RATIONALE: Drugs used in chemotherapy, such as SB-715992, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of SB-715992 in treating patients who have recurrent or metastatic head and neck cancer.

Condition	Treatment or Intervention	Phase
Hypopharyngeal Cancer Laryngeal Cancer lip and oral cavity cancer Oropharyngeal Cancer paranasal sinus and nasal cavity cancer Salivary Gland Cancer	Drug: SB-715992  Procedure: chemotherapy	Phase II

Further Study Details: 

OBJECTIVES: Primary

• Determine the antitumor activity of SB-715992, in terms of objective response rate (partial and complete response), in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

Secondary

• Determine the duration of objective response in patients treated with this drug.
• Determine the rate and duration of stable disease in patients treated with this drug.
• Determine the progression-free, median, and overall survival of patients treated with this drug.
• Determine the safety and tolerability of this drug in these patients.
• Determine the pharmacokinetics, including an assessment of significant covariates, of this drug in these patients.
• Correlate pharmacokinetics with safety and efficacy of this drug in these patients.

OUTLINE: This is an open-label, nonrandomized, multicenter study.

Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 19-33 patients will be accrued for this study within 9.5-16.5 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
• Recurrent or metastatic disease
• All primary tumor sites (except the nasopharynx) are eligible, including the following:
• Oral cavity
• Oropharynx
• Hypopharynx
• Larynx
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• Lesion must be outside of field of prior local therapy OR disease has progressed within the treatment field
• No known brain metastases

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 12 weeks

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• WBC ≥ 3,000/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 3.0 times ULN (5 times ULN if due to liver metastases)

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other

• No peripheral neuropathy > grade 1
• No history of allergic reaction attributed to compounds of similar chemical or biological composition to SB-715992
• No ongoing or active infection
• No other concurrent uncontrolled illness
• No psychiatric illness or social situation that would preclude study compliance
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy

• No concurrent anticancer biologic therapy
• No concurrent colony-stimulating factors during the first course of study therapy

Chemotherapy

• No more than 1 prior chemotherapy regimen for recurrent or metastatic disease
• Prior platinum-based chemotherapy given concurrently with radiotherapy or as induction therapy allowed
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy

• No concurrent anticancer hormonal therapy except for hormone replacement therapy

Radiotherapy

• See Chemotherapy
• At least 4 weeks since prior radiotherapy except low-dose, non-myelosuppressive radiotherapy and recovered
• No concurrent anticancer radiotherapy

Surgery

• At least 4 weeks since prior surgery

Other

• More than 6 months since prior and no concurrent amiodarone
• More than 4 weeks since prior investigational agents
• More than 2 weeks since prior and no concurrent use of any of the following CYP3A4 inhibitors or inducers:
• Clarithromycin
• Erythromycin
• Troleandomycin
• Itraconazole
• Ketoconazole
• Fluconazole (dose > 200 mg/day)
• Voriconazole
• Nefazodone
• Fluvoxamine
• Verapamil
• Diltiazem
• Grapefruit juice
• Phenytoin
• Carbamazepine
• Phenobarbital
• Rifampin
• Rifabutin
• Rifapentine
• Hypericum perforatum (St. John's wort)
• Modafinil
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent anticancer cytotoxic therapy
• No other concurrent anticancer therapy

Canada, Ontario
      Cancer Care Ontario-London Regional Cancer Centre, London,  Ontario,  N6A 4L6,  Canada; Recruiting
      Margaret and Charles Juravinski Cancer Centre, Hamilton,  Ontario,  L8V 5C2,  Canada; Recruiting
      Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus, Ottawa,  Ontario,  K1H 8L6,  Canada; Recruiting
      Princess Margaret Hospital, Toronto,  Ontario,  M5G 2M9,  Canada; Recruiting

Study chairs or principal investigators

Eric Winquist, MD,  Principal Investigator,  Cancer Care Ontario-London Regional Cancer Centre   

Study ID Numbers:  CDR0000394176; PMH-PHL-031; NCI-6803; NCT00095628
Record last reviewed:  November 2004
Last Updated:  April 4, 2005
Record first received:  November 5, 2004
ClinicalTrials.gov Identifier:  NCT00095628
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08