Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI SWOG-8932 SWOG-8932

Objectives

I.  Determine the response rate to piroxantrone in patients with recurrent and 
metastatic squamous cell carcinoma of the head and neck.
II.  Evaluate the toxicities of piroxantrone in this patient population.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients at least 18 years of age 
with histologically proven squamous cell carcinoma of the head and neck (other 
than skin cancer) that has persisted or recurred following surgery and/or 
radiotherapy and is not curable by other forms of therapy.  Also eligible are 
those with newly diagnosed metastatic disease, but patients with newly 
diagnosed nonmetastatic disease and patients with brain metastasis are 
excluded.  Patients who have received induction or adjuvant chemotherapy only 
are eligible, provided at least 6 months have elapsed since the last course of 
chemotherapy.  Patients may not have received a cumulative dose of more than 
250 mg/sqm of doxorubicin or 50 mg/sqm of mitoxantrone; those who have 
received prior doxorubicin or mitoxantrone must have an LVEF of at least 45% 
by MUGA scan.  At least 4 weeks must have elapsed since prior radiotherapy.  
Patients must have objectively measurable disease on x-ray, CT scan, or 
physical examination (palpable neck nodes with both diameters at least 2 cm or 
photographable oral lesions with at least one dimension greater than 0.5 cm).  
Patients whose only measurable disease is within a previous radiation port 
must demonstrate clearly progressive disease.  A WBC of at least 4,000 and a 
normal platelet count are required and the serum bilirubin and creatinine must 
be within institutional normal limits.  Patients with myocardial infarction 
within the previous 6 months, a history of CHF, angina, or serious arrhythmias 
requiring treatment are not eligible. There must not have been a previous 
malignancy except for adequately treated basal cell or squamous cell skin 
cancer, in situ cervical cancer, and other cancer from which the patient has 
been disease-free for at least 5 years.  Pregnant and lactating women are 
excluded, and men and women of reproductive potential must practice effective 
contraception.  Bloodwork and other body fluid analysis required for 
eligibility determination and imaging studies and physical examination for 
tumor measurement must be completed within 14 days prior to registration; 
screening exams other than blood/body fluid analysis and imaging studies of 
nonmeasurable disease or uninvolved organs must be completed within 42 days 
prior to registration.

Expected Enrollment

If at least one response is observed in the first 15 patients, an additional 
15 patients will be entered.  The anticipated accrual rate is 8-9 
patients/month.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  Piroxantrone, NSC-349174.

Taylor SA, Benedetti J, Schuller D, et al.: Phase II trial of piroxantrone in patients with recurrent and metastatic squamous cell carcinoma of the head and neck. A Southwest Oncology Group trial. Invest New Drugs 11 (2-3): 227-9, 1993 May-Aug.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Sarah Taylor, MD, Protocol chair(Contact information may not be current)		Ph: 816-861-4700 ext. 491