RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of acridine carboxamide in treating patients who have advanced non-small cell lung cancer that cannot be treated with surgery.

Condition	Treatment or Intervention	Phase
stage IIIA non-small cell lung cancer stage IV non-small cell lung cancer stage IIIB non-small cell lung cancer recurrent non-small cell lung cancer	Drug: acridine carboxamide	Phase II

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.

PROTOCOL 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.

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

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL 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

Austria
      Kaiser Franz Josef Hospital, Vienna,  A-1100,  Austria
Denmark
      Rigshospitalet, Copenhagen,  2100,  Denmark
France
      Centre de Lute Contre le Cancer,Georges-Francois Leclerc, Dijon,  21079,  France
      CHU de la Timone, Marseille,  13385,  France
Germany
      Haemato-Onkologische Praxis und Tagesklinik, Munich,  D-80639,  Germany
Italy
      Istituti Fisioterapici Ospitalieri - Roma, Rome,  00161,  Italy
      Istituto Nazionale per lo Studio e la Cura dei Tumori, Naples,  80131,  Italy
Spain
      Hospital Universitario 12 de Octubre, Madrid,  28041,  Spain

Study chairs or principal investigators

Axel R. Hanauske,  Study Chair,  EORTC Lung Cancer Cooperative Group   

Study ID Numbers:  CDR0000067384; EORTC-16991N
Record last reviewed:  March 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004151
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-25