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

A Multicenter, Randomized Phase II Study Evaluating the Feasibility and Activity of Two Different Combinations of Docetaxel and Gemcitabine and of Cisplatin/Gemcitabine Followed by Docetaxel as First Line Therapy for Locally Advanced Unresectable or Metastatic Non-small Cell Lung Cancer.

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.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Docetaxel and Gemcitabine; Drug: Docetaxel and Gemcitabine; Drug: Gemcitabine cisplatin followed by docetaxel

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • Sanofi-Aventis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: 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; 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.
Experimental: 2	Drug: 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; 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.
Experimental: 3	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response Rate	Performed after 3 cycles and at the end of treatment (6 cycles).

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to progression.	Time from treatment to the documented profession of disease.

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Georges Paizis, MD, Sanofi

Study record dates

Study Major Dates

• Study Start: July 1, 2002
• Primary Completion (Actual): April 1, 2005
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: January 19, 2007
• First Submitted That Met QC Criteria: January 19, 2007
• First Posted (Estimate): January 22, 2007

Study Record Updates

• Last Update Posted (Estimate): December 7, 2009
• Last Update Submitted That Met QC Criteria: December 4, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gemcitabine; Docetaxel
• Other Study ID Numbers: XRP6976B_2501

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No