None listed
Conditions
Interventions
REFRACTORY TO PLATINUM Type of group
Brostalicin 10 mg / m2 I.V. in infusion of 10 minutes every 3 weeks
Group name:RESISTANT TO PLATINUM Type of group
Brostalicin 10 mg / m2 I.V. in infusion of 10 minutes every 3 weeks
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Eligibility
Inclusion criteria
Inclusion criteria: • Patients must have a diagnosis of NSCLC demonstrated histologically or cytologically, indicating that they are at the locally advanced stage of metastasis (stage IIIB or IV), which was refractory or resistant to a previous therapy based on platinum. • Patients must have a disease that does not require surgery or radiation or a combined form of therapy for healing purposes. Palliative irradiation is allowed, as long as it is not applied to the white lesion (s). • Patients must be ^ 18 years of age. • Patients must have a performance status on the ECOG scale, <2. • Patients must have a life expectancy of more than 3 months.
Exclusion criteria
Exclusion criteria: 1. Concomitant treatment with any other agent in the Research phase. Patients who have received more than one chemotherapy regimen for NSCLC, either as adjuvant / neoadjuvant therapy or as a treatment for locoregional or stage IV disease. 3. Known leptomeningeal or cerebral disease (documented by computed tomography [CT] or by magnetic resonance imaging (MRI) of the brain, required only in case of clinical suspicion of central nervous system [CNS] involvement). 4. Patients with previous malignancies (in the last 5 years) or current ones in other sites. 5. Patients who have previously received high doses of chemotherapy, with support from bone marrow cells or progenitor cells. 6. Patients who have received irradiation in 25% of their bone marrow.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:• Time and duration of the tumor response, time to present the tumor failure (TTP), and the time of survival • Signs and symptoms related to the tumor • Safety profile (based on the assessment of the incidence and intensity of adverse events [rated according to the Common Toxicity Criteria (CTC) of the National Cancer Institute (NCI), version 2.0], as well as chronicity and cumulative nature • Treatment management, that is, the dosage level • Evaluation of the plasma pharmacokinetic profile of PNU-166196 Measure:Time and duration of the response, the time in which the therapeutic fails, the time in which the tumor progresses and the time of survival. Safety and tolerability of brostalicin in patients with advanced NSCLC, refractory or resistant to platinum-based therapy and evaluate the pharmacokinetic profile of brostalicin. Timepoints:each 2 months | — |
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Evaluation of the objective response rate (RR) on the tumor. The one-dimensional measurement system of the tumor response will be used, through the Response Criteria in Solid Tumors (RECIST), to evaluate the responses. Measure:Determine the objective tumor response rate (RR). The Response Criteria in Solid Tumors (RECIST) will be used for the one-dimensional measurement of the tumor response. Timepoints:Every 2 months | — |
Countries
Peru, United States
Outcome results
None listed