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Different Doses of Docetaxel (75 or 60 mg/m²) Plus Cisplatin as the First-line Chemotherapy Followed by Docetaxel (60mg/m²) as Maintenance Treatment in the Patients With Non-small Cell Lung Cancer (NSCLC): A Randomized, Controlled Study


Phase 4
18 Years
75 Years
Not Enrolling
Both
Lung Neoplasms

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Trial Information

Different Doses of Docetaxel (75 or 60 mg/m²) Plus Cisplatin as the First-line Chemotherapy Followed by Docetaxel (60mg/m²) as Maintenance Treatment in the Patients With Non-small Cell Lung Cancer (NSCLC): A Randomized, Controlled Study

Inclusion Criteria


Inclusion criteria:

- Histologic or cytologic diagnosis of advanced NSCLC

- Based on International Association for the Study of Lung Cancer (IASLC) 2009 new
Tumor-Node-Metastase (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

- 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 > 1UNL

- 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.

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:

Progression-free survival

Outcome Time Frame:

From randomization to any progression event or patient death for any cause (every 2 cycles during study treatment, and then every 8 weeks during follow-up period)

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

China: Food and Drug Administration

Study ID:

DOCET_L_04827

NCT ID:

NCT01038661

Start Date:

December 2009

Completion Date:

August 2012

Related Keywords:

  • Lung Neoplasms
  • Neoplasms
  • Lung Neoplasms

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