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Docetaxel in Non Small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00432315
First Posted: February 7, 2007
Last Update Posted: September 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  Purpose

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

Condition Intervention Phase
Carcinoma, Squamous Cell Drug: Docetaxel + CDDP Drug: docetaxel + CDDP Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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 ]

Secondary Outcome Measures:
  • Resectability after induction therapy [ Time Frame: every 3 months until tumour progression and thereafter every 6 months until death ]
  • Time to progression [ Time Frame: every 3 months until tumour progression and thereafter every 6 months until death ]
  • Overall survival [ Time Frame: every 3 months until tumour progression and thereafter every 6 months until death ]
  • Safety profile [ Time Frame: throughout the study ]
  • Quality of life [ Time Frame: every 3 months until tumour progression and thereafter every 6 months until death ]

Enrollment: 80
Study Start Date: May 2001
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Resectable NSCLC
Drug: 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
Experimental: 2
Unresectable NSCSC
Drug: docetaxel + CDDP
  • 3 cycles chemotherapy: docetaxel + CDDP
  • Radiochemotherapy
  • 3 cycles adjuvant chemotherapy docetaxel

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00432315


Locations
Austria
Sanofi-Aventis Administrative Office
Vienna, Austria
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Alexandra Edlmayer, Dr. Sanofi
  More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00432315     History of Changes
Other Study ID Numbers: TAX_AT1_203
First Submitted: February 6, 2007
First Posted: February 7, 2007
Last Update Posted: September 14, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Docetaxel
Cisplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action