Tax First-line Chemotherapy With Different Doses and Then Maintenance Therapy (TFINE)
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01038661
First received: December 22, 2009
Last updated: December 18, 2012
Last verified: December 2012
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Purpose
The Primary Objective is to evaluate the progression-free survival. 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
- To evaluate the toxicity
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Neoplasms |
Drug: Docetaxel Drug: Cisplatin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Different Doses of Docetaxel (75 or 60 mg/m²) Plus Cisplatin as the First-line Chemotherapy Followed by Docetaxel (60mg/m²) as Maintenance Treatment in the Patients With Non-small Cell Lung Cancer (NSCLC): A Randomized, Controlled Study |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Progression-free survival [ Time Frame: From randomization to any progression event or patient death for any cause (every 2 cycles during study treatment, and then every 8 weeks during follow-up period) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Disease control rate [ Time Frame: Assessment during study treatment completed at every 2 cycles (6 weeks) ] [ Designated as safety issue: No ]
- Overall response rate [ Time Frame: Assessment during study treatment completed at every 2 cycles (6 weeks) ] [ Designated as safety issue: No ]
- Time to disease progression (TTP) [ Time Frame: From randomization to progressive disease is objectively documented (assessment during study treatment completed at every 2 cycles (6weeks) ) ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: From randomization to patient death for any cause (every 2 cycles (6weeks) during study treatment, and then every 8 weeks during follow-up period) ] [ Designated as safety issue: No ]
| Enrollment: | 382 |
| Study Start Date: | December 2009 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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. The Patients who demonstrated CR, PR, or SD within 1 month after the four cycles are then randomly assigned into two groups: one group received docetaxel (60 mg/m²) as maintenance on day 1, repeated every 3 weeks, until progressive disease, and another group received the best supportive care (BSC) |
Drug: Docetaxel
75 mg/m² or 60 mg/m²
Drug: Cisplatin
75 mg/m²
|
|
Experimental: 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. The Patients who demonstrated CR, PR, or SD within 1 month after the four cycles are then randomly assigned into two groups: one group received docetaxel (60 mg/m²) as maintenance on day 1, repeated every 3 weeks, until progressive disease, and another group received the best supportive care (BSC) |
Drug: Docetaxel
75 mg/m² or 60 mg/m²
Drug: Cisplatin
75 mg/m²
|
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 NSCLC
- Based on International Association for the Study of Lung Cancer (IASLC) 2009 new Tumor-Node-Metastase (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
- 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 > 1UNL
- 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 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: | December 18, 2012 |
| 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 May 19, 2013