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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


Phase 1
18 Years
79 Years
Not Enrolling
Both
Lip and Oral Cavity Cancer, Head and Neck Cancer, Oropharyngeal Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Marshall R. Posner

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000068117

NCT ID:

NCT00006106

Start Date:

July 1999

Completion Date:

Related Keywords:

  • Lip and Oral Cavity Cancer
  • Head and Neck Cancer
  • Oropharyngeal Cancer
  • 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
  • recurrent squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the nasopharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • solid tumor
  • stage III hypopharyngeal cancer
  • stage III laryngeal cancer
  • stage III lip and oral cavity cancer
  • stage III nasopharyngeal cancer
  • stage III oropharyngeal cancer
  • stage III paranasal sinus and nasal cavity cancer
  • stage III squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the nasopharynx
  • stage III squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV hypopharyngeal cancer
  • stage IV laryngeal cancer
  • stage IV lip and oral cavity cancer
  • stage IV nasopharyngeal cancer
  • stage IV oropharyngeal cancer
  • stage IV paranasal sinus and nasal cavity cancer
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage, hypopharyngeal cancer
  • stage, laryngeal cancer
  • stage, lip and oral cavity cancer
  • stage, metastatic squamous neck cancer with occult primary
  • stage, nasopharyngeal cancer
  • stage, oropharyngeal cancer
  • stage, paranasal sinus and nasal cavity cancer
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms
  • Mouth Neoplasms
  • Oropharyngeal Neoplasms
  • Lip Neoplasms

Name

Location

Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Dana-Farber Cancer InstituteBoston, Massachusetts  02115