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-7485 NCI-T94-0144H, T94-0144

Objectives

I.  Estimate the objective response rate of aminocamptothecin (9-AC) as 
palliative treatment in patients with nonsmall cell lung cancer with no prior 
chemotherapy.

II.  Describe the toxicities associated with this treatment.

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

IV.  Examine the pharmacokinetics and pharmacodynamics of 9-AC.
  

Entry Criteria

Disease Characteristics:

Histologically or cytologically diagnosed nonsmall cell lung cancer that is
unresectable, i.e.:
  Stage IIIB:  Any T, supraclavicular nodes (N3) or cytologically positive
     pleural effusion, M0
  Stage IV:  Any T, any N, M1

Bidimensionally measurable disease outside any prior radiotherapy field
required
  At least 1 x 1 cm by physical exam, chest x-ray, or CT

  Brain metastases not considered measurable

No untreated CNS metastases

Prior/Concurrent Therapy:

No prior chemotherapy
At least 3 weeks since other treatment and recovered

Patient Characteristics:

Age:
  18 and over

Performance status:
  CALGB 0-2

Hematopoietic:
  ANC at least 1,500
  Platelets at least 100,000
  Hb at least 10 g/dl
  Hct at least 30%

Hepatic:
  Bilirubin no greater than 1.5 mg/dl
  Liver enzymes no greater than 3 x normal

Renal:
  Creatinine no greater than 1.5 mg/dl

Other:
  No serious concomitant systemic disorders incompatible with study
  No active infection
  No second malignancy within 3 years except:
     Cervical carcinoma in situ
     Adequately treated basal cell skin cancer
  No pregnant or nursing women
  Effective contraception (IUD, birth control pills, or barrier device)
     required of fertile women

Blood/body fluid analyses to determine eligibility completed within 48 hours
prior to registration; all other baseline studies completed within 14 days
prior to registration

Expected Enrollment

Up to 40 patients will be enrolled over 2 years.  If no responses are seen in 
the first 14 patients, accrual will cease.

Outline

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

Trial Contact Information

Trial Lead Organizations

University of Chicago Cancer Research Center

Rafat Ansari, MD, FACP, Protocol chair		Ph: 574-234-5123