Clinical Trials /

TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer.

NCT01711658

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.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
CisplatinRadiation therapy (IMRT) + cisplatin + lapatinib
placeboRadiation therapy (IMRT) + cisplatin + placebo
LapatinibRadiation 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

NameTypeDescriptionInterventions
Radiation therapy (IMRT) + cisplatin + placeboPlacebo ComparatorRadiation therapy: Intensity Modulated Radiation Therapy (IMRT) + cisplatin + placebo
  • Cisplatin
  • placebo
Radiation therapy (IMRT) + cisplatin + lapatinibActive ComparatorRadiation therapy: Intensity Modulated Radiation Therapy (IMRT) + cisplatin + lapatinib
  • 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