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

Alternate Title

Aminocamptothecin in Treating Patients With Advanced Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	over 18	NCI	JHOC-T94-0133 NCI-T94-0133D, T94-0133

Objectives

I.  Assess the objective response rate to aminocamptothecin (9-AC) 
administered as a 72-hour continuous infusion q 2 weeks as first-line 
chemotherapy in patients with advanced nonsmall cell lung cancer.

II.  Describe the toxicities of 9-AC.

III.  Investigate the clinical pharmacology of 9-AC and assess the 
relationship of pertinent pharmacologic parameters to toxicity and antitumor 
response.

Entry Criteria

Disease Characteristics:

Histologically or cytologically confirmed, locally advanced or metastatic
nonsmall cell lung cancer not amenable to surgical resection or definitive
radiotherapy

Bidimensionally measurable lesion required
  At least 1 x 1 cm
  Previously unirradiated

Stable CNS metastases eligible provided:
  Radiotherapy completed previously
  No symptomatic or radiographic disease progression

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  At least 3 weeks since radiotherapy and recovered
  
Surgery:
  Prior surgery allowed if recovered

Patient Characteristics:

Age:
  Over 18

Performance status:
  ECOG 0-2

Life expectancy:
  At least 3 months

Hematopoietic:
  ANC at least 1,500
  Platelets at least 100,000

Hepatic:
  Bilirubin no greater than 1.5 mg/dl
  SGPT and SGOT less than 5 x normal

Renal:
  Creatinine no greater than 1.5 mg/dl

Other:
  No active infection
  No history of hemorrhagic cystitis
  No other medical problems that would limit compliance or treatment
  No second malignancy within the past 5 years, except:
     Nonmelanomatous skin cancer
     In situ carcinoma of the cervix
  No pregnant women
  Effective contraception required of fertile patients

Expected Enrollment

If at least 1 response is seen in the first 12 evaluable patients, 25 
additional patients will be accrued.  Accrual will require approximately 13 to 
19 months.

Outline

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

Trial Contact Information

Trial Lead Organizations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

David Ettinger, MD, Protocol chair		Ph: 410-955-8847 Email: ettinda@jhmi.edu