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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

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


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).


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Ulrich Keilholz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charité Campus Benjamin Franklin

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

Haema CBF NSCLC UK/AS 03

NCT ID:

NCT00168883

Start Date:

October 2002

Completion Date:

December 2006

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • NSCLC
  • curative non-treatable NSCLC UICC stage IIIB and IV
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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