Multicenter Phase II Study Evaluating Docetaxel and CDDP as Induction Regimen Prior to Surgery or Radiochemotherapy With Docetaxel, Followed by Adjuvant Docetaxel Therapy in Chemonaive Patients With NSCLC Stage II, IIIa and IIIb

Sanofi1 site in 1 country80 target enrollmentMay 2001

ConditionsCarcinoma, Squamous Cell

Interventionsdocetaxel + CDDP

DrugsDocetaxel + CDDP docetaxel + CDDP

Overview

Phase: Phase 2
Intervention: docetaxel + CDDP
Conditions: Carcinoma, Squamous Cell
Sponsor: Sanofi
Enrollment: 80
Locations: 1
Primary Endpoint: To assess the response rate to induction therapy with docetaxel in combination with CDDP
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Primary objective:

• To assess the response rate to induction therapy with docetaxel/CDDP.

Secondary objectives:

To assess

Resectability after induction therapy
Time to progression
Overall survival
Safety profile
Quality of Life

Registry

clinicaltrials.gov

Start Date

May 2001

End Date

October 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

Eligibility Criteria

Inclusion Criteria

•Histology and staging of the disease
•Histologically or cytologically confirmed NSCLC; histology may include: large cell, squamous cell or adenocarcinoma but no SCLC
•Resectable or unresectable NSCLC stage II (T1-2 N1, T3 N0) or stage IIIa (T1-2 N2 or T3 N1-2) or stage IIIb (T1-3 N3 or T4 N0-3)
•Measurable disease (bidimensionally or unidimensionally according to WHO criteria)
•General conditions
•Karnofsky Status \> 70, if age \> 70 years → PS \> 70
•Adequate hematological function (Hb \> 10 g/dl, ANC \> 2.0 x 109/L, platelets \> 100 x 109/L)
•Adequate renal and hepatic functions: total bilirubin \< 1 x upper normal limit (UNL), serum creatinine \< 1 x UNL, in case of limit value the creatinine clearance should be \> 60 ml/min, ASAT and ALAT \< 2.5 x UNL, alkaline phosphatase \< 5 x UNL.

Exclusion Criteria

•Evidence of brain metastases or other distant metastasis equivalent to stage IV disease
•History of prior malignancies, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix or other curatively treated cancer with no evidence of disease for at least five years
•Other serious concomitant illness or medical condition:
•Congestive heart failure or angina pectoris, except if medically controlled, history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmia
•History of significant neurologic or psychiatric disorders, including dementia or seizure
•Active infection requiring i.v. Antibiotics
•Active ulcer, unstable diabetes mellitus or other contraindications to corticotherapy
•Hepatic function abnormality: ASAT and/or ALAT \> 1.5 x UNL associated with alkaline phosphatase \> 2.5 x UNL
•Current peripheral neuropathy WHO grade \> 2
•Prior or concurrent therapy

Arms & Interventions

1

Resectable NSCLC

Intervention: docetaxel + CDDP

2

Unresectable NSCSC

Intervention: docetaxel + CDDP

Outcomes

Primary Outcomes

To assess the response rate to induction therapy with docetaxel in combination with CDDP

Time Frame: every 3 months until tumour progression and thereafter every 6 months until death

Secondary Outcomes

Safety profile(throughout the study)
Quality of life(every 3 months until tumour progression and thereafter every 6 months until death)
Resectability after induction therapy(every 3 months until tumour progression and thereafter every 6 months until death)
Time to progression(every 3 months until tumour progression and thereafter every 6 months until death)
Overall survival(every 3 months until tumour progression and thereafter every 6 months until death)