Randomized Phase II Trial of Two Sequential Schedules of Docetaxel and Cisplatin Followed by Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer.

Sanofi1 site in 1 country88 target enrollmentMay 2005

ConditionsCarcinoma, Non-Small-Cell Lung

Interventionsdocetaxel and cisplatin followed by gemcitabine

DrugsDocetaxel and cisplatin followed by gemcitabine docetaxel and cisplatin followed by gemcitabine

Overview

Phase: Phase 2
Intervention: docetaxel and cisplatin followed by gemcitabine
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Sanofi
Enrollment: 88
Locations: 1
Primary Endpoint: overall response rate assessed by RECIST criteria.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, open-label, randomized phase II trial whose aim is to assess the antitumor activity of two sequential schedules of docetaxel and cisplatin followed by gemcitabine.

Registry

clinicaltrials.gov

Start Date

May 2005

End Date

August 2008

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically confirmed diagnosis of NSCLC; Histologic subtypes may include large cell, squamous cell, or adenocarcinoma or a generic cytological diagnosis of NSCLC;
•Patients must have a locoregionally advanced unresectable non metastatic NSCLC Stage IIIB (only N3 supraclavicular or T4 for pleural effusion) or Stage IV according to the revised International Staging System;
•Patients must have at least one measurable lesion according to RECIST criteria.
•Previous radical surgery (more 30 days before study entry) is allowed but a pathologic proof of progression of neoplastic disease must be documented;
•WHO Performance Status 0 or 1 ;
•Weight loss \< 5% within the last 3 months;
•Laboratory requirements at entry
•Blood cell counts: Absolute neutrophils \> 2.0 . 10\^9/L; Platelets \> 100 . 10\^9/L; Hemoglobin \> 10 g/dl
•Renal function: Serum creatinine \< 1 upper normal limits (UNL). In case of limit value of serum creatinine, the creatinine clearance should be \> 60 mL/min
•Hepatic functions: Serum bilirubin \< 1 x UNL; ASAT and ALAT \< 2.5 x UNL; Alkaline phosphatase \< 5 x UNL (unless accompanied by extensive bone metastases)

Exclusion Criteria

•Prior systemic chemotherapy or immunotherapy ; prior neoadjuvant or adjuvant chemotherapy is allowed if ended at least 12 months before enrollment;
•Prior radiotherapy for NSCLC to measurable lesions. Prior radiotherapy (to \< 25% of the bone marrow) is allowed in non target lesions. At least 4 weeks must be elapsed since the completion of the radiotherapy and the patient must have all side effects recovered.
•Cyto-histological diagnosis of small cell lung cancer, carcinoid, or mixed small-cell / non-small cell lung cancer;
•Patients with evaluable, not measurable disease only (non target lesions);
•Patients with symptomatic brain metastases or with leptomeningeal disease;
•History of prior malignancies, except for cured non melanoma skin cancer, curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years;
•History of hypersensitivity reaction to polysorbate 80;
•Pregnant or lactating women (women of childbearing potential must use adequate contraception);
•Current peripheral neuropathy NCI grade \> 2;
•Significant neurological or psychiatric disorders ;

Arms & Interventions

A

Intervention: docetaxel and cisplatin followed by gemcitabine

B

Intervention: docetaxel and cisplatin followed by gemcitabine

Outcomes

Primary Outcomes

overall response rate assessed by RECIST criteria.

Time Frame: before, during and at the end of treatment

Secondary Outcomes

Time to progression(from the date of randomization to the date of first documented tumor progression or relapse)
time to treatment failure(from the date of treatment start to the date of diagnosis of progression, withdrawal from study treatment for any reason, administraztion of other antitumor treatment, or death for any cause)
overall survival(time interval from the date of randomisation to the date of death)