Taxotere Combinations as First Line Therapy for Locally Advanced Unresectable or Metastatic Non-small Cell Lung Cancer.

NCT00425191 | Completed Phase 2

• 1 other identifier: XRP6976B_2501
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the antitumour activity (response rate) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) of two different combinations of docetaxel and gemcitabine and of a sequential treatment of cisplatin /gemcitabine followed by docetaxel as first line chemotherapy · To evaluate the quantitative and qualitative toxicity of each treatment arms.· To determine time to progression, duration of response, time to treatment failure, and overall survival in each group.· To evaluate changes from baseline in the Lung Cancer Symptom Scale of patients in each treatment arm.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Response Rate

  Performed after 3 cycles and at the end of treatment (6 cycles).

Secondary Outcomes (1)

• Time to progression.

  Time from treatment to the documented profession of disease.

Study Arms (3)

1

EXPERIMENTAL

Drug: Docetaxel and Gemcitabine

2

EXPERIMENTAL

Drug: Docetaxel and Gemcitabine

3

EXPERIMENTAL

Drug: Gemcitabine cisplatin followed by docetaxel

Interventions

Docetaxel and Gemcitabine DRUG

Docetaxel: 40 mg/m², administered IV over 60 minutes (infusion drop by drop during the first five minutes) on day 1 and 8 immediately followed by Gemcitabine: 1200 mg/m2, administered IV over 30 minutes on day 1 and 8

1

Gemcitabine cisplatin followed by docetaxel DRUG

Gemcitabine: 1200 mg/m2, administered IV over 30 minutes on day 1 and 8 followed by Cisplatin 75 mg/m2, administered IV over 30-60 minutes on day 2

3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed diagnosis of NSCLC istologic subtypes may include large cell, squamous cell, or adenocarcinoma or a generic cytological diagnosis of NSCLC;
• Patients must have a locoregionally advanced unresectable non metastatic NSCLC Stage IIIB (only N3 supraclavicular or T4 for pleural effusion) or Stage IV according to the revised International Staging System
• Patients must have at least one measurable lesion;
• Previous radical surgery (more 30 days before study entry) is allowed but a pathologic proof of progression of neoplastic disease must be documented whenever possible;
• Weight loss \< = 5% within the last 3 months;
• Laboratory requirements at entry :
• Blood cell counts: Absolute neutrophils \> 2.0 x 109/LPlatelets \> 100 x 109/LHemoglobin \> 10 g/dl
• Renal function:Serum creatinine \< 1 upper normal limits (UNL). In case of limit value of serum creatinine, the creatinine clearance should be \> 60 mL/min
• Hepatic functions:Serum bilirubin \< 1 x UNLASAT and ALAT \< 2.5 x UNLAlkaline phosphatase \< 5 x UNL (unless accompanied by extensive bone metastases);

You may not qualify if:

• Prior systemic chemotherapy or immunotherapy including neoadjuvant or adjuvant treatments;
• Prior radiotherapy for NSCLC;
• Cyto-histological diagnosis of small cell lung cancer, carcinoid, or mixed small-cell / non-small cell lung cancer;
• Patients with not measurable disease only;
• Patients with symptomatic brain metastases or with leptomeningeal disease. However; patients with symptomatic brain metastases who become asymptomatic under corticosteriods treatment can enter the study;
• 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;
• History of hypersensitivity reaction to polysorbate 80;
• Pregnant or lactating women (women of childbearing potential must use adequate contraception);
• Concurrent treatment with other experimental drugs;
• Current peripheral neuropathy NCI grade \> = 2;
• Significant neurological or psychiatric disorders;
• Hepatic functions abnormalities;
• Participation in clinical trials with other experimental agents within 30 days of study entry;
• Other serious concomitant illness of medical conditions;
• History of significant neurologic or psychiatric disorders including demential or seizures;

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Milan, Italy

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel; Gemcitabine

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; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Georges Paizis, MD

  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: January 19, 2007
• First Posted: January 22, 2007
• Study Start: July 1, 2002
• Primary Completion: April 1, 2005
• Last Updated: December 7, 2009

Record last verified: 2009-12

Locations

IT (1)