Erlotinib and Docetaxel in Second Line of Treatment in Patients With Non Small Cell Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This 2 arms study will compare the efficacy and safety of treatment with sequential erlotinib plus docetaxel therapy versus docetaxel alone as second line treatment in patients with recurrent non-small cell lung cancer. Patients will be randomized to receive in group 1(experimental arm): docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16 and group 2 (control arm): docetaxel :75 mg/m² IV day 1 every 3 weeks.

The anticipated time on study treatment is until disease progression. Target sample size is 156.

The main of this study is to determine the relevance of the association sequential erlotinib and docetaxel in terms of progression-free survival .

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Erlotinib and Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Failure of One Chemotherapy Regimen

NCT00908336

Non-Small Cell Lung Cancer

UNKNOWN PHASE2

Study of Erlotinib With Docetaxel in Selected Non Small Cell Lung Cancer Patients in First Line Treatment

NCT00840125

Non-Small Cell Lung Cancer

COMPLETED PHASE2

Elderly Independent Patients With Non Small Cell Lung Cancer (NSCLC)

NCT00418704

Non Small Cell Lung Cancer

COMPLETED

Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer

NCT00075517

Lung Cancer

UNKNOWN PHASE2

2nd Line Erlotinib Treatment With (Out) Chemotherapy of Advanced Non Small Cell Lung Cancer (NSCLC)

NCT00835471

Carcinoma, Non-Small-Cell Lung

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this study, the patient will be randomized in group 1(experimental arm): docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16 and group 2 (control arm): docetaxel :75 mg/m² IV day 1 every 3 weeks.

Assessment during treatment: Physical examination, ECG,: every 3 weeks, laboratory tests: weekly, every 3 weeks pulmonary X-ray .The CT scans:. Measurable targets are assessed by RECIST compared to the beginning of treatment: at 6 weeks (day 42 EVA 2), 12 weeks (D84 EVA 3), 15 weeks (D105 EVA 4: Evaluation of the SSP) and then every 6 weeks until progression.

Quality of life will be assessed Day 42 then every 6 weeks during chemotherapy, Tolerability will be assessed at each visit based on CTC v4.0 criteria.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non Small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Docetaxel

Group Type ACTIVE_COMPARATOR

Docetaxel

Intervention Type DRUG

docetaxel :75 mg/m² IV day 1 every 3 weeks.

Erlotinib

Group Type EXPERIMENTAL

Erlotinib + docetaxel

Intervention Type DRUG

docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Erlotinib + docetaxel

docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16

Intervention Type DRUG

Docetaxel

docetaxel :75 mg/m² IV day 1 every 3 weeks.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically proven NSCLC (
* Mutational status of EGFR : wild type or unknown
* Stage IV disease with cytologic or histologic documentation in patients with a single easily accessible metastasis or metastatic relapses in a non irradiated region from a primary tumor treated with surgery or radiotherapy (with cytologic or histologic documentation of relapse)
* Presence of at least one measurable target lesion (one dimension) in a non irradiated region (at least 10 mm on spiral computed tomography).
* Age ≥ 18 years
* Performance status 0,1,2 exception : age \> 74 years only PS 0 or 1
* Normal hepatic function
* Normal renal function
* Normal calcemia
* Normal haematological function
* Life expectancy \> 12 weeks.
* Women of child bearing potential must use effective contraception.
* Men might be surgically sterile or accept to use an effective contraceptive procedure during and until 6 months after the treatment.
* Written informed consent to participate in the study.

Exclusion Criteria

* PS \> 2, exception : age \> 74 years only PS ≥ 2
* Presence of another cancer
* Previous treatment with an anti egfr agent or docetaxel
* QT prolongation (\>470 ms)
* Uncontrolled arterial hypertension.
* Concurrent radiotherapy, except for palliative bone irradiation.
* Stroke less than 6 months before study entry.
* Psychiatric or neurological disorders preventing the patient from understanding the nature of the trial
* Uncontrolled infection.
* Caval syndrome
* Other organic disorders preventing inclusion in the trial
* Malabsorption syndrome
* Allergy to erlotinib or one of its constituents
* Allergy to docetaxel or one of its constituents
* Pregnancy and breast-feeding
* Surgery less than two months before study entry

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No