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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004151
Recruitment Status : Completed
First Posted : March 15, 2004
Last Update Posted : September 24, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: acridine carboxamide Phase 2

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Primary Purpose: Treatment
Official Title: Open Label Phase II Study on XR5000 Administered as a 5 Day Infusion in Advanced Non Small Cell Lung Cancer
Study Start Date : September 1999
Actual Primary Completion Date : November 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004151

Kaiser Franz Josef Hospital
Vienna, Austria, A-1100
Copenhagen, Denmark, 2100
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
Dijon, France, 21079
CHU de la Timone
Marseille, France, 13385
Haemato-Onkologische Praxis und Tagesklinik
Munich, Germany, D-80639
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, Italy, 80131
Istituti Fisioterapici Ospitalieri - Roma
Rome, Italy, 00161
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Axel R. Hanauske, MD, PhD, MBA Haemato-Onkologische Praxis und Tagesklinik

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00004151     History of Changes
Other Study ID Numbers: EORTC-16991N
First Posted: March 15, 2004    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
recurrent non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms