Docetaxel in Non Small Cell Lung Cancer (NSCLC) - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 6, 2007

Last Updated Date

March 6, 2009

Start Date ^†

May 2001

Current Primary Outcome Measures ^†

To assess the response rate to induction therapy with docetaxel in combination with CDDP [ Time Frame: every 3 months until tumour progression and thereafter every 6 months until death ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

To assess the response rate (ORR) after induction therapy with docetaxel in combination with CDDP in patients with NSCLC stage II, IIIa and IIIb
ORR will be determined by the percentage of patients achieving objective response rates (CR + PR) according to the WHO guidelines.

Change History

Complete list of historical versions of study NCT00432315 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Resectability after induction therapy [ Time Frame: every 3 months until tumour progression and thereafter every 6 months until death ] [ Designated as safety issue: No ]
Time to progression [ Time Frame: every 3 months until tumour progression and thereafter every 6 months until death ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: every 3 months until tumour progression and thereafter every 6 months until death ] [ Designated as safety issue: No ]
Safety profile [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: every 3 months until tumour progression and thereafter every 6 months until death ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

To evaluate resectability after induction therapy, which will be determined by lung function according to national guidelines(Arbeitskreis Bronchuskarzinom
Funktionelle Operationskriterien,1998)and for patients who were primary unresectable by mediastinoscopy
To assess time to progression (TTP) for all patients, who received at least 2 cycles of induction chemotherapy
TTP is defined as time elapsed from the date of patient inclusion until recorded date of progression(local failure, distant metastasis)
To assess overall survival (OS) (median survival time and percentage of 1-year survival)
To characterize and quantitate toxic effects of the scheduled therapy
Safety profile and tolerability will be assessed by recording adverse events,clinically significant laboratory abnormalities,physical examination and vital signs
Toxicities will be evaluated according to the WHO Toxicity Criteria and adverse events which are not reported in WHO will be graded as mild, moderate,severe or life-threatening
All patients who received any of the scheduled therapy will be included in the overall toxicity analysis
To evaluate the effect of the scheduled therapy on quality of life (QoL)
QoL will be assessed by questionnaire.

Descriptive Information

Brief Title ^†

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

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

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Carcinoma, Squamous Cell

Intervention ^†

Drug: Docetaxel + CDDP
Drug: docetaxel + CDDP

Study Arms / Comparison Groups

Experimental: Resectable NSCLC
Experimental: Unresectable NSCSC

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Completion Date

Estimated Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

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)
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:

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
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
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.

Gender

Both

Ages

19 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Austria

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00432315

Responsible Party

Medical Affairs Study Director, sanofi-aventis

Secondary IDs ^††

Study Sponsor ^†

Sanofi-Aventis

Collaborators ^††

Investigators ^†

Study Director:

Alexandra Edlmayer, Dr.

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.