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
|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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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
No publications provided
||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 October 22, 2014
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protein Kinase Inhibitors