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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Lung Neoplasms

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

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)

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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)