Conditions: Non-Small Cell Lung Cancer
Keywords: Advanced Non-Small Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 518
Healthy volunteers: no

Brief summary:
The primary objective of this trial is to compare the survival of patients with advanced non-small cell lung cancer (NSCLC) treated with weekly Taxoprexin in combination with carboplatin to those treated with paclitaxel plus carboplatin in a prospectively randomized trial. In addition, the response rate to each regimen, response duration, time to progression and time to treatment failure will be measured. Toxicity will be evaluated and compared between the two groups.

Detailed description:
This is a randomized, multicenter, Phase III open-label study of weekly Taxoprexin® in combination with every three (3) week carboplatin compared to paclitaxel plus carboplatin every three (3) weeks, in patients with advanced non-small cell lung cancer (NSCLC) who have not received cytotoxic agents for advanced disease. Patients may have been previously treated with immunological agents. Patients will be randomized to receive Taxoprexin® at a dose of 400 mg/m2 intravenously by one (1)-hour weekly infusion, 5/6 weeks followed immediately by carboplatin AUC = 4 on weeks one (1) and four (4) as a 30 minute intravenous infusion or paclitaxel 225mg/m2 as a three (3) hour intravenous infusion followed immediately by carboplatin AUC = 6 as a 30 minute intravenous infusion, every three (3) weeks. Patients will receive Taxoprexin® and carboplatin infusions or paclitaxel and carboplatin infusions until progression of disease, intolerable toxicity, completion of six (6) treatment cycles of paclitaxel plus carboplatin or three (3) treatment cycles of Taxoprexin® plus carboplatin, refusal of continued treatment by the patient, or Investigator decision.

Arms:
arm 1: Taxoprexin® 400 mg/m² intravenously weekly for 5 weeks

Carboplatin was given at an Area Under the Curve (AUC) = 4 mg\*min/mL on Week 1 and Week 4, Taxoprexin and carboplatin were given up to 3 treatment cycles. arm 2: Paclitaxel 225 mg/m² intravenously followed immediately by carboplatin AUC = 6 mg\*min/mL. Paclitaxel and carboplatin were given up to 6 treatment cycles.

Interventions: intervention 1: Taxoprexin intervention 2: Carboplatin intervention 3: Paclitaxel
Intervention descriptions: intervention 1: Administered by intravenous infusion over 1 hour infusion intervention 2: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate (GFR) + 25). intervention 3: Administered by intravenous infusion over 3 hour infusion

Protocol document: