Study for Patients With Non Small Cell Lung Cancer (NSCLC)

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

Randomized Phase II Study to Determine the Efficacy of a Three Weekly vs. Weekly Therapy With Paclitaxel Plus Carboplatin vs. Paclitaxel Plus Vinorelbine for Patients With Non Small Cell Lung Cancer According to UICC Stage IIIB and IV

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00168883
• Other study ID #: Haema CBF NSCLC UK/AS 03
• Status: Recruiting
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: October 31, 2006
• Start date: October 2002
• Est. completion date: December 2006

Study information

• Verified date: September 2006
• Source: Charite University, Berlin, Germany
• Contact: Ulrich Keilholz, MD
• Phone: +49-30-8445-3596
• Email: ulrich.keilholz[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This is a randomized study to assess the efficacy and safety of chemotherapy with platin compared to chemotherapy without platin.

Description:

Randomized Phase II design, multicenter study, to assess the efficacy and safety of combined chemotherapy with Paclitaxel and Carboplatin versus a platinum free chemotherapy with Paclitaxel and Vinorelbine, within the combination therapies there are two different dosing intervals, which will be assessed as well (4 Arm study).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chemotherapy naive patients with histologically confirmed NSCLC stage III and IV

Exclusion Criteria:

• New York Heart Association (NYHA) III or IV

• Brain metastases

• Neurotoxicity Grade 2 or greater

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Carboplatin

• Paclitaxel

• Vinorelbine

Locations

Country	Name	City	State
Germany	Hematology & Oncology Charité CBF Berlin	Berlin

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Bristol-Myers Squibb, Pierre Fabre Pharma GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of response rate (stable disease [SD] or better)
Primary	Determination of safety of the combination and life quality
Secondary	Determination of remission rate
Secondary	Determination of time to progression
Secondary	Determination of 1-year survival rate