Belotecan and Cisplatin in Treating Patients With Previously Untreated, Extensive-Stage Small Cell Lung Cancer

Phase 2

Completed

• Conditions: Lung Cancer
• Interventions: Drug: belotecan hydrochloride; Drug: cisplatin

• Registration Number: NCT00754858
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study First Submitted: 2008-09-17
• Study First Submitted QC: 2008-09-17
• Study First Posted: 2008-09-18
• Study Start: 2008-10
• Primary Completion: 2010-05
• Study Completion: 2012-06
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-26
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
belotecan and Cisplatin	belotecan hydrochloride	belotecan 0.5 mg/m2 and Cisplatin 60mg/m2
belotecan and Cisplatin	cisplatin	belotecan 0.5 mg/m2 and Cisplatin 60mg/m2

Primary Outcome Measures

Name	Time	Method
Response rate as assessed by RECIST criteria	21days(1cycle)
Overall survival	21days(1cycle)
Progression-free survival	21days(1cycle)
Hematologic and non-hematologic toxicity as assessed by NCI CTCAE v3.0	21days(1cycle)

Trial Locations

Locations (1)

Yonsei Cancer Center at Yonsei University Medical Center; 🇰🇷 Seoul, Korea, Republic of