Scale. |
Time Frame: | 3 months, 1 year, and 2 years. |
Safety Issue: | |
Description: | |
Measure: | HER2, EGFR, EMT as biomarkers of response. |
Time Frame: | End of Study |
Safety Issue: | |
Description: | |
Measure: | Overall Survival |
Time Frame: | 2 years |
Safety Issue: | |
Description: | The time from randomization until death |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Radiation Therapy Oncology Group |
Last Updated
December 3, 2020