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Trial record 31 of 2004 for:    Oral Cancer | NIH

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

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ClinicalTrials.gov Identifier: NCT00006106
Recruitment Status : Withdrawn
First Posted : April 29, 2004
Last Update Posted : July 10, 2013
Dana-Farber Cancer Institute
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Lip and Oral Cavity Cancer Head and Neck Cancer Oropharyngeal Cancer Drug: cisplatin Drug: fluorouracil Drug: ONYX-015 Phase 1

Detailed Description:


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.


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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Primary Purpose: 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
Study Start Date : July 1999

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006106

United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Study Chair: Marshall R. Posner Dana-Farber Cancer Institute

ClinicalTrials.gov Identifier: NCT00006106     History of Changes
Other Study ID Numbers: DFCI-98320
CDR0000068117 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: April 29, 2004    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: December 2006

Keywords provided by National Cancer Institute (NCI):
adult solid tumor
body system/site 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
laryngeal cancer
lip and oral cavity cancer
lip and oral cavity squamous cell carcinoma
metastatic squamous neck cancer with occult primary
nasopharyngeal cancer
oropharyngeal cancer
paranasal sinus and nasal cavity cancer
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
recurrent squamous cell carcinoma of the lip and oral cavity
solid tumor
stage III hypopharyngeal cancer
stage III laryngeal cancer
stage III lip and oral cavity cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Oropharyngeal Neoplasms
Mouth Neoplasms
Lip Neoplasms
Neoplasms by Site
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Mouth Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Lip Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs