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Docetaxel in Non Small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00432315
First received: February 6, 2007
Last updated: September 13, 2010
Last verified: September 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ]

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

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00432315

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

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00432315     History of Changes
Other Study ID Numbers: TAX_AT1_203
Study First Received: February 6, 2007
Last Updated: September 13, 2010
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Squamous Cell
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013