Docetaxel in Non Small Cell Lung Cancer (NSCLC)

NCT ID: NCT00432315

Last Updated: 2010-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31
• Study Completion Date: 2009-10-31

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

Conditions

Carcinoma, Squamous Cell

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Resectable NSCLC

Group Type: EXPERIMENTAL

Docetaxel + CDDP

Intervention Type: DRUG

• 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

2

Unresectable NSCSC

Group Type: EXPERIMENTAL

docetaxel + CDDP

Intervention Type: DRUG

• 3 cycles chemotherapy: docetaxel + CDDP
• Radiochemotherapy
• 3 cycles adjuvant chemotherapy docetaxel

Interventions

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

Intervention Type: DRUG

docetaxel + CDDP

• 3 cycles chemotherapy: docetaxel + CDDP
• Radiochemotherapy
• 3 cycles adjuvant chemotherapy docetaxel

Intervention Type: DRUG

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Alexandra Edlmayer, Dr.

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Vienna, , Austria

Countries

Austria

Other Identifiers

TAX_AT1_203

Identifier Type: -

Identifier Source: org_study_id