drugset / Trial / NCT00664105

Ph II Concurrent Chemo t/Docetaxel/Carboplatin/Radio Therapy-consolidation t/Locally Adv Inoperable Non-Small Cell Lung Cancer (NSCLC)

NCT00664105 ↗

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Because of its success in advanced NSCLC both as a single agent and in combination with other chemotherapeutics, it is reasonable to investigate the efficacy and toxicity of docetaxel as a multimodality regimen in this patient population. Docetaxel at a dose of 20 mg/m2 appears to be a well-tolerated "weekly" dose when combined with either cisplatin 25 mg/m2 20-22 or carboplatin area under the curve (AUC) 2 23-25 concomitant with radiation therapy. PURPOSE: To explore the potential benefits of the radiosensitizing effects of weekly docetaxel/carboplatin/radio therapy concurrent therapy followed full dose systemic docetaxel/carboplatin consolidation therapy on overall response rate, survival, progression-free survival, safety and toxicity in patients with locally advanced NSCLC.

Timeline

Start
2004-02
Primary completion
2008-06
Completion
2008-06

Outcome

Outcome not reported

Stopped: “Treatment became standard.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 2 unknown Intravenous
Subject Carboplatin Small molecule 6 unknown Intravenous
Subject Docetaxel Small molecule 20 mg/m2 Intravenous
Subject Docetaxel Small molecule 75 mg/m2 Intravenous

Indications