Study for Patients With Non Small Cell Lung Cancer (NSCLC)
Conditions
Carcinoma, Non-Small-Cell Lung
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords
NSCLC, curative non-treatable NSCLC UICC stage IIIB and IV
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Carboplatin Type: Drug
Name: Paclitaxel Type: Drug
Name: Vinorelbine Type: Drug
Overall Status
Recruiting
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
Hematology & Oncology Charité CBF Berlin
Berlin, Germany
Status: Recruiting
Contact: Ulrich Keilholz, MD - +49-30-8445-3596 - ulrich.keilholz@charite.de
Start Date
October 2002
Completion Date
December 2006
Sponsors
Charite University, Berlin, Germany
Source
Charite University, Berlin, Germany
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page