Pulmonart: Docetaxel - Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00174772
First received: September 12, 2005
Last updated: February 15, 2010
Last verified: February 2010
  Purpose

Primary Objective:

  • To evaluate the toxicity/safety profile of docetaxel/cisplatin induction therapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy followed by consolidation docetaxel/cisplatin in patients with locally advanced unresectable NSCLC (stage IIIA- multiple cN2 or IIIB).

Secondary Objective:

  • To estimate efficacy parameters in overall response rate, progression free survival and 1 year survival for each of the two above mentioned arms.

Condition Intervention Phase
Lung Neoplasms
Drug: docetaxel and cisplatin followed by concurrent chemoradiotherapy with docetaxel and cisplatin + radiotherapy
Drug: docetaxel and cisplatin + radiotherapy followed by docetaxel and cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Two Arm Phase II Study Comparing Docetaxel/Cisplatin Induction Therapy Followed By Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy Followed By Consolidation Docetaxel/Cisplatin in Patients With Locally Advanced Unresectable NSCLC (Stage IIIA-Multiple cN2 or IIIB)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • anti-tumor activity including overall response rate [ Time Frame: assessed at the end of the full course of treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • all treatment related acute and chronic toxicity assessed according to the NCI-CTC scale [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
  • other adverse events not reported in the NCI-CTI scale [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
  • hematological and non-hematological toxicities [ Time Frame: reported for all grades observed during each cycle ] [ Designated as safety issue: Yes ]

Enrollment: 72
Study Start Date: March 2004
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: B
Concurrent chemoradiotherapy followed by consolidation chemotherapy
Drug: docetaxel and cisplatin + radiotherapy followed by docetaxel and cisplatin
docetaxel (20mg/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 and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles.
Experimental: A
Induction chemotherapy followed by concurrent chemoradiotherapy
Drug: docetaxel and cisplatin followed by concurrent chemoradiotherapy with docetaxel and cisplatin + radiotherapy
docetaxel (75mg/m2, IV, Day 1) and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles, followed by concurrent chemoradiotherapy 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma or a combination of these)
  • Patients must have a locoregionally advanced unresectable NSCLC

    • Stage IIIA with multiple level clinical 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%.

  • Life expectancy of at least 12 weeks.
  • WHO performance status 0 or 1.
  • Weight loss ≤ 10% within the last 3 months.
  • 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 functions:

      • 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.

  • Lung function tests at entry:

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

Exclusion criteria:

  • Diagnosis of small cell lung cancer
  • Pregnant or lactating women
  • Patients (male or female) with reproductive potential not implementing adequate contraceptive measures
  • Prior systemic chemotherapy, immunotherapy, or biological therapy including neoadjuvant or adjuvant treatment for NSCLC
  • Prior surgery for NSCLC, if less than 5 years from study
  • Prior radiotherapy for NSCLC
  • 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.
  • Symptomatic peripheral neuropathy Grade ≥ 2 except if due to trauma.
  • Other serious concomitant illness of 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 neurologic 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.
  • Significant gastrointestinal abnormalities, including requirement for intravenous nutrition, active peptic ulcer disease, prior surgical procedures affecting absorption.
  • Distant metastasis.
  • Concurrent treatment with any other experimental anti-cancer drugs.
  • Concomitant or within 4-week period administration of any other experimental drug under investigation.
  • Significant ophthalmologic abnormalities.
  • Moderate to severe dermatitis.
  • Hypersensitivity to docetaxel or any of its excipients.
  • Concomitant use of phenytoin, carbamazepin, barbiturates, or rifampicin.
  • Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
  • Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.

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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174772

Locations
Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
Finland
Sanofi-Aventis Administrative Office
Helsinki, Finland
France
Sanofi-Aventis Administrative Office
Paris, France
Italy
Sanofi-Aventis Administrative Office
Milan, Italy
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Turkey
Sanofi-Aventis Administrative Office
Istanbul, Turkey
United Kingdom
Sanofi-Aventis Administrative Office
Guilford, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jean-Philippe Aussel Sanofi
  More Information

Publications:
Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00174772     History of Changes
Other Study ID Numbers: XRP6976B_2505
Study First Received: September 12, 2005
Last Updated: February 15, 2010
Health Authority: Netherlands: Medicines Evaluation Board (MEB)

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014