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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
Bristol-Myers Squibb
Pierre Fabre Pharma GmbH
Information provided by:
Charite University, Berlin, Germany Identifier:
First received: September 9, 2005
Last updated: October 31, 2006
Last verified: September 2006
This is a randomized study to assess the efficacy and safety of chemotherapy with platin compared to chemotherapy without platin.

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Carboplatin
Drug: Paclitaxel
Drug: Vinorelbine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Charite University, Berlin, Germany:

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

Estimated Enrollment: 80
Study Start Date: October 2002
Estimated Study Completion Date: December 2006
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).

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00168883

Contact: Ulrich Keilholz, MD +49-30-8445-3596
Contact: Alexander Schmittel, MD +49-30-8445-3090

Hematology & Oncology Charité CBF Berlin Recruiting
Berlin, Germany, 12203
Contact: Ulrich Keilholz, MD    +49-30-8445-3596   
Contact: Alexander Schmittel, MD    +49-30-8445-3090   
Principal Investigator: Ulrich Keilholz, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Bristol-Myers Squibb
Pierre Fabre Pharma GmbH
Principal Investigator: Ulrich Keilholz, MD Charite University, Berlin, Germany
  More Information Identifier: NCT00168883     History of Changes
Other Study ID Numbers: Haema CBF NSCLC UK/AS 03
Study First Received: September 9, 2005
Last Updated: October 31, 2006

Keywords provided by Charite University, Berlin, Germany:
curative non-treatable NSCLC UICC stage IIIB and IV

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017