Tax First-line Chemotherapy With Different Doses and Then Maintenance Therapy

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The Primary Objective is to evaluate the progression-free survival (PFS).

The secondary objectives are:

• To compare the disease control rates of different doses of Docetaxel+Cisplatin as first-line treatment according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria;

• To evaluate the overall response rate (ORR);

• To evaluate the time to disease progression (TTP);

• To evaluate the overall survival (OS);

• To evaluate the toxicity.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Cisplatin; Docetaxel

Criteria

Inclusion criteria:

• Histologic or cytologic diagnosis of advanced non-small-cell lung cancer (NSCLC)

• Based on International Association for the Study of Lung Cancer (IASLC) 2009 new Tumor-Node-Metastasis (TNM) stage criteria of lung cancer, local advanced stage IIIB (not applicable for radical radiation therapy) disease or metastatic stage IV disease or recurrent disease

• At least one evaluable tumor lesion based on RECIST criteria (>= 20 mm with conventional techniques or >= 10 mm with spiral Computed Tomography scan)

• Eastern Cooperative Oncology Group performance status (ECOG PS) 0/1

• Adequate bone marrow reserve

• absolute neutrophil count >= 2.0×10^9/L

• platelets >= 100×10^9/L

• hemoglobin >= 9.0 g/dL

• Adequate hepatic function

• total bilirubin <= Upper Normal Limit (UNL)

• Aspartate Amino Transferase (AST), Alanine Amino Transferase (ALT) <= 2.5 UNL

• alkaline phosphatase (ALP) <= 5 UNL

• Adequate renal function (serum creatinine <= UNL or creatinine clearance >= 60 mL/min)

• No prior chemotherapy was allowed or only (neo) adjuvant chemotherapy ended more than 6 months before treatment (patients should not have been heavily pre-treated, the maximum cumulative dose of cisplatin allowed is 350 mg/m²)

• Prior surgery was permitted only if the operation performed more than 4 weeks ago and the patient was completely recovery

• Childbearing potential either terminated or attenuated by the use of an approved contraceptive method

• Inform consent signed

Exclusion criteria:

• Other tumour type than advanced / metastatic NSCLC in recent 5 years (except cone-biopsied carcinoma-in-situ of the cervix or adequately treated basal or squamous cell carcinoma of the skin).

• Presence of symptomatic central nervous system metastases

• Inadequate liver function

• total bilirubin > 1 UNL

• ALT and/or AST>1.5 UNL associated with alkaline phosphatase > 2.5 UNL

• inadequate renal function (creatinine > 1.0 times UNL and in case of limit value, creatinine clearance < 60 mL/min)

• Prior radiation therapy, or surgery operation within 4 weeks

• Prior use of taxoids

• Active infection, or serious concomitant systemic disorder incompatible with the study

• Childbearing potential but unwilling to use of an approved contraceptive method

• Receive treatment from other clinical trials during this study treatment

• History of hypersensitivity to any of study medication

• Other serious concomitant abnormal or illness

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.