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

Alternate Title

Acridine Carboxamide in Treating Patients With Advanced Non-small Cell Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over EORTC-16991N NCT00004151

Objectives

I. Determine the effect of acridine carboxamide on objective response, 
response rate, and duration of response in patients with unresectable, locally 
advanced, progressive or metastatic non-small cell lung cancer.  

II. Determine the toxicities and pharmacokinetics of this regimen in these 
patients.

Entry Criteria

Disease Characteristics:

Histologically proven unresectable, locally advanced, progressive or
metastatic non-small cell lung cancer 
 Not amenable to curative surgery or radiotherapy 
 No prior first line chemotherapy for metastatic or advanced disease

At least 1 bidimensionally measurable target lesion by CT scan

No symptomatic brain metastases

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 See Disease Characteristics
 No prior chemotherapy
 
Endocrine therapy:
 Not specified

Radiotherapy:
 At least 4 weeks since prior radiotherapy

Surgery:
 At least 2 weeks since prior major surgery

Other:
 No other concurrent anticancer agents
 No other concurrent investigational therapy

Patient Characteristics:

Age:
 18 and over

Performance status:
 ECOG 0-2

Life expectancy:
 At least 3 months

Hematopoietic:
 WBC greater than 3,000/mm3
 Platelet count greater than 100,000/mm3

Hepatic:
 Bilirubin less than 1.5 times upper limit of normal (ULN)
 SGOT, SGPT, and alkaline phosphatase no greater than 2 times ULN (5 times ULN
  if liver metastases present)
 
Renal:
 Creatinine no greater than 1.7 mg/dL

Cardiovascular:
 No ischemic heart disease within the past 6 months
 Normal 12 lead ECG

Other:
 Not pregnant or nursing
 Negative pregnancy test
 Fertile patients must use effective contraception
 No other prior or concurrent malignancy except cone biopsied carcinoma of the
  cervix or adequately treated basal or squamous cell skin cancer
 No unstable systemic disease or active uncontrolled infection
 No psychological, familial, sociological, or geographical condition that
  could preclude compliance 

Expected Enrollment

A total of 14-25 patients will be accrued for this study.

Outline

This is a multicenter study.

Patients receive acridine carboxamide IV over 24 hours for 5 days.  Treatment 
repeats every 3 weeks for a maximum of 6 courses in the absence of disease 
progression or unacceptable toxicity.   

Patients are followed every 6 weeks until disease progression or commencement 
of another treatment.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Axel Hanauske, MD, PhD, MBA, Protocol chair(Contact information may not be current)		Ph: 49-89-557-272

Registry Information
Official Title		Open Label Phase II Study on XR5000 Administered as a 5 Day Infusion in Advanced Non Small Cell Lung Cancer
Trial Start Date		1999-09-09
Registered in ClinicalTrials.gov		NCT00004151
Date Submitted to PDQ		1999-10-12
Information Last Verified		2001-12-01