IFCT-GFPC 05.02 A Randomized Phase III Trial Assessing in Patients With Advanced Non-small Cell Lung Cancer

Stage IV Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00300586
• Other study ID #: 2005.386
• Status: Completed
• Phase: Phase 3
• Start date: June 2006
• Est. completion date: March 2011

Study information

• Verified date: December 2011
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 842
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Stage IV Non-small Cell Lung Cancer

Intervention

Drug:
• observation
observation, second line chemotherapy if progression
• gemcitabine
1250 mg/m² D1, D8 q21 days
• erlotinib
150 mg daily

Locations

Country	Name	City	State
France	Maurice PEROL	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & Publications (1)

Pérol M, Chouaid C, Pérol D, Barlési F, Gervais R, Westeel V, Crequit J, Léna H, Vergnenègre A, Zalcman G, Monnet I, Le Caer H, Fournel P, Falchero L, Poudenx M, Vaylet F, Ségura-Ferlay C, Devouassoux-Shisheboran M, Taron M, Milleron B. Randomized, phase — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival since randomization		time until progression
Secondary	Overall survival,		no time limit
Secondary	toxicity (NCIC-CTC 3.0),		time until progression
Secondary	quality of life (as assessed by LCSS).		until progression