Docetaxel in Non Small Cell Lung Cancer (NSCLC)

NCT00432315 | Completed Phase 2

• 1 other identifier: TAX_AT1_203
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (5)

• Resectability after induction therapy

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

• Time to progression

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

• Overall survival

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

• Safety profile

  throughout the study

• Quality of life

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

Study Arms (2)

1

EXPERIMENTAL

Resectable NSCLC

Drug: Docetaxel + CDDP

2

EXPERIMENTAL

Unresectable NSCSC

Drug: docetaxel + CDDP

Interventions

docetaxel + CDDP 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

1

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Vienna, Austria

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Alexandra Edlmayer, Dr.

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 6, 2007
• First Posted: February 7, 2007
• Study Start: May 1, 2001
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: September 14, 2010

Record last verified: 2010-09

Locations

AU (1)