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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01038661
First received: December 22, 2009
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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.

Condition Intervention Phase
Lung Neoplasms
Drug: Docetaxel
Drug: Cisplatin
Other: Best supportive care (BSC)
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Progression-free survival (PFS) during the maintenance treatment phase [ Time Frame: 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease control rate (DCR) during the first line treatment phase [ Time Frame: Every 2 cycles (6 weeks) ] [ Designated as safety issue: No ]
  • Overall response rate (ORR) during the first line treatment phase [ Time Frame: Every 2 cycles (6 weeks) ] [ Designated as safety issue: No ]
  • Time to disease progression (TTP) during the maintenance treatment phase [ Time Frame: From 2nd randomization up to disease progression (every 2 cycles (6 weeks)) ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: 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) ] [ Designated as safety issue: No ]

Enrollment: 375
Study Start Date: November 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: First line treatment: docetaxel 75 mg/m² + cisplatin 75 mg/m²
Docetaxel 75 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles
Drug: Docetaxel

Formulation: concentrated solution for intravenous infusion (IV)

Route(s) of administration: 1-hour IV

Other Name: Taxotere®
Drug: Cisplatin

Formulation: concentrated solution for intravenous infusion (IV)

Route(s) of administration: 1-3-hour IV

Experimental: First line treatment:: docetaxel 60 mg/m² + cisplatin 75 mg/m²
Docetaxel 60 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles
Drug: Docetaxel

Formulation: concentrated solution for intravenous infusion (IV)

Route(s) of administration: 1-hour IV

Other Name: Taxotere®
Drug: Cisplatin

Formulation: concentrated solution for intravenous infusion (IV)

Route(s) of administration: 1-3-hour IV

Experimental: Maintenance treatment: docetaxel (60 mg/m2)
Docetaxel 60 mg/m² on day 1, repeated every 3 weeks until progressive disease or up to 6 cycles
Drug: Docetaxel

Formulation: concentrated solution for intravenous infusion (IV)

Route(s) of administration: 1-hour IV

Other Name: Taxotere®
Active Comparator: Maintenance treatment: best supportive care (BSC)
BSC until progressive disease
Other: Best supportive care (BSC)
Any treatment including palliative radiotherapy for pain relief—but not chemotherapy — that is considered appropriate by the investigator

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038661

Locations
China
Sanofi-Aventis Administrative Office
Shanghai, China
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01038661     History of Changes
Other Study ID Numbers: DOCET_L_04827
Study First Received: December 22, 2009
Last Updated: February 27, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014