NCT00453167

Weekly Paclitaxel Plus Gemcitabine as Second-line in Small Cell Lung Cancer

A Phase II Study of Weekly Paclitaxel and Gemcitabine as Second-line Therapy in Patients With Metastatic or Recurrence Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

As a single agent, paclitaxel has a response rate of 33% and 25-29% in SCLC patients with sensitive relapse and with resistant relapse, respectively. As a single agent, gemcitabine also has a response rate 16% and 6-13% in SCLC patients with sensitive relapse and with resistant relapse, respectively. Because of single-agent activity, different mechanism of action, non-overlapping toxicities, and beneficial pharmacologic interaction, paclitaxel and gemcitabine combinations are attractive for testing in clinical trials.

Detailed description

The treatment consists of paclitaxel 80 mg/m2 and gemcitabine 1,000 mg/m2 given intravenously on days 1 and 8 of a 21-day cycle. Patients receive treatment every 3 weeks till disease progression

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel	Paclitaxel 80mg/m2 iv on day 1 and 8, every 3 weeks until disease progression
DRUG	Gemcitabine	Gemcitabine 1000mg/m2 iv on day 1 and 8, every 3 weeks until disease progression

Timeline

• Start date: 2005-12-01
• Primary completion: 2009-12-01
• Completion: 2010-03-01
• First posted: 2007-03-28
• Last updated: 2010-07-12

Locations

1 site across 1 country: South Korea