Patients with histologically confirmed locally advanced or metastatic NSCLC (Stage IIIb/IV) without prior chemotherapy will be included. Patients must have at least one unidimensionally measurable lesion according to the RECIST criteria. CNS metastases, major surgery, chemotherapy or radiation therapy excluded in the previous 4 weeks are exclusion criteria.
Conditions
Interventions
Product Name: 5,6 Dimethylxanthenone-4-acetic acid
Product Code: AS1404
Pharmaceutical Form: Solution for infusion
Current Sponsor code: AS1404
Other descriptive name: DMXAA
Concentration unit: mg/ml
Sponsors
Antisoma Research Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically confirmed NSCLC Stage IIIb and IV Chemotherapy-naive patients (localised palliative irradiation is allowed) Patient is not a candidate for radical radiotherapy Minimum 18 years of age Have a Karnofsky performance status of equal or more that 70% Have a life expectancy of equal or more that 3 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Major surgery within the previous 4 weeks, chemotherapy or radiation therapy (except palliative) Hypersensitivity to paclitaxel, carboplatin or their excipients Previous exposure to DMXAA or other vascular targeting agents SCLC or mixed forms Receipt of blood infusions or growth factors within 2 weeks before baseline Active serious infections within 2 weeks before baseline Significant arrhythmias or known QTc prolongation Uncontrolled systemic disease Alcoholism, psychiatric disorder, pregnancy, childbearing potential or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determination of the safety, tolerability and efficacy of DMXAA in combination with carboplatin and paclitaxel in patients with locally advanced and metastatic (Stage IIIb and IV) NSCLC;Primary end point(s): Objective response rates (complete and partial), time to progression (TTP), duration of response and stable disease, median and one year survival.;Secondary Objective: Determine a safe dose of DMXAA when administered in combination with satandard carbopaltin and paclitaxel therapy Determine the safety and tolerability of the combination Measure the tumor response rate and time to progression Measure the duration of response and stable disease Measure median and one year survival Assess the potential for drug interaction between DMXAA and paclitaxel and carboplatin in combination. | — |
Countries
Germany
Outcome results
None listed