IFCT-GFPC 05.02 A Randomized Phase III Trial Assessing in Patients With Advanced Non-small Cell Lung Cancer
Phase 3
Completed
- Conditions
- Stage IV Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00300586
- Lead Sponsor
- Hospices Civils de Lyon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 842
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A (supervision) observation medical supervision, second line chemotherapy if progression B (gemcitabicine) gemcitabine Maintenance treatment (gemcitabicine 1250 mg/m² J1, J8 (repeated cycles every 21 days), second line chemotherapy if progression C (Erlotinib) erlotinib Treatment by erlotinib 150 mg/day (sequential treatment), second line chemotherapy if progression
- Primary Outcome Measures
Name Time Method Progression free survival since randomization time until progression
- Secondary Outcome Measures
Name Time Method Overall survival, no time limit toxicity (NCIC-CTC 3.0), time until progression quality of life (as assessed by LCSS). until progression
Trial Locations
- Locations (1)
Maurice PEROL
🇫🇷Lyon, France