Oral Vinorelbine as Induction Chemotherapy Followed Concomitant Chemoradiotherapy

Lung Cancer Clinical Trial

Official title:

A Phase II Study of Cisplatin With Intravenous and Oral Vinorelbine as Induction Chemotherapy Followed by Concomitant Chemotherapy With Oral Vinorelbine and Cisplatine for Locally Advances Non-small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839032
• Other study ID #: 041316
• Status: Completed
• Phase: Phase 2
• First received: April 5, 2013
• Last updated: April 19, 2013
• Start date: May 2005
• Est. completion date: October 2008

Study information

• Verified date: April 2013
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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).

Description:

Vinorelbine (NVB) + CDDP is considered a standard trt in induction or concomitantly with RT (Vokes, Fournel, Krzakowski). NVBo simplifies the administration of trt and provides the same efficacy as intravenous NVB (NVBiv). In order to assess this and to improve the tolerance, a trial was started with NVBiv and NVBo + CDDP as induction followed by a fractionated administration of NVBo + CDDP during RT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Drug:
• Vinorelbine cisplatin radiotherapy
During the induction period, patients received chemotherapy for two 3-week cycles. Bolus intravenous vinorelbine 25 mg/m², was administered on day 1, then cisplatin 80 mg/m² was administered over 1-hour infusion. Vinorelbine 60 mg/m² was also administered on day 8. Patients with objective response (OR) or no change (NC) continued the concomitant period (CP) including two additional 3-week cycles of radio chemotherapy (vinorelvine 20 mg D1 D3 D5 Cisplatin 80 mg/m² 66 Gy).

Locations

Country	Name	City	State
France	CHU CAEN	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	- progression-free survival (PFS)		up to 3 years	No
Other	- overall survival (OS),		up to 3 years	No
Other	- safety		up to 3 years	Yes
Primary	Disease controle		up to 3 years	No
Secondary	- duration of response (DR)	Secondary endpoints were duration of response (DR), progression-free survival (PFS), and overall survival (OS), calculated by the Kaplan-Meier method. The safety analysis reported the worst grade of the adverse events (NCI CTC v. 2.0) for the safety population.	up to 3 years	No