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Clinical Trials/NCT00168883
NCT00168883
Unknown
Phase 2

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

Charite University, Berlin, Germany1 site in 1 country80 target enrollmentOctober 2002
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ConditionsCarcinoma, Non-Small-Cell Lung
DrugsCarboplatinPaclitaxelVinorelbine

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Carcinoma, Non-Small-Cell Lung
Sponsor
Charite University, Berlin, Germany
Enrollment
80
Locations
1
Primary Endpoint
Determination of response rate (stable disease [SD] or better)
Last Updated
19 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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).

Registry
clinicaltrials.gov
Start Date
October 2002
End Date
December 2006
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Outcomes

Primary Outcomes

Determination of response rate (stable disease [SD] or better)

Determination of safety of the combination and life quality

Secondary Outcomes

  • Determination of remission rate
  • Determination of time to progression
  • Determination of 1-year survival rate

Study Sites (1)

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