Status:
COMPLETED
IFCT-GFPC 05.02 A Randomized Phase III Trial Assessing in Patients With Advanced Non-small Cell Lung Cancer
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Stage IV Non-small Cell Lung Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 pa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
842 Patients enrolled
Trial Details
Trial ID
NCT00300586
Start Date
June 1 2006
End Date
March 1 2011
Last Update
May 28 2019
Active Locations (1)
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1
Maurice PEROL
Lyon, France, 69317