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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Cisplatin
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 23, 2014