Clinical Trials Logo

Clinical Trial Summary

The optimal strategy in advanced non small cell lung cancer with stable disease is not well known. There is no published study assessing an early change of chemotherapeutic drugs in these patients.Accordingly, we conduct this trial with the objective to improve the rate of objective responses by the switch to another doublet after 2 cycles of CDDP-gemcitabine association for patients with stable diseases (SD).


Clinical Trial Description

Patients with stage IV NSCLC and measurable disease are included in a randomized phase II trial comparing for patients with stable disease after 2 cycles of a platin (P)-gemcitabine doublet (P d1: 75 mg/m2, gemcitabine 1 250 mg/m2 d1, d8 every three weeks) two subsequent cycles of this doublet (arm A) to a switch to another doublet (arm B) : paclitaxel 100 mg/m2 d1, d8, d15, gemcitabine 1 250 mg/m2 d1, d8, every four weeks.Platin, gemcitabine and paclitaxel are administered according nadir and pre-cycle haematologic evaluations (with dose decrease if needed). Response criteria are assessed with RECIST classification by the investigator panel. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT00199758
Study type Interventional
Source University Hospital, Limoges
Contact
Status Completed
Phase Phase 2
Start date September 2003
Completion date June 2007

See also
  Status Clinical Trial Phase
Active, not recruiting NCT01229150 - Randomized Phase II Study of AZD6244 (Mitogen-activated Protein Kinase Inhibitor) MEK-Inhibitor With Erlotinib in KRAS Wild Type Advanced Non-Small Cell Lung Cancer (NSCLC) and a Randomized Phase II Study of AZD6244 With Erlotinib in Mutant KRAS Adva... Phase 2
Terminated NCT00592007 - Study Evaluating the Addition of Fulvestrant to Erlotinib in Stage IIIB/IV Non-Small Cell Lung Cancer Phase 2
Completed NCT01999738 - Folic Acid-Tubulysin Conjugate EC1456 In Patients With Advanced Solid Tumors Phase 1
Completed NCT01941316 - Study of Carfilzomib With Irinotecan in Irinotecan-Sensitive Malignancies and Small Cell Lung Cancer Patients Phase 1/Phase 2
Completed NCT00111839 - Effects of Matuzumab in Combination With Pemetrexed for the Treatment of Advanced Lung Cancer Phase 2
Completed NCT00181532 - Phase II Study of Celecoxib and Concurrent Radiotherapy in Stage II-III NSCLC Phase 2
Completed NCT00864266 - Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer N/A
Completed NCT00890903 - Non-Interventional Study With Vinorelbine ORAL in Advanced Non-Small Cell Lung Carcinoma(NSCLC) and Metastatic Breast Cancer (MBC) N/A
Completed NCT00635791 - Phase I Study of Vorinostat and Sorafenib in Advanced Cancer Phase 1
Recruiting NCT00727350 - Protocol for Primary Fractionated Stereotactic Body Radiation Therapy for Stage T1 - T3N0 Non Small Cell Lung Carcinoma. Phase 2
Completed NCT01209520 - Residual Hypermethylation in Early Stage Non-Small Cell Lung Cancer (NSCLC) As Part of Adjuvant Therapy and Preventive Strategy N/A
Active, not recruiting NCT00759382 - Prognostic Role of Primary Non Small Cell Lung Carcinoma Standardized F18-FDG Uptake Values (SUV and TLG) Measured With F18-fluorodeoxyglucose Positron Emission Tomography (F18-FDG-PET): a Non Interventional Study.
Completed NCT00087711 - A Randomized Phase 3 Trial of Pemetrexed and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer Phase 3
Completed NCT00252798 - ZD1839 (Iressaâ„¢) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer Phase 1
Completed NCT02938624 - Anti PD-1 Neo-adjuvant Treatment for NSCLC Phase 1
Terminated NCT00661011 - Lobectomy and Mediastinal Radiochemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer Responding to Induction Chemotherapy Phase 2
Completed NCT00608868 - SELINE: Second-Line Iressa Phase IV Study in NSCLC Patients Phase 4
Terminated NCT00234468 - Iressa vs Placebo as Maintenance Therapy in Locally Advanced NSCLC Phase 3
Completed NCT00193921 - Chemoradiotherapy in Patients With Localised Lung Cancer Phase 2
Completed NCT00252746 - ZD6474 Phase IIa Dose Finding Multicentre Study Phase 2