Clinical trial NCT00300586: IFCT-GFPC 05.02 A Randomized Phase III Trial Assessing in Patients With Advanced Non-small Cell Lung Cancer
Official title: A Randomized Phase III Trial Assessing in Patients With Advanced Non-small Cell Lung Cancer Not Progressing on First Line Cisplatin-gemcitabine Chemotherapy Maintenance Chemotherapy With Gemcitabine or Sequential Treatment With Erlotinib
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stage IV Non-small Cell Lung Cancer
Keywords: Non-small cell lung cancer ;
metastatic ;
chemotherapy ;
erlotinib
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2006-03-09
Enrollment: 842
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this trial is to improve the duration of control disease for PS 0-1 patients who are not progressing on first-line cisplatin-gemcitabine chemotherapy. Standard therapy is for these patients to stop first-line chemotherapy after 4 to 6 cycles and to begin a second-line chemotherapy when progression of disease is occurring. Two approaches will be experimented in this trial in attempt to prolong progression free survival :

* Maintenance chemotherapy with single-agent gemcitabine continued till disease progression or toxicity.
* Sequential treatment with erlotinib immediately given after the end of first-line chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Histologically documented NSCLC (tumor tissue samples will be provided to look for assessment of EGFR status with CISH, immunochemistry and mutations) : adenocarcinoma, squamous cell carcinoma, large cell carcinoma. A cytological documentation of NSCLC is accepted.
* Stage IV disease or metastatic relapse in not previously irradiated areas of a NSCLC previously treated with surgery or radiation therapy (with a histologically documented proof of relapse) or stage III B with documented pleural involvement.
* Measurable disease according to the RECIST criteria.
* Prior radiotherapy authorized except for irradiation concerning measurable disease.
* Age \>18 and \< 70 years.
* PS \< 2.
* Normal hepatic function : serum bilirubin \< 1.5 ULN, SGOT (ASAT) and SGPT (ALAT) \< 2,5 ULN ; in presence of liver metastases, SGOT and SGPT must be \< 5 x ULN.
* Creatinine clearance \> 60 mL/min.
* Granulocyte count \> 1,5 giga/L, platelet count \> 100 giga/L.
* Life expectancy \> 12 weeks.
* Written (signed) informed consent for use of tumors samples.
* Written (signed) informed consent to participate in the sudy.

Exclusion Criteria:

* Small cell lung cancer, bronchiolo-alveolar carcinoma, neuro-endocrine carcinoma.
* PS \> 1.
* Prior chemotherapy other than cisplatin-gemcitabine.
* Prior therapy with EGFR inhibitor (e.g. monoclonal antibody).
* No concomitant therapy with phenytoin, carbamazepine, rifampicine or phenobarbital.
* Concomitant radiotherapy except for localized bone irradiation.
* Symptomatic brain metastases.
* Superior vena cava syndrome.
* Any unstable systemic disease : significant cardiovascular disease including myocardial infarction within the previous year, active infection, significant hepatic or renal disease.
* Pre-existing interstitial lung disease.
* Any inflammatory changes of the surface of the eyes.
* Psychiatric disease with inability to understand the study or to comply with follow-up procedures.
* Grade \> or = 2 peripheral neuropathy.
* Any other malignancies within 5 years (except for treated carcinoma in situ of the cervix or basal cell skin cancer).
* Pregnant or lactating women ; patients with reproductive potential must use effective contraception.
* Inability to comply with follow-up procedures.

Primary outcomes:
measure: Progression free survival since randomization
timeFrame: time until progression
Secondary outcomes:
measure: Overall survival,
timeFrame: no time limit
measure: toxicity (NCIC-CTC 3.0),
timeFrame: time until progression
measure: quality of life (as assessed by LCSS).
timeFrame: until progression
Other outcomes:
Locations:
city: Lyon
country: France
facility: Maurice PEROL
Study officials:
affiliation: Hospices Civils de Lyon
name: Maurice Pérol, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perol M, Chouaid C, Perol D, Barlesi F, Gervais R, Westeel V, Crequit J, Lena H, Vergnenegre A, Zalcman G, Monnet I, Le Caer H, Fournel P, Falchero L, Poudenx M, Vaylet F, Segura-Ferlay C, Devouassoux-Shisheboran M, Taron M, Milleron B. Randomized, phase III study of gemcitabine or erlotinib maintenance therapy versus observation, with predefined second-line treatment, after cisplatin-gemcitabine induction chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol. 2012 Oct 1;30(28):3516-24. doi: 10.1200/JCO.2011.39.9782. Epub 2012 Sep 4.