Study in Advanced Solid Tumors



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2010
End Date:June 2016

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Phase 2 Study to Evaluate the Pharmacokinetics and Drug-Drug Interaction of Cetuximab and Cisplatin in Patients With Advanced Solid Tumors

The primary purpose of this study is to help answer the following research question(s):

- To see how the body absorbs, processes, and gets rid of cetuximab when the drug is
taken in combination with cisplatin [pharmacokinetic (PK) analysis]

- To see if any drug interactions occur between cetuximab and cisplatin.


Inclusion Criteria:

- The participant has histologically or cytologically advanced solid tumor that is
resistant to standard therapy or for which there is no standard therapy.

- The participant has measurable or non-measurable disease.

- 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/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.

- If the participant has received prior therapy with platinum, the time to the first
treatment of study drug from the last platinum exposure is >28 days.

Exclusion Criteria:

- 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.
We found this trial at
6
sites
Fayetteville, Arkansas 72703
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Fairway, Kansas 66205
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Fairway, KS
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London,
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Reno, NV
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