Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer

Phase 2

Completed

• Conditions: Lung Cancer

• Registration Number: NCT00005868
• Lead Sponsor: 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. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of docetaxel and cisplatin in treating patients who have untreated stage IIIA non-small cell lung cancer.

Detailed Description

OBJECTIVES:

* Assess the therapeutic activity of docetaxel and cisplatin in patients with untreated stage IIIA non-small cell lung cancer.

* Determine the safety of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour on day 1 and cisplatin IV over 30 minutes on days 1 and 2. Treatment continues every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 24-40 patients will be accrued for this study.

Study Timeline

• Study Start: 2000-03
• Study First Submitted: 2000-06-02
• Primary Completion: 2002-08
• Study First Submitted QC: 2003-05-20
• Study First Posted: 2003-05-21
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-17
• Last Update Posted: 2012-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (23)

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Istituto Nazionale per la Ricerca sul Cancro; 🇮🇹 Genoa (Genova), Italy

Groot Ziekengasthuis 's-Hertogenbosch; 🇳🇱 's-Hertogenbosch, Netherlands

Vrije Universiteit Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Zaas Medisch Centrum; 🇳🇱 Zaandam, Netherlands

Sophia Ziekehuis; 🇳🇱 Zwolle, Netherlands

Oncologia Medica - Perugia; 🇮🇹 Perugia, Italy

Sint Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Academisch Ziekenhuis Utrecht; 🇳🇱 Utrecht, Netherlands

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology; 🇵🇱 Warsaw, Poland

Canisius-Wilhelmina Ziekenhuis; 🇳🇱 Nijmegen, Netherlands

University Medical Center Nijmegen; 🇳🇱 Nijmegen, Netherlands

Twee Steden Ziekenhuis Vestiging Tilburg; 🇳🇱 Tilburg, Netherlands

Thoraxklinik Rohrbach; 🇩🇪 Heidelberg, Germany

University Hospital - Rotterdam Dijkzigt; 🇳🇱 Rotterdam, Netherlands

Royal Marsden Hospital; 🇬🇧 Sutton, England, United Kingdom

Weston Park Hospital; 🇬🇧 Sheffield, England, United Kingdom

Leyenburg Ziekenhuis; 🇳🇱 's-Gravenhage (Den Haag, The Hague), Netherlands

Antoni van Leeuwenhoekhuis; 🇳🇱 Amsterdam, Netherlands

Longarts Dr. J.M. Smit Rynstate Hospital; 🇳🇱 Arnhem, Netherlands

Ziekenhuis St Jansdal; 🇳🇱 Harderwijk, Netherlands

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Netherlands

Slotervaart Ziekenhuis; 🇳🇱 Amsterdam, Netherlands