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 Completed adult NCI SWOG-9519 SWOG-9519

Objectives

I.  Estimate the response rate in patients with recurrent or metastatic 
squamous cell carcinoma of the head and neck treated with ICI D1694 (TDX) to 
assess whether TDX should be studied further.

II.  Describe the qualitative and quantitative toxic effects of TDX.

Entry Criteria

Disease Characteristics:

Histologically confirmed squamous cell carcinoma of the head and neck that is
metastatic or is refractory or recurrent following definitive surgery and/or
radiotherapy

Bidimensionally measurable disease by one of the following:
  Clearly defined margins by medical photograph (skin or oral lesion) with
     at least 1 diameter 0.5 cm or greater (excluding bone lesions)
  CT, MRI, or other imaging scan with both diameters greater than distance
     between cuts of imaging study
  Palpation with both diameters 2 cm or greater

Previously irradiated lesion must show clear progression if only evidence of
measurable disease

Prior/Concurrent Therapy:

Biologic therapy:
  No concurrent biologic therapy

Chemotherapy:
  At least 6 months since prior induction or adjuvant chemotherapy
     No more than 1 regimen allowed
  No prior chemotherapy for recurrent disease
  No concurrent chemotherapy

Endocrine therapy:
  No concurrent hormonal therapy (except oral contraceptives)

Radiotherapy:
  At least 4 weeks since radiotherapy and recovered
  No concurrent radiotherapy

Surgery:
  At least 4 weeks since surgery and recovered

Patient Characteristics:

Age:
  Adult

Performance status:
  SWOG 0-2

Hematopoietic:
  AGC at least 1,000
  Platelets at least 100,000

Hepatic:
  Bilirubin no greater than 1.5 times normal
  AST no greater than 2.5 times normal
  Alkaline phosphatase no greater than 2.5 times normal

Renal:
  Creatinine normal
  Creatinine clearance (24-hour or calculated) greater than 65 mL/min
  Calcium normal

Other:
  No concurrent vitamin supplements containing folic or folinic acid
  No prior malignancy within 5 years except:
     Adequately treated nonmelanomatous skin cancer
     In situ cervical cancer
  No pregnant or nursing women
  Effective contraception required of fertile patients

Blood/body fluid analyses within 28 days prior to registration
Imaging/exams for tumor measurement within 28 days prior to registration
Other screening exams within 42 days prior to registration

Expected Enrollment

40 patients will be entered at a rate of 3-4 patients/month.  If none of the 
first 20 patients responds, accrual will stop.

Outline

Single-Agent Chemotherapy.  ICI D1694, TDX, NSC-639186.

Samlowski WE, Lew D, Kuebler PJ, et al.: Evaluation of Tomudex in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: a Southwest Oncology Group study. Invest New Drugs 16 (3): 271-4, 1998-99.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Wolfram Samlowski, MD, BA, Protocol chair(Contact information may not be current)		Ph: 801-585-4477; 877-585-0303 Email: wolfram.samlowski@hci.utah.edu