Paclitaxel in Treating Patients With Lung Cancer

Phase 2

Completed

• Conditions: Lung Cancer

• Registration Number: NCT00002972
• 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.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have unresectable stage IIIB, stage IV or recurrent lung cancer.

Detailed Description

OBJECTIVES:

* Assess the therapeutic activity of paclitaxel in patients with bronchoalveolar carcinoma (BAC).

* Assess the duration of response in patients presenting with an objective response.

* Characterize the acute side effects of paclitaxel in patients with BAC.

* Assess the role of some biological parameters in the natural history and the response to therapy of BAC; evaluate the expression of Ki67, p53, and K-ras mutation.

OUTLINE: This is an open label, nonrandomized, multicenter study.

Paclitaxel is administered every 3 weeks as a 3 hour continuous infusion in dextrose or normal saline. Patients are treated for a minimum of 2 cycles unless serious toxicity or complication occur.

Disease is assessed every 6 weeks until documented progression; treatment side effects are assessed separately for each cycle of therapy. Treatment is given up to a maximum of 6 cycles of therapy or until disease progression, unacceptable toxicity, or patient refusal occurs.

PROJECTED ACCRUAL: 16 or 25 patients will be accrued.

Study Timeline

• Study Start: 1997-01
• Study First Submitted: 1999-11-01
• Primary Completion: 2002-08
• Study First Submitted QC: 2003-04-16
• Study First Posted: 2003-04-17
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-29
• Last Update Posted: 2012-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (5)

Azienda Ospedale S. Luigi - Universita Di Torino; 🇮🇹 Orbassano, (Torino), Italy

Universitaetsklinik und Strahlenklinik - Essen; 🇩🇪 Essen, Germany

Centre Hospitalier Regional de la Citadelle; 🇧🇪 Liege (Luik), Belgium

University Thomayers' Hospital; 🇨🇿 Krhanice, Czech Republic

Vrije Universiteit Medisch Centrum; 🇳🇱 Amsterdam, Netherlands