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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Bristol-Myers Squibb
Pierre Fabre Pharma GmbH
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00168883
First received: September 9, 2005
Last updated: October 31, 2006
Last verified: September 2006
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168883

Contacts
Contact: Ulrich Keilholz, MD +49-30-8445-3596 ulrich.keilholz@charite.de
Contact: Alexander Schmittel, MD +49-30-8445-3090 alexander.schmittel@charite.de

Locations
Germany
Hematology & Oncology Charité CBF Berlin Recruiting
Berlin, Germany, 12203
Contact: Ulrich Keilholz, MD    +49-30-8445-3596    ulrich.keilholz@charite.de   
Contact: Alexander Schmittel, MD    +49-30-8445-3090    alexander.schmittel@charite.de   
Principal Investigator: Ulrich Keilholz, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Bristol-Myers Squibb
Pierre Fabre Pharma GmbH
Investigators
Principal Investigator: Ulrich Keilholz, MD Charité Campus Benjamin Franklin
  More Information

No publications provided

ClinicalTrials.gov 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
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
NSCLC
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
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Vinorelbine
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014