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

• Status: Terminated
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southern Illinois University
• Treatments: Cisplatin; Sodium thiosulfate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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