NCT00004151

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2 lung-cancer

Geographic Reach
6 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2000

Completed
3.4 years until next milestone

First Posted

Study publicly available on registry

March 15, 2004

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

1.2 years

First QC Date

December 10, 1999

Last Update Submit

September 20, 2012

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancer

Interventions

acridine carboxamideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (8)

Kaiser Franz Josef Hospital

Vienna, A-1100, Austria

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Centre de Lute Contre le Cancer,Georges-Francois Leclerc

Dijon, 21079, France

Location

CHU de la Timone

Marseille, 13385, France

Location

Haemato-Onkologische Praxis und Tagesklinik

Munich, D-80639, Germany

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Naples, 80131, Italy

Location

Istituti Fisioterapici Ospitalieri - Roma

Rome, 00161, Italy

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

DACA, acridine

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Axel R. Hanauske, MD, PhD, MBA

    Haemato-Onkologische Praxis und Tagesklinik

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 1999

First Posted

March 15, 2004

Study Start

September 1, 1999

Primary Completion

November 1, 2000

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

DK(1)IT(2)FR(2)ES(1)DE(1)AU(1)