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

September 20, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Axel R. Hanauske, MD, PhD, MBA, Haemato-Onkologische Praxis und Tagesklinik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1999

Primary Completion (Actual)

November 1, 2000

Study Registration Dates

First Submitted

December 10, 1999

First Submitted That Met QC Criteria

March 12, 2004

First Posted (Estimate)

March 15, 2004

Study Record Updates

Last Update Posted (Estimate)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-16991N

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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