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

Sanofi logo

Sanofi

Status and phase

Completed
Phase 3

Conditions

Lung Neoplasms

Treatments

Drug: Docetaxel
Drug: Cisplatin
Other: Best supportive care (BSC)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01038661
DOCET_L_04827

Details and patient eligibility

About

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.

Full 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.

Enrollment

375 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

375 participants in 4 patient groups

First line treatment: docetaxel 75 mg/m² + cisplatin 75 mg/m²
Experimental group
Description:
Docetaxel 75 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles
Treatment:
Drug: Cisplatin
Drug: Docetaxel
First line treatment:: docetaxel 60 mg/m² + cisplatin 75 mg/m²
Experimental group
Description:
Docetaxel 60 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles
Treatment:
Drug: Cisplatin
Drug: Docetaxel
Maintenance treatment: docetaxel (60 mg/m2)
Experimental group
Description:
Docetaxel 60 mg/m² on day 1, repeated every 3 weeks until progressive disease or up to 6 cycles
Treatment:
Drug: Docetaxel
Maintenance treatment: best supportive care (BSC)
Active Comparator group
Description:
BSC until progressive disease
Treatment:
Other: Best supportive care (BSC)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems