ONYX-015 With Cisplatin and Fluorouracil in Treating Patients With Advanced Head and Neck Cancer - Full Text View

Sponsor:	National Cancer Institute (NCI)
Collaborator:	Dana-Farber Cancer Institute
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006106

Purpose

RATIONALE: A specially modified virus called ONYX-015 may be able to kill tumor cells while leaving normal cells undamaged. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining ONYX-015 with chemotherapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of ONYX-015 combined with cisplatin and fluorouracil in treating patients who have advanced head and neck cancer.

Condition	Intervention	Phase
Lip and Oral Cavity Cancer Head and Neck Cancer Oropharyngeal Cancer	Drug: cisplatin Drug: fluorouracil Drug: ONYX-015	Phase I

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase I Study of Intraarterial ONYX-015 in Combination With Intravenous Cisplatin and Fluorouracil in Patients With Advanced Squamous Cell Cancer of the Head and Neck

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Fluorouracil Cisplatin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

July 1999

Detailed Description:

OBJECTIVES:

I. Determine the feasibility and maximum tolerated dose (MTD) of intraarterial ONYX-015 in patients with advanced squamous cell cancer of the head and neck.

II. Determine the feasibility and tolerability of intraarterial ONYX-015 at the MTD OR maximum theraputic dose, whichever is lower, in combination with intravenous cisplatin and fluorouracil in these patients.

III. Determine the qualitative distribution of ONYX-015 within a limited tumor biopsy and a normal mucosal biopsy at different dose levels.

IV. Determine the response of these patients to intraarterial ONYX-015. V. Determine the response of these patients to cisplatin and fluorouracil following intraarterial ONYX-015.

PROTOCOL OUTLINE: This is a dose escalation study. Patients receive intraarterial infusions of ONYX-015. Treatment repeats once in 3-4 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-8 patients receive escalating doses of ONYX-015 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 patients experience dose limiting toxicity.

Patients in cohorts 1-4 are followed for 5 days after infusion, weekly for 3 weeks, at week 6, and monthly thereafter for 4 months.

A fifth or final cohort of 10 patients will receive ONYX-015 at the MTD. If the MTD was not determined in cohorts 1-4, patients receive the highest dose administered to cohort 4. Beginning 1-2 days after ONYX-015 infusion, patients receive cisplatin IV over 30-60 minutes once and fluorouracil IV continuously over 4 days. Treatment repeats in 4 weeks in the absence of disease progression or unacceptable toxicity. Cisplatin and fluorouracil IV treatment continues every 3-4 weeks at the discretion of the treating oncologist.

Patients in cohort 5 are followed for 5 days after initial infusion, weekly for 4 weeks, at week 8, and monthly thereafter for 4 months.

PROJECTED ACCRUAL:

A total of 23-28 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) that is incurable by standard therapy
Measurable or evaluable disease
Multiple SCCHN primaries allowed
Metastases allowed if tumor to be treated is confined to head and neck region

--Prior/Concurrent Therapy--

Biologic therapy: Recovered from prior biologic therapy
Chemotherapy: At least 3 weeks since prior chemotherapy and recovered
Endocrine therapy: Recovered from prior endocrine therapy
Radiotherapy: At least 12 weeks since prior radiotherapy and recovered
Surgery: Recovered from prior surgery
Other: Recovered from any prior diagnostic or theraputic procedures

--Patient Characteristics--

Age: 18 to physiologic 79
Performance status: ECOG 0-2
Life expectancy: Over 3 months
Hematopoietic: WBC greater than 3,000/mm3 OR Absolute neutrophil count greater than 2,000/mm3; Platelet count greater than 100,000/mm3; Hemoglobin greater than 10 g/dL (transfusions allowed if not used solely to meet eligibility criteria)
Hepatic: SGOT less than 2.5 times upper limit of normal (ULN); Alkaline phosphatase less than 3 times ULN; Bilirubin no greater than 1.5 times ULN
Renal: Creatinine less than 1.6 mg/dL OR Creatinine clearance greater than 50 mL/min
Cardiovascular: No active cardiovascular disease that would limit physical activity (i.e., ability to walk 50 feet without stopping)
Pulmonary: No active pulmonary disease that would limit physical activity (i.e., ability to walk 50 feet without stopping)
Other: No other prior or concurrent malignancy within the past 3 years except limited basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix; Adequate and nutritionally balanced enteral intake of at least 1,800 kcal/day (enteral feeding tube dependent allowed); No intravenous alimentation as primary source of calories; No other serious illness or medical condition that would preclude study (i.e., active systemic lupus erythematosus, Crohn's disease or AIDS); No prior immunodeficiency (i.e., HIV infection, organ transplant, or chronic steroid use); Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006106

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

National Cancer Institute (NCI)

Dana-Farber Cancer Institute

Investigators

Study Chair:

Marshall R. Posner

Dana-Farber Cancer Institute

More Information

No publications provided

Study ID Numbers:	CDR0000068117, DFCI-98320, NCI-G00-1832
Study First Received:	August 3, 2000
Last Updated:	January 11, 2007
ClinicalTrials.gov Identifier:	NCT00006106 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult solid tumor
body system/site cancer
cancer
cellular diagnosis, hypopharyngeal cancer
cellular diagnosis, laryngeal cancer
cellular diagnosis, lip and oral cavity cancer
cellular diagnosis, nasopharyngeal cancer
cellular diagnosis, oropharyngeal cancer
cellular diagnosis, paranasal sinus and nasal cavity cancer
head and neck cancer
hypopharyngeal cancer
hypopharyngeal squamous cell carcinoma
laryngeal cancer
laryngeal squamous cell carcinoma
lip and oral cavity cancer

lip and oral cavity squamous cell carcinoma
metastatic squamous neck cancer with occult primary
nasopharyngeal cancer
nasopharyngeal squamous cell carcinoma
oropharyngeal cancer
oropharyngeal squamous cell carcinoma
paranasal sinus and nasal cavity cancer
paranasal sinus and nasal cavity squamous cell carcinoma
recurrent hypopharyngeal cancer
recurrent laryngeal cancer
recurrent lip and oral cavity cancer
recurrent metastatic squamous neck cancer with occult primary
recurrent nasopharyngeal cancer
recurrent oropharyngeal cancer
recurrent paranasal sinus and nasal cavity cancer

Additional relevant MeSH terms:

Mouth Diseases
Antimetabolites
Otorhinolaryngologic Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Pharyngeal Neoplasms
Mouth Neoplasms
Neoplasms by Site
Cisplatin
Therapeutic Uses

Otorhinolaryngologic Diseases
ONYX015
Pharyngeal Diseases
Lip Diseases
Lip Neoplasms
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Head and Neck Neoplasms
Fluorouracil
Stomatognathic Diseases
Oropharyngeal Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009