NCT00005091

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 DX-8951f in treating patients who have previously untreated stage IIIB or stage IV non-small cell lung cancer.

Trial Health

93
On Track

Trial Health Score

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

Timeline
Completed

Started Feb 1999

Typical duration for phase_2 lung-cancer

Geographic Reach
5 countries

6 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

February 1, 1999

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2000

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
10 months until next milestone

First Posted

Study publicly available on registry

June 8, 2004

Completed
Last Updated

July 10, 2013

Status Verified

January 1, 2008

First QC Date

April 6, 2000

Last Update Submit

July 9, 2013

Conditions

Lung Cancer

Keywords

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

Interventions

exatecan mesylateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed unresectable, metastatic, or recurrent non-small cell lung cancer Stage IIIB or IV Measurable disease No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No active congestive heart failure Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent serious infection No other malignancy within past 5 years except nonmelanomatous skin cancer No overt psychosis, mental disability, or incompetence No life threatening illness PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to greater than 25% of the bone marrow No concurrent radiotherapy Surgery: No concurrent surgery Other: At least 28 days since prior investigational drugs No other concurrent investigational drugs during or within 28 days after final dose of study drug No concurrent drugs that induce or inhibit CYP3A enzyme

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

Sponsors & Collaborators

Study Sites (6)

Helsinki University Central Hospital

Helsinki, FIN-0-0029, Finland

Location

Thoraxklinik Rohrbach

Heidelberg, D-69126, Germany

Location

Ospedale Bellaria

Bologna, I-40139, Italy

Location

Academisch Ziekenhuis der Vrije Universiteit

Amsterdam, 1117 MB, Netherlands

Location

Christie Hospital N.H.S. Trust

Manchester, England, M20 4BX, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 7LJ, United Kingdom

Location

Related Publications (1)

  • Braybrooke JP, Ranson M, Manegold C, Mattson K, Thatcher N, Cheverton P, Sekiguchi M, Suzuki M, Oyama R, Talbot DC. Phase II study of exatecan mesylate (DX-8951f) as first line therapy for advanced non-small cell lung cancer. Lung Cancer. 2003 Aug;41(2):215-9. doi: 10.1016/s0169-5002(03)00190-9.

    PMID: 12871785RESULT

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

exatecan

Condition Hierarchy (Ancestors)

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

Study Officials

  • Nick Thatcher, PhD, FRCP

    The Christie NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 6, 2000

First Posted

June 8, 2004

Study Start

February 1, 1999

Study Completion

August 1, 2003

Last Updated

July 10, 2013

Record last verified: 2008-01

Locations

IT(1)GB(2)FI(1)DE(1)NL(1)