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

NCT00271323 | Terminated Phase 2

• 2 other identifiers: XRP6976B_2507EudraCT #: 2005-001276-12
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small-Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (3)

• overall response rate

  in population of patients eligible and evaluable for response

• time to progression

  from the date of start treatment until progression

• duration of response

  only on responders

Study Arms (2)

1

EXPERIMENTAL

Induction chemotherapy followed by concurrent chemoradiotherapy

Drug: docetaxel and cisplatin

2

ACTIVE COMPARATOR

Concurrent chemo-radiotherapy followed by consolidation chemotherapy

Radiation: radiotherapy

Interventions

docetaxel and cisplatin DRUG

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.

1

radiotherapy RADIATION

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.

2

Eligibility Criteria

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

You may qualify if:

• Informed consent form obtained, signed and dated before specific protocol procedures.
• Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma or a combination of these)
• 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%.
• Males or females aged between 18 and 75 years.
• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Paris, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel; Cisplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Study Officials

• M COUDERC, Dr

  Sanofi

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 29, 2005
• First Posted: December 30, 2005
• Study Start: May 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: December 23, 2009

Record last verified: 2009-12

Locations

FR (1)