Phase II Study of Camtobell Inj.(Belotecan) in Combination With Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer

Yonsei University1 site in 1 country42 target enrollmentOctober 2008

ConditionsLung Cancer

Interventionsbelotecan hydrochloride cisplatin

Drugsbelotecan hydrochloride cisplatin

Overview

Phase: Phase 2
Intervention: belotecan hydrochloride
Conditions: Lung Cancer
Sponsor: Yonsei University
Enrollment: 42
Locations: 1
Primary Endpoint: Response rate as assessed by RECIST criteria
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Belotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving belotecan together with cisplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well belotecan works when given together with cisplatin in treating patients with previously untreated extensive stage small cell lung cancer.

Detailed Description

OBJECTIVES: Primary * To assess the antitumor efficacy, in terms of objective response rate, of belotecan hydrochloride and cisplatin in patients with previously untreated extensive-stage small cell lung cancer. Secondary * To assess additional evidence of antitumor activity as measured by overall and progression-free survival of these patients. * To determine the safety and tolerability of this drug combination in these patients. OUTLINE: Patients receive cisplatin IV on day 1 and belotecan hydrochloride IV on days 2-4.Treatment continues in the absence of disease progression or unacceptable toxicity.

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

June 2012

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group