Docetaxel in Non Small Cell Lung Cancer (NSCLC)

Sanofi

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Squamous Cell

Treatments: Drug: docetaxel + CDDP; Drug: Docetaxel + CDDP

Study type: Interventional

Funder types: Industry

Identifiers

NCT00432315

TAX_AT1_203

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

1

Experimental group

Description:

Resectable NSCLC

Treatment:

Drug: Docetaxel + CDDP

2

Experimental group

Description:

Unresectable NSCSC

Treatment:

Drug: docetaxel + CDDP