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Safety Study of Docetaxel/Cisplatin Induction Therapy Followed by Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy Followed by Consolidation Docetaxel/Cisplatin in NSCLC Patients

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.
 
ClinicalTrials.gov Identifier: NCT00271323
Recruitment Status : Terminated
First Posted : December 30, 2005
Last Update Posted : December 23, 2009
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE December 29, 2005
First Posted Date  ICMJE December 30, 2005
Last Update Posted Date December 23, 2009
Study Start Date  ICMJE May 2005
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2008)
  • overall response rate [ Time Frame: in population of patients eligible and evaluable for response ]
  • time to progression [ Time Frame: from the date of start treatment until progression ]
  • duration of response [ Time Frame: only on responders ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Docetaxel/Cisplatin Induction Therapy Followed by Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy Followed by Consolidation Docetaxel/Cisplatin in NSCLC Patients
Official Title  ICMJE A Two Arm Phase II Study Assessing Docetaxel/Cisplatin Induction Therapy Followed by Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy Followed by Consolidation Docetaxel/Cisplatin in Patients With Locally Advanced Unresectable NSCLC (Stage IIIA-multiple cN2 or IIIB)
Brief Summary
  • Primary : To determine the safety profile of each treatment group.
  • Secondary : To determine efficacy in term of overall response, disease free survival and survival at 1 and 2 years.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small-Cell Lung Carcinoma
Intervention  ICMJE
  • Drug: docetaxel and cisplatin
    Docetaxel (75 mg/m2, IV, Day 1) and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles, followed by concurrent chemo-radiotherapy with docetaxel (20 mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy.
  • Radiation: radiotherapy
    Docetaxel (20 mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy followed by docetaxel (75 mg/m2, IV, Day 1) and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles.
Study Arms  ICMJE
  • Experimental: 1
    Induction chemotherapy followed by concurrent chemoradiotherapy
    Intervention: Drug: docetaxel and cisplatin
  • Active Comparator: 2
    Concurrent chemo-radiotherapy followed by consolidation chemotherapy
    Intervention: Radiation: radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 21, 2009)
14
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2007
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Informed consent form obtained, signed and dated before specific protocol procedures.
  2. Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma or a combination of these)
  3. Patients must have a loco regionally advanced unresectable NSCLC;

    • Stage IIIA with clinical multiple N2 nodes (preferably with histological or cytological confirmation).

      • Patients with peripheral tumours of the lower lobe with contralateral upper mediastinal nodes at station N2 are excluded·
    • Stage IIIB T4 or N3.

      • In the T4 category, patients with pleural or pericardial effusion and multiple nodules in the same lobe are excluded.
      • Patients with T4 disease secondary to extensive and massive involvement of the great vessels are excluded.Patients should be excluded when the expected risk of pulmonary toxicity is likely to be high, e.g. V20 in excess of 35%.
  4. Males or females aged between 18 and 75 years.
  5. Life expectancy of at least 12 weeks.
  6. WHO performance status 0 or 1.
  7. Weight loss <=10% within the last 3 months.
  8. Laboratory requirements at entry (within 7 days before randomization):

    • Blood cell counts:

      • Absolute neutrophils >= 2.0 x 10^9/L
      • Platelets >= 100 x 10^9/L
      • Hemoglobin >= 10 g/dl
    • Renal function:

      • Serum creatinine <=1 x the upper limit of normal (UNL). In case of borderline value of serum creatinine, the 24h creatinine clearance should be >= 60 mL/min.
    • Hepatic function:

      • Serum bilirubin <= 1 x UNL
      • ASAT and ALAT <= 2.5 x UNL
      • Alkaline phosphatase <= 5 x UNL Patients with ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase> 2.5 x UNL are not eligible for the study.
  9. Lung function tests at entry:

    • FEV1: >= 50 % x Normal value
    • DLCO: >= 50 % x Normal value
  10. Adequate cardiac function.
  11. Patient with either measurable and/or non-measurable lesion (according to RECIST criteria).

Exclusion Criteria:

  1. Diagnosis of small cell lung cancer.
  2. Pregnant or lactating women.
  3. Patients (male or female) with reproductive potential not implementing adequate contraceptive measures.
  4. Prior systemic chemotherapy, immunotherapy, or biological therapy including neoadjuvant or adjuvant treatment for NSCLC.
  5. Prior surgery for NSCLC, if less than 5 years from study.
  6. Prior radiotherapy for NSCLC.
  7. History of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years.
  8. Symptomatic peripheral neuropathy Grade >= 2 except if due to trauma.
  9. Other serious concomitant illness or medical conditions:

    • Congestive heart failure or angina pectoris except if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmias.
    • History of significant neurological or psychiatric disorders including dementia or seizures.
    • Active infection requiring IV antibiotics.
    • Active ulcer, unstable diabetes mellitus or other contra-indication to corticosteroid therapy.
    • Superior vena cava syndrome contra-indicating hydration.
    • Preexisting pericardial effusion.
    • Preexisting symptomatic pleural effusion.
  10. Significant gastrointestinal abnormalities, including requirement for intravenous nutrition, active peptic ulcer disease, prior surgical procedures affecting absorption.
  11. Distant metastasis.
  12. Concurrent treatment with any other experimental anti-cancer drugs.
  13. Concomitant or within 4-week period administration of any other experimental drug under investigation.
  14. Significant ophthalmologic abnormalities.
  15. Moderate to severe dermatitis.
  16. Hypersensitivity to docetaxel, cisplatin, or any of its excipients.
  17. Concomitant use of phenytoin, carbamazepin, barbiturates, or rifampicin.
  18. Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
  19. Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to return for follow-up visits, and not likely to complete the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00271323
Other Study ID Numbers  ICMJE XRP6976B_2507
EudraCT #: 2005-001276-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party "Medical Affairs Study Director", sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: M COUDERC, Dr Sanofi
PRS Account Sanofi
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP