GILT Docetaxel - Non-Small Cell Lung Cancer

NCT00174629 | Completed Phase 3

• 1 other identifier: TAX_ES1_302
• Study Type: interventional
• Target: 449
• Locations: 3 countries
• Sites: 3

Brief Summary

Primary Objective:

• To compare response rate between genotypic groups and control group. Secondary Objective:
• To determine the safety, time to treatment failure and survival in control and genotypic arms.

Conditions

Lung Neoplasms

Outcome Measures

Primary Outcomes (1)

• Overall response rate (complete plus partial responses) between the genotypic group and the control group using an intent-to-treat analysis.

Secondary Outcomes (3)

• Time to treatment failure and survival

  calculated from the registration date until progression or death, respectively

• Clinical and laboratory toxicities graded according to NCIC-CTG Expanded Common Toxicity Criteria.

  before each cycle

• Adverse events not reported in NCIC-CTG Expanded Common Toxicity Criteria will be graded as mild, moderate, severe, and life threatening.

  Throughout the study

Study Arms (2)

1

EXPERIMENTAL

Drug: docetaxel/gemcitabine

2

ACTIVE COMPARATOR

Drug: Docetaxel/DDP

Interventions

Docetaxel/DDP DRUG

2

docetaxel/gemcitabine DRUG

1

Eligibility Criteria

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

You may qualify if:

• Patients must be/have:
• histologically confirmed non-small cell lung cancer (squamous cell carcinoma, large cells or adenocarcinoma; it is recommended to provide the full paraffin-embedded block or at least 5 5 sections obtained from the primary tumor, recurrence or metastasis, not stained, fixed in formalin/embedded in paraffin, mounted on slides (10 micron sections), as well as two serum samples in two 10-ml tubes and two blood samples (see appendix X);
• unresectable metastatic (stage IV or IIIB malignant pleural effusion) NSCLC;
• WHO performance status \< 2;
• Adequate bone marrow, hepatic and renal functions, assessed during the previous 14 days, that should be shown by the following characteristics:
• hemoglobin \> or = 10g/dl and no blood cell transfusion within the previous 2 weeks;
• absolute neutrophil count \> 2.0 10\^9 cells/l;
• platelet count \> or = 100.10\^9 cells/l;
• no evidence of myelodysplastic syndrome or abnormal bone marrow reserve;
• creatinine \< or = 1.5 x UNL or creatinine clearance \> or = 60 ml/min (real or calculated);
• total bilirubin \< or = UNL;
• ASAT (SGOT) and/or ALAT (SGPT) \< or = 1.5 x UNL;
• alkaline phosphatases \< or = 5 x UNL;
• serum calcium \< or = 1.1 x UNL;
• at least one measurable lesion;

You may not qualify if:

• pregnant or lactating women (women of childbearing potential must use adequate contraception);
• prior systemic chemotherapy or immunotherapy for NSCLC, even as neoadjuvant or adjuvant therapy;
• prior malignancies, except cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with non-evidence of disease for at least 5 years;
• history or clinical symptomatic brain or leptomeningeal metastases;
• current peripheral neuropathy and neurohearing \> or = NCIC-CTG grade 2 except if due to trauma;
• other serious illness or medical condition, including:
• congestive heart disease; prior myocardial infarction within 6 months;
• history of significant neurologic or psychiatric disorders that would inhibit their understanding and giving of informed consent;
• infection requiring I.V. antibiotics and tuberculosis under treatment ongoing at study entry;
• untreated superior vena cava syndrome;
• active peptic ulcer; unstable diabetes mellitus or other contraindication to high dose corticotherapy such as herpes, herpes zoster, cirrhosis;
• hypercalcemia requiring therapy;
• preexisting ascitis and/or clinical significant pericardial effusion;
• patients whose lesion(s) are assessable only by radionuclide scan;
• history of allergy to drugs containing the excipient TWEEN 80®;

Sponsors & Collaborators

• Sanofi: lead

Study Sites (3)

Sanofi-Aventis

Berlin, Germany

Location

Sanofi-Aventis

Barcelona, Spain

Location

Sanofi-Aventis

Geneva, Switzerland

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Docetaxel; Gemcitabine

Condition Hierarchy (Ancestors)

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

• Jean-Philippe Aussel

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: June 1, 2001
• Primary Completion: January 1, 2007
• Last Updated: December 7, 2009

Record last verified: 2009-12

Locations

CH (1); ES (1); DE (1)