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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01350817
First received: May 9, 2011
Last updated: October 22, 2013
Last verified: October 2013

May 9, 2011
October 22, 2013
May 2011
May 2014   (final data collection date for primary outcome measure)
Progression free survival at 15 weeks. [ Time Frame: at 15 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01350817 on ClinicalTrials.gov Archive Site
  • Free survival at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Toxicities and feasibility [ Time Frame: 15 Weeks ] [ Designated as safety issue: Yes ]
    To assess toxicities and feasibility in both groups
Same as current
Not Provided
Not Provided
 
Erlotinib and Docetaxel in Second Line of Treatment in Patients With Non Small Cell Lung Cancer
Randomized Open Non Comparative Multicenter Phase II Study of Sequential Erlotinib With Docetaxel Versus Docetaxel Alone in Second Line of Treatment in Patients With Non Small Cell Lung Cancer After Failure of First Line Chemotherapy

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 .

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non Small Cell Lung Cancer
  • Drug: Erlotinib + docetaxel
    docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16
  • Drug: Docetaxel
    docetaxel :75 mg/m² IV day 1 every 3 weeks.
  • Active Comparator: Docetaxel
    Intervention: Drug: Docetaxel
  • Experimental: Erlotinib
    Intervention: Drug: Erlotinib + docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
156
December 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01350817
I10004
Yes
University Hospital, Limoges
University Hospital, Limoges
Hoffmann-La Roche
Study Chair: Alain Vergnengre, MD University Hospital, Limoges
University Hospital, Limoges
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP