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

Lung Neoplasms Clinical Trial

— TFINE  

Official title:

Randomized, Controlled Study Comparing the Efficacy and Safety of Docetaxel （60mg/m2）Maintenance Treatment vs. Best Supportive Care Following First Line Chemotherapy With Different Doses of Docetaxel（75/60mg/m2）in Combination With Cisplatin in Patients With Local Advanced or Metastatic （Stage IIIB/IV）Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01038661
• Other study ID #: DOCET_L_04827
• Status: Completed
• Phase: Phase 3
• First received: December 22, 2009
• Last updated: February 27, 2014
• Start date: November 2009
• Est. completion date: August 2012

Study information

• Verified date: February 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

The study consists in:

• A first line treatment phase: participants receive 4 cycles of chemotherapy (each cycle contains 3 weeks) with either docetaxel (75 mg/m2) plus cisplatin (75 mg/m2) or docetaxel (60 mg/m2) plus cisplatin (75 mg/m2) ,

• A maintenance treatment phase: participants with disease control (complete response [CR], partial response [PR] or stable disease [SD]) after the initial treatment receive up to 6 cycles of chemotherapy with docetaxel (60 mg/m2) or best supportive care (BSC).

• A follow-up period from the end of study treatment until participant death or end of study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

Drug:
• Docetaxel
Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-hour IV
• Cisplatin
Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-3-hour IV

Other:
• Best supportive care (BSC)
Any treatment including palliative radiotherapy for pain relief—but not chemotherapy — that is considered appropriate by the investigator

Locations

Country	Name	City	State
China	Sanofi-Aventis Administrative Office	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS) during the maintenance treatment phase		From 2nd randomization to progression or death of any cause (every 2 cycles (6 weeks) during study treatment, and then every 8 weeks during follow-up period)	No
Secondary	Disease control rate (DCR) during the first line treatment phase		Every 2 cycles (6 weeks)	No
Secondary	Overall response rate (ORR) during the first line treatment phase		Every 2 cycles (6 weeks)	No
Secondary	Time to disease progression (TTP) during the maintenance treatment phase		From 2nd randomization up to disease progression (every 2 cycles (6 weeks))	No
Secondary	Overall survival (OS)		From 1st randomization to death of any cause (every 2 cycles (6 weeks) during study treatment, and then every 8 weeks during follow-up period)	No