IFCT-GFPC 05.02 A Randomized Phase III Trial Assessing in Patients With Advanced Non-small Cell Lung Cancer
This study has been completed.
Information provided by (Responsible Party):
Hospices Civils de Lyon
First received: March 6, 2006
Last updated: December 28, 2011
Last verified: December 2011
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.
Stage IV Non-small Cell Lung Cancer
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Progression free survival since randomization [ Time Frame: time until progression ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival, [ Time Frame: no time limit ] [ Designated as safety issue: No ]
- toxicity (NCIC-CTC 3.0), [ Time Frame: time until progression ] [ Designated as safety issue: Yes ]
- quality of life (as assessed by LCSS). [ Time Frame: until progression ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2011 (Final data collection date for primary outcome measure)
Sham Comparator: A (supervision)
medical supervision, second line chemotherapy if progression
observation, second line chemotherapy if progression
Active Comparator: B (gemcitabicine)
Maintenance treatment (gemcitabicine 1250 mg/m² J1, J8 (repeated cycles every 21 days), second line chemotherapy if progression
1250 mg/m² D1, D8 q21 days
Experimental: C (Erlotinib)
Treatment by erlotinib 150 mg/day (sequential treatment), second line chemotherapy if progression
150 mg daily
|Ages Eligible for Study:
||18 Years to 70 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00300586
|Lyon, France, 69317 |
Hospices Civils de Lyon
||Maurice Pérol, MD
||Hospices Civils de Lyon
||Hospices Civils de Lyon
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 6, 2006
||December 28, 2011
||France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Keywords provided by Hospices Civils de Lyon:
Non-small cell lung cancer ;
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 28, 2016
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protein Kinase Inhibitors