Phase I Combination With Vinorelbine or Gemcitabine Plus Cisplatin in Locally Advanced or Metastatic NSCLC

Genzyme, a Sanofi Company17 enrolled

Overview

To test the safety and tolerability of ZD6474 in combination withVinorelbine (Navelbine) or Gemcitabine (Gemzar) plus cisplatin as first line therapy in patients with locally advanced or metastatic (Stage IIIB-IV) Non Small Cell Lung Cancer.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non Small Cell Lung Cancer

Interventions

Zactima (ZD6474)DRUG

Vinorelbine plus cisplatinDRUG

Gemcitabine plus cisplatinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Confirmed non small cell lung cancer (stage IIIB-IV) * Life expectancy greater than 12 weeks * At least 1 measurable lesion greater than 10mm in smallest diameter. Exclusion Criteria: * Prior treatment with anticancer agent * Brain metastases * Major surgery within last 4 weeks

Outcomes

Primary Outcomes

Establish safety and tolerability of ZACTIMA in combination with vinorelbine plus cisplatin or gemcitabine plus cisplatin

Secondary Outcomes

Pharmacokinetics of ZACTIMA, vinorelbine or gemcitabine, plus cisplatin when co-administered

Time frame: Predetermined timepoints after dose administration

Preliminary assessment of efficacy of ZACTIMA when co-administered with vinorelbine plus cisplatin or gemcitabine plus cisplatin

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.