Back to resultsStudy for Patients With Non Small Cell Lung Cancer (NSCLC)
Primary Purpose
Carcinoma, Non-Small-Cell Lung
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Carboplatin
Paclitaxel
Vinorelbine
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring NSCLC, curative non-treatable NSCLC UICC stage IIIB and IV
Eligibility Criteria
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
Sites / Locations
- Hematology & Oncology Charité CBF BerlinRecruiting
Outcomes
Primary Outcome Measures
Determination of response rate (stable disease [SD] or better)
Determination of safety of the combination and life quality
Secondary Outcome Measures
Determination of remission rate
Determination of time to progression
Determination of 1-year survival rate
Full Information
NCT ID
NCT00168883
First Posted
September 9, 2005
Last Updated
October 31, 2006
Sponsor
Charite University, Berlin, Germany
Collaborators
Bristol-Myers Squibb, Pierre Fabre Pharma GmbH
1. Study Identification
Unique Protocol Identification Number
NCT00168883
Brief Title
Study for Patients With Non Small Cell Lung Cancer (NSCLC)
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Bristol-Myers Squibb, Pierre Fabre Pharma GmbH
4. Oversight
5. Study Description
Brief Summary
This is a randomized study to assess the efficacy and safety of chemotherapy with platin compared to chemotherapy without platin.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
NSCLC, curative non-treatable NSCLC UICC stage IIIB and IV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Primary Outcome Measure Information:
Title
Determination of response rate (stable disease [SD] or better)
Title
Determination of safety of the combination and life quality
Secondary Outcome Measure Information:
Title
Determination of remission rate
Title
Determination of time to progression
Title
Determination of 1-year survival rate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ulrich Keilholz, MD
Phone
+49-30-8445-3596
Email
ulrich.keilholz@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Schmittel, MD
Phone
+49-30-8445-3090
Email
alexander.schmittel@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Keilholz, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hematology & Oncology Charité CBF Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrich Keilholz, MD
Phone
+49-30-8445-3596
Email
ulrich.keilholz@charite.de
First Name & Middle Initial & Last Name & Degree
Alexander Schmittel, MD
Phone
+49-30-8445-3090
Email
alexander.schmittel@charite.de
First Name & Middle Initial & Last Name & Degree
Ulrich Keilholz, MD
12. IPD Sharing Statement
Learn more about this trial
Study for Patients With Non Small Cell Lung Cancer (NSCLC)
We'll reach out to this number within 24 hrs