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

NCT01587820 | Terminated Early Phase 1 DMC

• 1 other identifier: ROB-SCI 12-001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Head and Neck Cancer

Keywords

cisplatin; RADPLAT; intra-arterial chemotherapy; head and neck cancer

Outcome Measures

Primary Outcomes (1)

• number of enrolled subjects

  enrollment

  2 years

Secondary Outcomes (2)

• patient survival

  2 years

• rate of patient morbidity

  2 years

Study Arms (2)

Intra-arterial cisplatin and radiation

EXPERIMENTAL

150 mg/m2 cisplatin given intra-arterially combined with sodium thiosulfate infusion given on days 1, 8, 15, for a total of 4 cycles, each cycle totaling 7 days and Radiotherapy: Primary tumor and upper neck will be treated with 2 Gy/fraction, once a day, five days a week to a total dose of 70 Gy/35 fractions/7 weeks

Drug: Intra-arterial cisplatin

Intravenous cisplatin and radiation

ACTIVE COMPARATOR

100 mg/m2 cisplatin given intravenously once every 21 days (3 week cycle) for 3 cycles and Radiotherapy: Primary tumor and upper neck will be treated with 2 Gy/fraction, once a day, five days a week to a total dose of 70 Gy/35 fractions/7 weeks

Drug: Intravenous cisplatin

Interventions

Intra-arterial cisplatin DRUG

150 mg/m2 cisplatin given intra-arterially combined with sodium thiosulfate infusion given on days 1, 8, 15, for a total of 4 cycles, each cycle totaling 7 days and Radiotherapy: Primary tumor and upper neck will be treated with 2 Gy/fraction, once a day, five days a week to a total dose of 70 Gy/35 fractions/7 weeks

Intra-arterial cisplatin and radiation

Intravenous cisplatin DRUG

100 mg/m2 cisplatin given intravenously once every 21 days (3 week cycle) for 3 cycles and Radiotherapy: Primary tumor and upper neck will be treated with 2 Gy/fraction, once a day, five days a week to a total dose of 70 Gy/35 fractions/7 weeks

Intravenous cisplatin and radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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)

Sponsors & Collaborators

• Southern Illinois University: lead

Study Sites (2)

Southern Illinois University School of Medicine

Springfield, Illinois, 62701, United States

Location

Simmons Cancer Institute at SIU School of Medicine

Springfield, Illinois, 62702, United States

Location

Related Publications (5)

• Samant S, van den Brekel MW, Kies MS, Wan J, Robbins KT, Rosenthal DI, Rasch C, Weber RS. Concurrent chemoradiation for adenoid cystic carcinoma of the head and neck. Head Neck. 2012 Sep;34(9):1263-8. doi: 10.1002/hed.21905. Epub 2011 Nov 15.

  PMID: 22083968 BACKGROUND

• Robbins KT, Howell SB, Williams JS. Intra-arterial chemotherapy for head and neck cancer: is there a verdict? Cancer. 2010 May 1;116(9):2068-70. doi: 10.1002/cncr.24930. No abstract available.

  PMID: 20186833 BACKGROUND

• Robbins KT, Homma A. Intra-arterial chemotherapy for head and neck cancer: experiences from three continents. Surg Oncol Clin N Am. 2008 Oct;17(4):919-33, xi. doi: 10.1016/j.soc.2008.04.015.

  PMID: 18722926 BACKGROUND

• Doweck I, Robbins KT, Samant S, Vieira F. Intra-arterial chemoradiation for T3-4 oral cavity cancer: treatment outcomes in comparison to oropharyngeal and hypopharyngeal carcinoma. World J Surg Oncol. 2008 Jan 14;6:2. doi: 10.1186/1477-7819-6-2.

  PMID: 18194553 BACKGROUND

• Rabbani A, Hinerman RW, Schmalfuss IM, Amdur RJ, Morris CG, Peters KR, Robbins KT, Mendenhall WM. Radiotherapy and concomitant intraarterial cisplatin (RADPLAT) for advanced squamous cell carcinomas of the head and neck. Am J Clin Oncol. 2007 Jun;30(3):283-6. doi: 10.1097/01.coc.0000258118.38177.74.

  PMID: 17551306 BACKGROUND

Related Links

• Simmons Cancer Institute at SIU School of Medicine

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• K. Thomas Robbins, MD

  Southern Illinois University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2012
• First Posted: April 30, 2012
• Study Start: June 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 5, 2014

Record last verified: 2014-07

Locations

US (2)