Intra-arterial Versus Intravenous Cisplatin, Combined With Radiation, for Oral Cavity and Oropharynx Cancer

Stopped early · Early Phase 1

Conditions studied: Head and Neck Cancer

In brief

This is a randomized, open-label investigator initiated pilot/ feasibility study comparing the effectiveness of intra-arterial administration of cisplatin therapy to intravenous administration of cisplatin when each is combined with the radiation therapy found in standard care. Participants will be randomized to either intra-arterial or intravenous cisplatin chemotherapy. This study is designed to determine whether a large scale study is practical in the investigators clinical setting. Approximately 10 subjects will be enrolled over a 2 year period.

Key facts

Study ID

NCT01587820

Run by

Southern Illinois University

People needed

1

Starts

2012-06-01

Expected to finish

2014-08-01

Last updated by the study team

2014-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to understand and the willingness to sign a written informed consent document
• Histologically or cytologically confirmed stage IV squamous cell carcinoma of the oral cavity or oropharynx staged according to AJCC guidelines
• T4 staged tumor with a tumor volume greater than or equal to 30 cc
• Nodal staging of N0 through 2a
• No evidence of distant metastatic disease, as determined by a negative PET scan or other clinically appropriate means
• Age ≥ 18
• Clinically eligible for both intra-arterial and intravenous administration of cisplatin
• Women of childbearing potential must have a negative pregnancy test.
• Agree to use adequate contraception prior to study entry and for the duration of study participation and for 3 months after study treatment ended
• Biopsiable via a transoral approach
• Life expectancy of at least 5 years
• ECOG performance status ≤ 2
• Measurable disease as defined by RECIST criteria
• Absolute neutrophil count ≥ 1,000/mm3
• Hemoglobin ≥ 8.0 g/dl
• Platelet count ≥ 100,000/mm3
• Leukocytes≥3500/mcL
• Total Bilirubin ≤ ULN of institution performing testing
• Creatinine within normal institutional limits

You may not qualify if…

• Radiologic evidence of bone destruction
• Tumor with involvement of cartilage or bone
• Requires bilateral IA infusion with radiologist determination that tumor extends across the midline in excess of 30% of the tumor volume
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents and pre-medications used in the study, including drugs formulated with polysorbate 80
• Allergy to cardiac catheterization contrast agents, in which antihistamines are not sufficient to suppress a reaction or severe enough to pose a significant danger to the subject
• History of stroke, CABG, or significant blockage of carotid arteries or coronary arteries or current blockage of coronary or carotid arteries equal to or in excess of 50% blockage; Interventional radiology must agree that the patient is a good candidate for catheterization.
• Intolerance to IV, IA, or radiation therapy treatment for any reason as determined by the procedural physician
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnancy
• Breast feeding women
• Prior or concurrent non-head and neck malignancies, excluding adequately treated basal or squamous cell cancer of the skin, in situ cervical cancer, stage I or II cancer from which the subject has been in complete remission for at least 12 months, any cancer from which the subject has been cancer free for 5 years
• Tumor site which cannot provide a biopsy in the clinic via punch or core needle biopsy performed
• Second primary head and neck tumor (concurrent or previous head and neck tumor unless it was a basal or squamous cell skin cancer)
• Unknown primary tumor site
• Prior surgery, chemotherapy, biologic or radiotherapy for a head or neck malignancy (excluding minor surgical procedures for skin cancer)
• History of surgery (non-oncologic) in the field of the tumor or treatment bed.
• Participation in an investigational treatment or intervention study within 90 days of screening visit
• calculated creatinine clearance less than 60 mL/min/1.73 m2

Where it is running

• Southern Illinois University School of Medicine — Springfield, Illinois, United States
• Simmons Cancer Institute at SIU School of Medicine — Springfield, Illinois, United States

Full record on ClinicalTrials.gov

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