A Multicenter, Randomized Phase II Study Evaluating the Feasibility and Activity of Two Different Combinations of Docetaxel and Gemcitabine and of Cisplatin/Gemcitabine Followed by Docetaxel as First Line Therapy for Locally Advanced Unresectable or Metastatic Non-small Cell Lung Cancer.

Sanofi1 site in 1 country165 target enrollmentJuly 2002

ConditionsNon-small Cell Lung Cancer

InterventionsDocetaxel and Gemcitabine Gemcitabine cisplatin followed by docetaxel

DrugsDocetaxel and Gemcitabine Gemcitabine cisplatin followed by docetaxel

Overview

Phase: Phase 2
Intervention: Docetaxel and Gemcitabine
Conditions: Non-small Cell Lung Cancer
Sponsor: Sanofi
Enrollment: 165
Locations: 1
Primary Endpoint: Response Rate
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To assess the antitumour activity (response rate) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) of two different combinations of docetaxel and gemcitabine and of a sequential treatment of cisplatin /gemcitabine followed by docetaxel as first line chemotherapy · To evaluate the quantitative and qualitative toxicity of each treatment arms.· To determine time to progression, duration of response, time to treatment failure, and overall survival in each group.· To evaluate changes from baseline in the Lung Cancer Symptom Scale of patients in each treatment arm.

Registry

clinicaltrials.gov

Start Date

July 2002

End Date

April 2005

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically confirmed diagnosis of NSCLC istologic subtypes may include large cell, squamous cell, or adenocarcinoma or a generic cytological diagnosis of NSCLC;
•Patients must have a locoregionally advanced unresectable non metastatic NSCLC Stage IIIB (only N3 supraclavicular or T4 for pleural effusion) or Stage IV according to the revised International Staging System
•Patients must have at least one measurable lesion;
•Previous radical surgery (more 30 days before study entry) is allowed but a pathologic proof of progression of neoplastic disease must be documented whenever possible;
•Weight loss \< = 5% within the last 3 months;
•Laboratory requirements at entry :
•Blood cell counts: Absolute neutrophils \> 2.0 x 109/LPlatelets \> 100 x 109/LHemoglobin \> 10 g/dl
•Renal function:Serum creatinine \< 1 upper normal limits (UNL). In case of limit value of serum creatinine, the creatinine clearance should be \> 60 mL/min
•Hepatic functions:Serum bilirubin \< 1 x UNLASAT and ALAT \< 2.5 x UNLAlkaline phosphatase \< 5 x UNL (unless accompanied by extensive bone metastases);
•Exclusion criteria: