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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Neoplasms

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Trial Information

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


Inclusion Criteria:



- 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
100,000/microliter (μL).

- 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.

Exclusion Criteria:

- 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
virus.

- The participant has an active infection (requiring intravenous [IV] antibiotics),
including tuberculosis.

- The participant has a history of another active primary invasive cancer within the
previous 2 years, excluding non-melanoma skin cancer.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Cisplatin pharmacokinetics: Area under the curve (AUC)

Outcome Time Frame:

Baseline (prior to Cisplatin infusion); 1, 1:30, 2, 3, 5, 8, 24, 72 hours (after the start of Cisplatin infusion) on Day 1 of weeks 1 and 5

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

13418

NCT ID:

NCT01099358

Start Date:

April 2010

Completion Date:

August 2016

Related Keywords:

  • Head and Neck Neoplasms
  • Cancer of Head
  • Cancer of Head and Neck
  • Cancer of Neck
  • Cancer of the Head
  • Cancer of the Head and Neck
  • Cancer of the Neck
  • Head and Neck Cancer
  • Head Cancer
  • Head Neoplasms
  • Head, Neck Neoplasms
  • Neck Cancer
  • Neck Neoplasms
  • Neoplasms
  • Head and Neck Neoplasms

Name

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Durham, North Carolina  
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Overland Park, Kansas  66210
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Las Vegas, Nevada  89169
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Marshfield, Wisconsin  54449