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

NCT ID: NCT00425191

Last Updated: 2009-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Docetaxel and Gemcitabine

Intervention Type: 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

2

Group Type: EXPERIMENTAL

Docetaxel and Gemcitabine

Intervention Type: DRUG

Docetaxel: 50 mg/m², administered IV over 60 minutes (infusion drop by drop during the first five minutes) on day 1 and 15 immediately followed by Gemcitabine: 1600 mg/m2, administered IV over 30 minutes on day 1 and 15.

3

Group Type: EXPERIMENTAL

Gemcitabine cisplatin followed by docetaxel

Intervention Type: 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

Interventions

Docetaxel and Gemcitabine

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

Intervention Type: DRUG

Docetaxel and Gemcitabine

Docetaxel: 50 mg/m², administered IV over 60 minutes (infusion drop by drop during the first five minutes) on day 1 and 15 immediately followed by Gemcitabine: 1600 mg/m2, administered IV over 30 minutes on day 1 and 15.

Intervention Type: DRUG

Gemcitabine cisplatin followed by docetaxel

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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);

Exclusion Criteria

• 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;
• Active infection requiring iv antibiotics;
• Active ulcer, unstable diabetes mellitus or other contra-indication to corticotherapy;
• Any other condition, which in the judgement of the investigator would place the subject at, undoes risk or interferes with the study.
• Treatment with biphosphonates.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Georges Paizis, MD

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Milan, , Italy

Countries

Italy

Other Identifiers

XRP6976B_2501

Identifier Type: -

Identifier Source: org_study_id