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

NCT00300586 | Completed Phase 3 DMC

• 1 other identifier: 2005.386
• Study Type: interventional
• Target: 842
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage IV Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancer ;; metastatic ;; chemotherapy ;; erlotinib

Outcome Measures

Primary Outcomes (1)

• Progression free survival since randomization

  time until progression

Secondary Outcomes (3)

• Overall survival,

  no time limit

• toxicity (NCIC-CTC 3.0),

  time until progression

• quality of life (as assessed by LCSS).

  until progression

Study Arms (3)

A (supervision)

SHAM COMPARATOR

medical supervision, second line chemotherapy if progression

Drug: observation

B (gemcitabicine)

ACTIVE COMPARATOR

Maintenance treatment (gemcitabicine 1250 mg/m² J1, J8 (repeated cycles every 21 days), second line chemotherapy if progression

Drug: gemcitabine

C (Erlotinib)

EXPERIMENTAL

Treatment by erlotinib 150 mg/day (sequential treatment), second line chemotherapy if progression

Drug: erlotinib

Interventions

observation DRUG

observation, second line chemotherapy if progression

A (supervision)

gemcitabine DRUG

1250 mg/m² D1, D8 q21 days

B (gemcitabicine)

erlotinib DRUG

150 mg daily

C (Erlotinib)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Maurice PEROL

Lyon, 69317, France

Location

Related Publications (1)

• 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.

  PMID: 22949150 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Interventions

Observation; Gemcitabine; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Maurice Pérol, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2006
• First Posted: March 9, 2006
• Study Start: June 1, 2006
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 28, 2019

Record last verified: 2011-12

Locations

FR (1)