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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


Phase 2
19 Years
75 Years
Not Enrolling
Both
Carcinoma, Squamous Cell

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To assess the response rate to induction therapy with docetaxel in combination with CDDP

Outcome Time Frame:

every 3 months until tumour progression and thereafter every 6 months until death

Safety Issue:

No

Principal Investigator

Alexandra Edlmayer, Dr.

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Austria: Agency for Health and Food Safety

Study ID:

TAX_AT1_203

NCT ID:

NCT00432315

Start Date:

May 2001

Completion Date:

October 2009

Related Keywords:

  • Carcinoma, Squamous Cell
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell

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