Clinical trial NCT00432315: Docetaxel in Non Small Cell Lung Cancer (NSCLC)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Squamous Cell
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-02-07
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: To assess the response rate to induction therapy with docetaxel in combination with CDDP
timeFrame: every 3 months until tumour progression and thereafter every 6 months until death
Secondary outcomes:
measure: Resectability after induction therapy
timeFrame: every 3 months until tumour progression and thereafter every 6 months until death
measure: Time to progression
timeFrame: every 3 months until tumour progression and thereafter every 6 months until death
measure: Overall survival
timeFrame: every 3 months until tumour progression and thereafter every 6 months until death
measure: Safety profile
timeFrame: throughout the study
measure: Quality of life
timeFrame: every 3 months until tumour progression and thereafter every 6 months until death
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Alexandra Edlmayer, Dr.
role: STUDY_DIRECTOR
References: