Oral Vinorelbine as Induction Chemotherapy Followed Concomitant Chemoradiotherapy

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients (pts) with stage IIIA/IIIB NSCLC received NVBiv 25 mg/m² + CDDP 80 mg/m² on D1 and NVBo 60 mg/m² on D8 every 3 weeks (q3w) for 2 cycles as induction. Pts with response or non change received NVBo 20 mg fixed dose on D1 D3 D5 + CDDP 80 mg/m² on D1 q3w for 2 more cycles during RT(66 Gy/6.5 w).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pierre Fabre Medicament
• Treatments: Cisplatin; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• histologically or cytologically confirmed stage IIIA (only N2),

• dry IIIB previously untreated inoperable NSCLC,

• 18 to 75 years old,

• Karnofsky Performance Status (KPS) ≥ 80%,

• weight loss ≤ 10% within the previous 3 months,

• normal organ functions were eligible.

• at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) [10].

Exclusion Criteria:

• stages I, II, IIIA (excepted N2), IIIB with pleural effucion and stage IV,

• pregnant or breastfeeding women. Women of Childbearing Age: Women of childbearing potential should take reliable contraceptive measures

• Symptomatic Neuropathy > grade 1,

• associated Pathology and/or not controled diseases(cardiac insuficiency, myocardial infarction within 3 months before the inclusion ; hypertension, arythmia or uncontroled hypercalcémia; infection requiering iv antibiotic administration within 2 weeks before inculion),

• other associated cancer with the exception of cervical carcinoma in situ or skin cancer baso-cellular correctely treated,

• Previous treatment with an other antineoplasic,

• Known hypersensibility to drugs with a similar chemical structure ti this studied.

• important malabsorbtion syndrom or disease of gastro-intestinal track,

• Participation to another clinical trial within 30 days before inclusion