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

NCT01038661 | Completed Phase 3

• 1 other identifier: DOCET_L_04827
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• Disease control rate (DCR) during the first line treatment phase

  Every 2 cycles (6 weeks)

• Overall response rate (ORR) during the first line treatment phase

  Every 2 cycles (6 weeks)

• Time to disease progression (TTP) during the maintenance treatment phase

  From 2nd randomization up to disease progression (every 2 cycles (6 weeks))

• 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)

Study Arms (4)

First line treatment: docetaxel 75 mg/m² + cisplatin 75 mg/m²

EXPERIMENTAL

Docetaxel 75 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles

Drug: Docetaxel; Drug: Cisplatin

First line treatment:: docetaxel 60 mg/m² + cisplatin 75 mg/m²

EXPERIMENTAL

Docetaxel 60 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles

Drug: Docetaxel; Drug: Cisplatin

Maintenance treatment: docetaxel (60 mg/m2)

EXPERIMENTAL

Docetaxel 60 mg/m² on day 1, repeated every 3 weeks until progressive disease or up to 6 cycles

Drug: Docetaxel

Maintenance treatment: best supportive care (BSC)

ACTIVE COMPARATOR

BSC until progressive disease

Other: Best supportive care (BSC)

Interventions

Docetaxel DRUG

Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-hour IV

Also known as: Taxotere®

First line treatment: docetaxel 75 mg/m² + cisplatin 75 mg/m²; First line treatment:: docetaxel 60 mg/m² + cisplatin 75 mg/m²; Maintenance treatment: docetaxel (60 mg/m2)

Cisplatin DRUG

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

First line treatment: docetaxel 75 mg/m² + cisplatin 75 mg/m²; First line treatment:: docetaxel 60 mg/m² + cisplatin 75 mg/m²

Best supportive care (BSC) OTHER

Any treatment including palliative radiotherapy for pain relief-but not chemotherapy - that is considered appropriate by the investigator

Maintenance treatment: best supportive care (BSC)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Shanghai, China

Location

Related Publications (1)

• Zhang L, Lu S, Cheng Y, Hu Z, Wu YL, Chen Z, Chen G, Liu X, Yang J, Zhang L, Chen J, Huang M, Tao M, Cheng G, Huang C, Zhou C, Zhang W, Zhao H, Sun Y. Docetaxel maintenance therapy versus best supportive care after first-line chemotherapy with different dose docetaxel plus cisplatin for advanced non-small cell lung cancer (TFINE study, CTONG-0904): an open-label, randomized, phase III trial. Ann Transl Med. 2021 Feb;9(4):338. doi: 10.21037/atm-20-8078.

  PMID: 33708965 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Docetaxel; Cisplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: December 24, 2009
• Study Start: November 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 28, 2014

Record last verified: 2014-02

Locations

CN (1)