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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	UCCRC-8014 NCI-T95-0083H, T95-0083

Objectives

I.  Determine the objective response rate to aminocamptothecin (9-AC) given as 
palliative treatment for patients with advanced squamous cell carcinoma of the 
head and neck.

II.  Describe the toxicity of 9-AC.

III.  Determine the duration of response, time to progression, and survival in 
these patients.

IV.  Characterize further the pharmacokinetics and pharmacodynamics of 9-AC.

Entry Criteria

Disease Characteristics:

Histologically or cytologically confirmed squamous cell carcinoma of the head
and neck
  Metastatic or recurrent OR
  Locally advanced and judged incurable by surgery or radiotherapy

Bidimensionally measurable indicator lesion
  At least 1 x 1 cm
  Clearly defined margins on chest x-ray, CT, or physical exam
  No previously irradiated lesion
     New lesion in radiotherapy field allowed if at least 3 months since
     completion of radiotherapy

Prior/Concurrent Therapy:

No prior therapy for metastatic or recurrent disease

Biologic therapy:
  At least 3 weeks since biologic therapy and recovered

Chemotherapy:
  At least 3 weeks since chemotherapy and recovered
  No more than 1 prior adjuvant/neoadjuvant chemotherapy regimen
     No evidence of progressive or recurrent disease during treatment

Endocrine therapy:
  No prior hormonal therapy

Radiotherapy:
  At least 3 weeks since radiotherapy and recovered

Surgery:
  At least 3 weeks since surgery and recovered

Patient Characteristics:

Age:
  18 and over

Performance status:
  CALGB 0-2

Hematopoietic:
  ANC at least 1,500
  Platelets at least 100,000
  Hemoglobin at least 10 g/dL
  Hematocrit at least 30%

Hepatic:
  Bilirubin no greater than 1.5 mg/dL
  Hepatic enzymes no greater than 3 times normal

Renal:
  Creatinine no greater than 1.5 mg/dL

Other:
  No serious concomitant systemic disorder incompatible with study
  No active infection
  No second primary malignancy within 2 years of diagnosis
  No pregnant or nursing women
  Adequate contraception required of fertile patients

Expected Enrollment

A total of 40 patients will be enrolled over 2 years if there is at least 1 
response in the first 14 patients.

Outline

Single-Agent Chemotherapy.  Aminocamptothecin, 9-AC, NSC-603071.

Trial Contact Information

Trial Lead Organizations

University of Chicago Cancer Research Center

Thomas Lad, MD, Protocol chair(Contact information may not be current)		Ph: 773-702-9200; 888-824-0200