Docetaxel in Non Small Cell Lung Cancer (NSCLC)

Carcinoma, Squamous Cell Clinical Trial

Official title:

Multicenter Phase II Study Evaluating Docetaxel and CDDP as Induction Regimen Prior to Surgery or Radiochemotherapy With Docetaxel, Followed by Adjuvant Docetaxel Therapy in Chemonaive Patients With NSCLC Stage II, IIIa and IIIb

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00432315
• Other study ID #: TAX_AT1_203
• Status: Completed
• Phase: Phase 2
• First received: February 6, 2007
• Last updated: September 13, 2010
• Start date: May 2001
• Est. completion date: October 2009

Study information

• Verified date: September 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

Primary objective:

• To assess the response rate to induction therapy with docetaxel/CDDP.

Secondary objectives:

To assess

• Resectability after induction therapy

• Time to progression

• Overall survival

• Safety profile

• Quality of Life

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Histology and staging of the disease

• Histologically or cytologically confirmed NSCLC; histology may include: large cell, squamous cell or adenocarcinoma but no SCLC

• Resectable or unresectable NSCLC stage II (T1-2 N1, T3 N0) or stage IIIa (T1-2 N2 or T3 N1-2) or stage IIIb (T1-3 N3 or T4 N0-3)

• Measurable disease (bidimensionally or unidimensionally according to WHO criteria)

2. General conditions

• Karnofsky Status > 70, if age > 70 years ? PS > 70

• Adequate hematological function (Hb > 10 g/dl, ANC > 2.0 x 109/L, platelets > 100 x 109/L)

• Adequate renal and hepatic functions: total bilirubin < 1 x upper normal limit (UNL), serum creatinine < 1 x UNL, in case of limit value the creatinine clearance should be > 60 ml/min, ASAT and ALAT < 2.5 x UNL, alkaline phosphatase < 5 x UNL.

Exclusion Criteria:

1. Diagnosis

• Evidence of brain metastases or other distant metastasis equivalent to stage IV disease

• History of prior malignancies, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix or other curatively treated cancer with no evidence of disease for at least five years

• Other serious concomitant illness or medical condition:

• Congestive heart failure or angina pectoris, except if medically controlled, history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmia

• History of significant neurologic or psychiatric disorders, including dementia or seizure

• Active infection requiring i.v. Antibiotics

• Active ulcer, unstable diabetes mellitus or other contraindications to corticotherapy

• Hepatic function abnormality: ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL

• Current peripheral neuropathy WHO grade > 2

2. Prior or concurrent therapy

• Prior chemotherapy or immunotherapy for NSCLC, including neoadjuvant or adjuvant treatment

• Prior surgery or radiotherapy for NSCLC

• Concurrent treatment with other experimental drugs, unapproved medical procedures or other anticancer therapy

3. General conditions

• Pregnant or lactating patients

• Patients (M/F) with reproductive potential not implementing adequate contraceptive measurements

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell

Intervention

Drug:
• Docetaxel + CDDP
3 cycles chemotherapy : docetaxel + CDDP Surgery (if no histologically proven R0-resection could be achieved,additional adjuvant radiotherapy should be considered) 3 cycles adjuvant chemotherapy docetaxel
• docetaxel + CDDP
3 cycles chemotherapy: docetaxel + CDDP Radiochemotherapy 3 cycles adjuvant chemotherapy docetaxel

Locations

Country	Name	City	State
Austria	Sanofi-Aventis Administrative Office	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the response rate to induction therapy with docetaxel in combination with CDDP		every 3 months until tumour progression and thereafter every 6 months until death	No
Secondary	Resectability after induction therapy		every 3 months until tumour progression and thereafter every 6 months until death	No
Secondary	Time to progression		every 3 months until tumour progression and thereafter every 6 months until death	No
Secondary	Overall survival		every 3 months until tumour progression and thereafter every 6 months until death	No
Secondary	Safety profile		throughout the study	No
Secondary	Quality of life		every 3 months until tumour progression and thereafter every 6 months until death	No