Phase 2 Study to Evaluate the Pharmacokinetics and Drug-Drug Interaction of Cetuximab and Cisplatin in Patients With Recurrent or Metastatic Carcinoma of the Head and Neck
- The participant has histologically or cytologically confirmed head and neck cancer,
with the exception of lymphomas involving the head and neck region. Tumors of unknown
origin presenting in the head and neck region or local or recurrent skin cancers in
the head and neck region are also acceptable.
- The participant has measurable or non-measurable disease.
- If the patient has received prior treatment with anti-EGFR therapy, the time to
recurrence from the last cetuximab or other anti-EGFR agent exposure is > 90 days. If
the patient has received therapy with an anti-EGFR tyrosine kinase inhibitor, the
time to recurrence from the last exposure is > 30 days.
- The participant has a life expectancy of greater than 3 months.
- The participant has an Eastern Cooperative Oncology Group (ECOG) performance status
of 0, 1, or 2.
- The participant has adequate hematologic function as defined by absolute neutrophil
count greater than or equal to 1500/microliter (μL), hemoglobin greater than or equal
to 9 grams/deciliter (g/dL), and platelet count greater than or equal to
- The participant has adequate hepatic function as defined by a total bilirubin less
than or equal to 2 x the upper limit of normal (ULN), aspartate transaminase (AST,
SGOT) and alanine transaminase (ALT, SGPT) less than or equal to 3 x the ULN (or less
than or equal to 5 x the ULN in the presence of known liver metastases).
- The participant has adequate renal function as defined by serum creatinine less than
or equal to 1.5 x the institutional ULN or creatinine clearance greater than or equal
to 60 mL/min for participants with creatinine levels above the ULN.
- The participant has the ability to understand, and the willingness to sign, a written
informed consent document.
- Prior systemic chemotherapy for head and neck cancer is allowed only if performed as
part of a multimodal treatment for locally advanced disease and/or as first-line
treatment for recurrent/metastatic disease. The time to recurrence from the last
exposure of systemic chemotherapy must be more than 6 weeks. The first-line treatment
for recurrent/metastatic disease must not have contained a platinum agent.
- The participant has lymphoma involving the head or neck region.
- The participant has symptomatic brain or leptomeningeal metastasis.
- The participant has not recovered from Adverse Events due to agents administered more
than 4 weeks earlier. Neurotoxicity, if present, must have improved to Grade less
than 2 per the National Cancer Institute - Common Terminology Criteria for Adverse
Events (NCI-CTCAE) v 3.0.
- The participant is receiving any other investigational agent(s).
- The participant is receiving concurrent treatment with other anticancer therapy,
including chemotherapy, immunotherapy, hormonal therapy, RT, chemoembolization, or
targeted therapy. Participants receiving palliative radiation therapy to bony
metastases prior to the first dose of study medication are eligible.
- The participant is receiving therapy with immunosuppressive agents.
- The participant has known drug or alcohol abuse.
- The participant has uncontrolled hypertension defined as systolic blood pressure
greater than or equal to 180 millimeters of mercury (mm Hg) or diastolic blood
pressure greater than or equal to 130 mm Hg.
- The participant has a history of allergic reactions attributed to compounds of
chemical or biologic composition similar to those of cetuximab or cisplatin.
- The participant has a medical or psychological condition that would not permit the
participant to complete the study or sign informed consent.
- The participant has clinically relevant coronary artery disease or history of
myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia
or uncontrolled cardiac insufficiency.
- The participant, if female, is pregnant (confirmed by serum or urine beta-human
chorionic gonadotropin [β-HCG] pregnancy test) or breastfeeding
- The participant has had a known positive test result for the human immunodeficiency
- The participant has an active infection (requiring intravenous [IV] antibiotics),
- The participant has a history of another active primary invasive cancer within the
previous 2 years, excluding non-melanoma skin cancer.