Trial Search Results

Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer

This phase II/III trial studies how well radiation therapy works when given together with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous cell). Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to compare the usual treatment (radiation therapy with cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy, and using the usual treatment plus an immunotherapy drug, atezolizumab.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

National Cancer Institute (NCI)

Collaborator: NRG Oncology

Intervention(s):

  • Drug: Atezolizumab
  • Biological: Cetuximab
  • Drug: Cisplatin
  • Drug: Docetaxel
  • Radiation: Intensity-Modulated Radiation Therapy
  • Other: Laboratory Biomarker Analysis
  • Other: Quality-of-Life Assessment

Phase:

Phase 2/Phase 3

Eligibility


Inclusion Criteria:

   - PHASE II INCLUSION CRITERIA (COMPLETE AS OF 20-MAR-2020)

   - Pathologically (histologically or cytologically) proven diagnosis of head and neck
   squamous cell carcinoma (HNSCC) involving the oral cavity (excluding lips), oropharynx
   (p16 negative), larynx, or hypopharynx

   - Patients must have undergone gross total surgical resection of high-risk oral cavity,
   oropharynx (p16 negative), larynx, or hypopharynx within 63 days prior to
   registration; Note: patients may have biopsy under general anesthesia in an operating
   room followed by definitive ablative cancer surgery representing gross total
   resection; the gross total resection has to be done within 63 days prior to
   registration; if, however, patients have ablative resection but shortly recur or are
   determined to have persisting disease requiring re-resection to achieve gross total
   resection, then the patient is not eligible

   - Patients must have at least 1 of the following high-risk pathologic features:
   extracapsular nodal extension or invasive cancer at the primary tumor resection margin
   (tumor on ink)

   - Pathologic stage III or IV HNSCC, including no distant metastases, based upon the
   following minimum diagnostic workup:

      - General history and physical examination by a radiation oncologist and/or medical
      oncologist within 84 days prior to registration;

      - Examination by an ear nose throat (ENT) or head & neck surgeon prior to surgery;
      a laryngopharyngoscopy (mirror and/or fiber optic and/or direct procedure), if
      appropriate, is recommended but not required; intra-operative examination is
      acceptable documentation

      - Pre-operative (op) Imaging of the head and neck: A neck computed tomography (CT)
      (with contrast) or CT/positron emission tomography (PET) (with contrast) and/or
      an magnetic resonance imaging (MRI) of the neck (T1 with gadolinium and T2)
      within 84 days prior to surgery; Note: this imaging data (diagnostic
      pre-operative scan showing gross disease) is to be submitted in Digital Imaging
      and Communications in Medicine (DICOM) format via TRIAD; the report is to be
      uploaded into Rave

      - Chest CT scan (with or without contrast) or CT/PET that includes the chest (with
      or without contrast) either within 84 days prior to surgery or within 120 days
      prior to registration; Note: if the CT/PET with or without contrast is done
      within 84 days prior to surgery, it fulfills the chest imaging requirement

   - Zubrod performance status of 0-1 within 14 days prior to registration

   - Absolute granulocyte count (AGC) >= 1,500 cells/mm^3 (obtained within 14 days prior to
   registration on study)

   - Platelets >= 100,000 cells/mm^3 (obtained within 14 days prior to registration on
   study)

   - Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve
   hemoglobin [Hgb] >= 8.0 g/dl is acceptable)

   - Total bilirubin < 2 x institutional upper limit of normal (ULN) within 14 days prior
   to registration

   - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x institutional
   ULN within 14 days prior to registration

   - Serum creatinine institutional ULN within 14 days prior to registration or; creatinine
   clearance (CC) >= 50 ml/min within 14 days prior to registration determined by 24-hour
   collection or estimated by Cockcroft-Gault formula

   - Negative urine or serum pregnancy test within 14 days prior to registration for women
   of childbearing potential

   - The following assessments are required within 14 days prior to registration: sodium
   (Na), potassium (K), chloride (Cl), glucose, calcium (Ca), magnesium (Mg), and
   albumin; Note: patients with an initial magnesium < 0.5 mmol/L (1.2 mg/dl) may receive
   corrective magnesium supplementation but should continue to receive either
   prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (e.g.,
   magnesium oxide) at the investigator's discretion

   - Patients with feeding tubes are eligible for the study

   - Women of childbearing potential and male participants who are sexually active must
   agree to use a medically effective means of birth control

   - Patient must provide study specific informed consent prior to study entry, including
   consent for mandatory tissue submission for epidermal growth factor receptor (EGFR)
   analysis and for oropharyngeal cancer patients, human papilloma virus (HPV) analysis

   - PHASE III: Pathologically (histologically or cytologically) proven diagnosis of head
   and neck squamous cell carcinoma (HNSCC) involving the oral cavity (excluding lips),
   oropharynx (p16 negative), larynx, or hypopharynx

   - PHASE III: Patients with oropharyngeal cancer must have p16-negative based on central
   review prior to Step 2 registration; all patients with oropharyngeal primary must
   consent for mandatory tissue submission for central p16 confirmation

   - PHASE III: Patients must have undergone gross total surgical resection of high-risk
   oral cavity, oropharynx (p16 negative), larynx, or hypopharynx within 63 days prior to
   registration; note: patients may have biopsy under general anesthesia in an operating
   room followed by definitive ablative cancer surgery representing gross total
   resection; the gross total resection has to be done within 63 days prior to
   registration; if, however, patients have ablative resection but shortly recur or are
   determined to have persisting disease requiring re-resection to achieve gross total
   resection, then the patient is not eligible

   - PHASE III: Patients must have at least 1 of the following high-risk pathologic
   features: extracapsular nodal extension or invasive cancer at the primary tumor
   resection margin (tumor on ink or tumor in a final separately submitted margin)

   - PHASE III: Pathologic stage III or IV HNSCC (American Joint Committee on Cancer [AJCC]
   7th edition), including no distant metastases, based upon the following minimum
   diagnostic workup:

      - General history and physical examination by a radiation oncologist or medical
      oncologist within 84 days prior to registration;

      - Examination by an ENT or head & neck surgeon prior to surgery; a
      laryngopharyngoscopy (mirror or fiberoptic or direct procedure), if appropriate,
      is recommended but not required. Intra-operative examination is acceptable
      documentation.

      - Pre-op Imaging of the head and neck: A neck CT (with contrast and of diagnostic
      quality) or PET/CT (with contrast and of diagnostic quality) and/or an MRI of the
      neck of diagnostic quality (T1 with gadolinium and T2) within 84 days prior to
      surgery; Note: this imaging data (diagnostic pre-operative scan showing gross
      disease) is to be submitted in DICOM format via TRIAD. The report is to be
      uploaded into Rave.

      - Chest CT scan (with or without contrast) or PET/CT that includes the chest (with
      or without contrast) either within 84 days prior to surgery or within 120 days
      prior to registration; Note: If the PET/CT with or without contrast is done
      within 84 days prior to surgery, it fulfills the chest imaging requirement

   - PHASE III: Zubrod performance status of 0-1 within 14 days prior to registration

   - PHASE III: Leukocytes >= 2,500 cells/mm^3 (obtained within 14 days prior to
   registration on study)

   - PHASE III: Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (obtained within 14
   days prior to registration on study)

   - PHASE III: Platelets >= 100,000 cells/mm^3 (obtained within 14 days prior to
   registration on study)

   - PHASE III: Hemoglobin >= 8.0 g/dL (Note: The use of transfusion or other intervention
   to achieve Hgb >= 8.0 g/dL is acceptable) (obtained within 14 days prior to
   registration on study)

   - PHASE III: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
   (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x
   institutional ULN may be enrolled) (within 14 days prior to registration)

   - PHASE III: AST or ALT =< 3 x institutional ULN (within 14 days prior to registration)

   - PHASE III: Alkaline phosphatase =< 2.5 x institutional ULN (within 14 days prior to
   registration)

   - PHASE III: Creatinine clearance (CrCl) >= 50 mL/min within 14 days prior to
   registration determined by 24-hour collection or estimated by Cockcroft-Gault formula

   - PHASE III: Patients with feeding tubes are eligible for the study

   - PHASE III: Negative urine or serum pregnancy test within 14 days prior to registration
   for women of childbearing potential

   - PHASE III: All patients must provide study specific informed consent prior to study
   entry

   - PHASE III: Patients positive for human immunodeficiency virus (HIV) are allowed on
   study, but HIV-positive patients must have:

      - A stable regimen of highly active anti-retroviral therapy (HAART);

      - No requirement for concurrent antibiotics or antifungal agents for the prevention
      of opportunistic infections;

      - A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard
      polymerase chain reaction (PCR)-based tests

Exclusion Criteria:

   - PHASE II EXCLUSION CRITERIA (COMPLETE AS OF 20-MAR-2020)

   - Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
   for a minimum of 1095 days (3 years); noninvasive cancers (for example, carcinoma in
   situ of the breast, oral cavity, or cervix are all permissible) are permitted even if
   diagnosed and treated < 3 years ago

   - Patients with simultaneous primaries or bilateral tumors are excluded, with the
   exception of patients with bilateral tonsil cancers or patients with T1-2, N0, M0
   resected differentiated thyroid carcinoma, who are eligible

   - Prior systemic chemotherapy or anti-epidermal growth factor (EGF) therapy for the
   study cancer; note that prior chemotherapy for a different cancer is allowable

   - Prior radiotherapy to the region of the study cancer that would result in overlap of
   radiation therapy fields

   - Severe, active co-morbidity, defined as follows:

      - Unstable angina and/or congestive heart failure requiring hospitalization within
      6 months prior to registration

      - Transmural myocardial infarction within 6 months prior to registration

      - 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 at the time of registration

         - Idiopathic pulmonary fibrosis or other severe interstitial lung disease that
         requires oxygen therapy or is thought to require oxygen therapy within 1
         year prior to registration

      - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
      note, however, that laboratory tests for coagulation parameters are not required
      for entry into this protocol

         - Acquired immune deficiency syndrome (AIDS) based upon current Centers for
         Disease and Control and Prevention (CDC) definition; note: human
         immunodeficiency virus (HIV) testing is not required for entry into this
         protocol; the need to exclude patients with AIDS from this protocol is
         necessary because the treatments involved in this protocol may be
         significantly immunosuppressive; protocol-specific requirements may also
         exclude immuno-compromised patients.

   - Grade 3-4 electrolyte abnormalities (Common Terminology Criteria for Adverse Events
   [CTCAE], version [v.] 4):

   - Serum calcium (ionized or adjusted for albumin) < 7 mg/dl (1.75 mmol/L) or > 12.5
   mg/dl (> 3.1 mmol/L) despite intervention to normalize levels

   - Glucose < 40 mg/dl (< 2.2 mmol/L) or > 250 mg/dl (> 14 mmol/L)

   - Magnesium < 0.9 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention
   to normalize levels

   - Potassium < 3.0 mmol/L or > 6 mmol/L despite intervention to normalize levels

   - Sodium < 130 mmol/L or > 155 mmol/L despite intervention to normalize levels

   - Pregnancy or women of childbearing potential and men who are sexually active and not
   willing/able to use medically acceptable forms of contraception; this exclusion is
   necessary because the treatment involved in this study may be significantly
   teratogenic

   - Prior allergic reaction to cetuximab

   - PHASE III: Prior invasive malignancy (except non-melanomatous skin cancer) unless
   disease free for a minimum of 1095 days (3 years) with the following exceptions: T1-2,
   N0, M0 resected differentiated thyroid carcinoma; Note that noninvasive cancers (For
   example, carcinoma in situ of the breast, oral cavity, or cervix) are permitted even
   if diagnosed and treated < 3 years ago

   - PHASE III: Patients with simultaneous primaries or bilateral tumors are excluded, with
   the exception of patients with bilateral tonsil cancers or patients with T1-2, N0, M0
   resected differentiated thyroid carcinoma, who are eligible

   - PHASE III: Prior systemic therapy, including cytotoxic chemotherapy, biologic/targeted
   therapy (such as anti-EGF therapy), or immune therapy for the study cancer; note that
   prior chemotherapy for a different cancer is allowable, however, a prior anti-PD-1,
   anti-PD-L1, or anti-PD-L2 agent is not permitted

   - PHASE III: Prior radiotherapy to the region of the study cancer that would result in
   overlap of radiation therapy fields

   - PHASE III: Severe, active co-morbidity, defined as follows:

      - Patients with known history or current symptoms of cardiac disease, or history of
      treatment with cardiotoxic agents, should have a clinical risk assessment of
      cardiac function using the New York Heart Association Functional Classification;
      to be eligible for this trial, patients should be class 2B or better within 6
      months prior to registration

      - Transmural myocardial infarction within 6 months prior to registration;

      - Severe infections within 4 weeks prior to registration including, but not limited
      to, hospitalization for complications of infection, bacteremia, or severe
      pneumonia;

      - Acute bacterial or fungal infection requiring intravenous antibiotics at the time
      of registration; Note: Patients receiving prophylactic antibiotics (e.g., for
      prevention of a urinary tract infection or chronic obstructive pulmonary disease
      exacerbation) are eligible.

      - Chronic obstructive pulmonary disease exacerbation or other respiratory illness
      requiring hospitalization or precluding study therapy at the time of
      registration;

      - History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced),
      organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing
      pneumonia, etc.), or evidence of active pneumonitis on screening chest computed
      tomography (CT) scan. History of radiation pneumonitis in a prior radiation field
      (fibrosis) is permitted, provided that field does not overlap with the planned
      radiation field for the study cancer;

      - Patients with active tuberculosis (TB) are excluded;

      - Known clinically significant liver disease, including active viral, alcoholic, or
      other hepatitis; cirrhosis; fatty liver; and inherited liver disease;

         - Patients with past or resolved hepatitis B infection (defined as having a
         negative hepatitis B surface ant

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting