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

Lung Cancer Clinical Trial

Official title:

Open Label Phase II Study on XR5000 Administered as a 5 Day Infusion in Advanced Non Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004151
• Other study ID #: EORTC-16991N
• Secondary ID: EORTC-16991N
• Status: Completed
• Phase: Phase 2
• First received: December 10, 1999
• Last updated: September 20, 2012
• Start date: September 1999

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. primary completion date: November 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• acridine carboxamide

Locations

Country	Name	City	State
Austria	Kaiser Franz Josef Hospital	Vienna
Denmark	Rigshospitalet	Copenhagen
France	Centre de Lute Contre le Cancer,Georges-Francois Leclerc	Dijon
France	CHU de la Timone	Marseille
Germany	Haemato-Onkologische Praxis und Tagesklinik	Munich
Italy	Istituto Nazionale per lo Studio e la Cura dei Tumori	Naples
Italy	Istituti Fisioterapici Ospitalieri - Roma	Rome
Spain	Hospital Universitario 12 de Octubre	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Austria,  Denmark,  France,  Germany,  Italy,  Spain,