At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed non-small cell lung cancer
- ✓Locally advanced (stage IIIB) or metastatic (stage IV) disease at study entry
- ✓At least one site of measurable or non-measurable disease
- ✓No prior systemic chemotherapy for metastatic disease; adjuvant chemotherapy allowed if >6 months prior
- ✕Adjuvant chemotherapy within 6 months of study entry
- ✕Symptomatic brain metastases
- ✕Peripheral neuropathy greater than grade 1
- ✕Known hypersensitivity to Cremophor
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Study of Weekly Taxoprexin Plus Carboplatin Versus Paclitaxel Plus Carboplatin as First Line Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer
In Brief
A Phase 3 clinical trial evaluating Taxoprexin, Carboplatin, and 1 other intervention for Non-Small Cell Lung Cancer. Completed, enrolled 518 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Administered by intravenous infusion over 1 hour infusion
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).
Administered by intravenous infusion over 3 hour infusion